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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004912-39 | EudraCT Number | ||
| A-ROSE PD | Other Identifier | Alias Study Number | |
| A-ROSE | Other Identifier | Alias Study Number |
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Terminated 25Sep17 due to insufficient efficacy. Not due to safety reasons.
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The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.
The study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 198 subjects will be randomized to 5 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| PF-06649751 low dose (1 mg QD) | Experimental | PF-06649751 low dose level (1 mg QD) |
|
| PF-06649751 middle dose 1 (3 mg QD) | Experimental | PF-06649751 lower middle dose 1 (3 mg QD) |
|
| PF-06649751 middle dose 2 (7 mg QD) | Experimental | PF-06649751 higher middle dose 2 (7 mg QD) |
|
| PF-06649751 high dose (15 mg QD) | Experimental | PF-06649751 high dose (15 mg QD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| PF-06649751 low dose (1 mg QD) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily OFF Time at Week 10 | A paper Hauser diary was utilized to record motor state for half-hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit. | Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily OFF Time | A paper Hauser diary was utilized to record motor state for half hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xenoscience, Inc | Phoenix | Arizona | 85004 | United States | ||
| St Joseph's Hospital and Medical Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2017 | Oct 29, 2018 |
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| Drug |
PF-06649751 low dose (1 mg QD) |
|
| PF-06649751 middle dose 1 (3 mg QD) | Drug | PF-06649751 lower middle dose 1 (3 mg QD) |
|
| PF-06649751 middle dose 2 (7 mg QD) | Drug | PF-06649751higher middle dose 2 (7 mg QD) |
|
| PF-06649751 high dose (15 mg QD) | Drug | PF-06649751 high dose (15 mg QD) |
|
| Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0). |
| Change From Baseline in Daily ON Time With Troublesome Dyskinesia | A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON with troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10. | Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0). |
| Change From Baseline in Daily ON Time Without Troublesome Dyskinesia | A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON without troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10. | Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0) |
| Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | MDS-UPDRS Part III assessed the motor signs of Parkinson's disease and was administered by the investigator. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. If more than 7 of the Part III items were missing, the score for that time point was missing, otherwise MDS-UPDRS Part III score was imputed as sum of the non-missing items*(total number of items)/ (number of items non-missing). The MDS-UPDRS Part III total score range is 0-132. Higher score indicated more severe motor signs of Parkinson's disease. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10. | Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement |
| Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score | Each question of Part I,II or IV with 5 responses was linked to the same clinical terms as Part III.The score was missing if more than 7 items were missing for a time point; otherwise Part I,II or IV score was imputed as sum of non-missing items*(total number of items)/(number of items non-missing).•PartI (Non-Motor Aspects of Experiences of Daily Living) assessed non-motor experiences of daily living using 13questions(Range:0-52).•PartII(Motor Aspects of Experiences of Daily Living) assessed motor experiences of daily living using 13questions(Range:0-52).•PartIV(Motor Complications) assessed motor complications,dyskinesias, and motor fluctuations using historical and objective information with 6questions(Range:0-24).•MDS-UPDRS Total Score:the sum of Parts I,II,III,and IV(Range:0-260).Higher score indicated more severe motor signs of Parkinson's disease.Week15's results were interpreted cautiously given almost half participants were not available for the analysis as compared to Week10 | Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Determination if there were any laboratory data abnormalities of potential clinical concern was based on Pfizer Data Standards. Incidence of laboratory test abnormalities (without regard to baseline abnormality) was summarized within each treatment group. | Baseline (Day 0) to Week 17 |
| Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization | Vital Signs including blood pressure and pulse rate were measured. Vital signs were collected first while the participant was in the supine position and then in the standing position. | Baseline (Day 0) to Week 17 |
| Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization | The average of the triplicate readings of ECG data was collected at each assessment time. Number of participants with ECG results meeting the criteria for categorical summarization for time from the beginning of the P wave until the beginning of the QRS complex (PR Interval), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS Duration), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT Interval) and corrected QT (Fridericia correction) (QTcF Interval) were presented. | Baseline (Day 0) to Week 17 |
| Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits | The Columbia Suicide Severity Rating Scale (C-SSRS) was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the C-CASA. There were 3 key endpoints for suicidality data analysis and evaluation:
| Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119 |
| Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) | The QUIP-RS was a brief, patient reported outcome measure designed to assess the severity of symptoms of Impulsive-Compulsive Disorders (ICDs) and related behaviors reported to occur in Parkinson's disease. The QUIP-RS assessed 7 disorders (Gambling, Sex, Buying, Eating, Hobbyism-punding [performing tasks and repeating activities] and Taking medications). If more than 5 items were missing, the total QUIP-RS score was set as missing; otherwise, the total QUIP-RS score was imputed as follows: sum of the non-missing item scores * (total number of items) / (number of items non-missing). The higher score indicated a greater level of the ICD. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112. | Baseline (Day 0) and Weeks 5, 10 and 15 |
| Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119 | The PWC-20 is a physician completed, 20 item reliable and sensitive instrument for the assessment of discontinuation symptoms. The PWC-20 was collected after the completion of study treatment and also at the first visit of follow-up. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. If more than 5 items were missing, the total PWC-20 score was missing; otherwise, the total PWC-20 score was imputed as follows: sum of the non-missing items * (total number of items) / (number of items non-missing). The higher score indicated more frequent/severe symptoms. | Days 105 and 119 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths | An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not need necessarily to have a causal relationship with the treatment or usage. An SAE was any untoward medical occurrence at any dose that:
| Day 1 to follow-up (Week 19 visit) |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Arcadia Neurology Center | Arcadia | California | 91006 | United States |
| Faculty Physicians and Surgeons of Loma Linda University School of Medicine | Loma Linda | California | 92354 | United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | United States |
| Hoag Memorial Hospital | Newport Beach | California | 92663 | United States |
| SC3 Research Group, Inc | Pasadena | California | 91105 | United States |
| Neurosearch-Torrance | Torrance | California | 90505 | United States |
| Associated Neurologists of Southern Connecticut, PC | Fairfield | Connecticut | 06824 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| University of Florida Center for Movement Disorders and Neurorestoration | Gainesville | Florida | 32607 | United States |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Vero Beach Neurology and Research Institute | Vero Beach | Florida | 32960 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Indiana University Health Neuroscience Center | Indianapolis | Indiana | 46202 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| CRI Worldwide, LLC | Marlton | New Jersey | 08053 | United States |
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| Dent Neurologic Institute | Orchard Park | New York | 14127 | United States |
| Duke University Medical center | Durham | North Carolina | 27705 | United States |
| Duke University/Duke Neurology/Department of Neurology | Durham | North Carolina | 27705 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74136 | United States |
| Abington Neurological Associates, Ltd. | Willow Grove | Pennsylvania | 19090 | United States |
| Rhode Island Hospital/ Brown University Medical School | Providence | Rhode Island | 02903 | United States |
| AS Clinical Research Consultants of North Texas, PLLC | Greenville | Texas | 75401 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Booth Gardner Parkinson's Care Center | Kirkland | Washington | 98034 | United States |
| Montreal Neurological Hospital Research Pharmacy | Montreal | Quebec | H3A 2B4 | Canada |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | H3A 2B4 | Canada |
| CHU de Grenoble Alpes | Grenoble | 38043 Cedex 9 | France |
| CHU de Grenoble Alpes | La Tronche | 38700 | France |
| CHRU de Lille-Hopital Roger Salengro | Lille | 59037 cedex | France |
| Hopital de la Timone APHM | Marseille | 13385 cedex 05 | France |
| Hopital de La Timone | Marseille | 13385 cedex 05 | France |
| Hopital La Pitie-Salpetriere | Paris | 75013 | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| St. Josef-Hospital GmbH | Bochum | 44791 | Germany |
| Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie | Dresden | 01307 | Germany |
| Klinikum rechts der Isar der Technischen Universitaet Muenchen | München | 81675 | Germany |
| Universitaetsklinik Ulm | Ulm | 89081 | Germany |
| Asahikawa Medical center | Asahikawa | Hokkaido | 0708644 | Japan |
| Medical Corporation Abe Neurology Clinic | Morioka | Iwate | 020-0878 | Japan |
| Tazuke Kofukai Medical Research Institute Kitano Hospital | Kita-ku | Osaka | 530-8480 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Hospital Clinico Universitario | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Policlinica de Guipuzcoa | Donostia / San Sebastian | Guipuzcoa | 20009 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario y Politecnico la Fe | Valencia | 46026 | Spain |
| FG001 | PF-06649751 1 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| FG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| FG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| FG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| BG001 | PF-06649751 1 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| BG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| BG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| BG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Daily OFF Time at Week 10 | A paper Hauser diary was utilized to record motor state for half-hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit. | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Posted | Least Squares Mean | Standard Error | Hours | Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0). |
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| Secondary | Change From Baseline in Daily OFF Time | A paper Hauser diary was utilized to record motor state for half hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10. | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Posted | Least Squares Mean | Standard Error | Hours | Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0). |
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| Secondary | Change From Baseline in Daily ON Time With Troublesome Dyskinesia | A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON with troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10. | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Posted | Least Squares Mean | Standard Error | Hours | Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0). |
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| Secondary | Change From Baseline in Daily ON Time Without Troublesome Dyskinesia | A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON without troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10. | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Posted | Least Squares Mean | Standard Error | Hours | Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0) |
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| Secondary | Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | MDS-UPDRS Part III assessed the motor signs of Parkinson's disease and was administered by the investigator. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. If more than 7 of the Part III items were missing, the score for that time point was missing, otherwise MDS-UPDRS Part III score was imputed as sum of the non-missing items*(total number of items)/ (number of items non-missing). The MDS-UPDRS Part III total score range is 0-132. Higher score indicated more severe motor signs of Parkinson's disease. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10. | Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary). | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement |
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| Secondary | Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score | Each question of Part I,II or IV with 5 responses was linked to the same clinical terms as Part III.The score was missing if more than 7 items were missing for a time point; otherwise Part I,II or IV score was imputed as sum of non-missing items*(total number of items)/(number of items non-missing).•PartI (Non-Motor Aspects of Experiences of Daily Living) assessed non-motor experiences of daily living using 13questions(Range:0-52).•PartII(Motor Aspects of Experiences of Daily Living) assessed motor experiences of daily living using 13questions(Range:0-52).•PartIV(Motor Complications) assessed motor complications,dyskinesias, and motor fluctuations using historical and objective information with 6questions(Range:0-24).•MDS-UPDRS Total Score:the sum of Parts I,II,III,and IV(Range:0-260).Higher score indicated more severe motor signs of Parkinson's disease.Week15's results were interpreted cautiously given almost half participants were not available for the analysis as compared to Week10 | Full Analysis Set included all participants randomized who completed at least 1 postdose efficacy measurement(Hauser home diary). | Posted | Mean | Standard Deviation | units on a scale | Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement |
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| Secondary | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Determination if there were any laboratory data abnormalities of potential clinical concern was based on Pfizer Data Standards. Incidence of laboratory test abnormalities (without regard to baseline abnormality) was summarized within each treatment group. | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo. | Posted | Count of Participants | Participants | Baseline (Day 0) to Week 17 |
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| Secondary | Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization | Vital Signs including blood pressure and pulse rate were measured. Vital signs were collected first while the participant was in the supine position and then in the standing position. | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories. | Posted | Count of Participants | Participants | Baseline (Day 0) to Week 17 |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization | The average of the triplicate readings of ECG data was collected at each assessment time. Number of participants with ECG results meeting the criteria for categorical summarization for time from the beginning of the P wave until the beginning of the QRS complex (PR Interval), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS Duration), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT Interval) and corrected QT (Fridericia correction) (QTcF Interval) were presented. | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories. | Posted | Count of Participants | Participants | Baseline (Day 0) to Week 17 |
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| Secondary | Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits | The Columbia Suicide Severity Rating Scale (C-SSRS) was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the C-CASA. There were 3 key endpoints for suicidality data analysis and evaluation:
| Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points. | Posted | Count of Participants | Participants | Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119 |
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| Secondary | Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) | The QUIP-RS was a brief, patient reported outcome measure designed to assess the severity of symptoms of Impulsive-Compulsive Disorders (ICDs) and related behaviors reported to occur in Parkinson's disease. The QUIP-RS assessed 7 disorders (Gambling, Sex, Buying, Eating, Hobbyism-punding [performing tasks and repeating activities] and Taking medications). If more than 5 items were missing, the total QUIP-RS score was set as missing; otherwise, the total QUIP-RS score was imputed as follows: sum of the non-missing item scores * (total number of items) / (number of items non-missing). The higher score indicated a greater level of the ICD. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112. | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0) and Weeks 5, 10 and 15 |
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| Secondary | Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119 | The PWC-20 is a physician completed, 20 item reliable and sensitive instrument for the assessment of discontinuation symptoms. The PWC-20 was collected after the completion of study treatment and also at the first visit of follow-up. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. If more than 5 items were missing, the total PWC-20 score was missing; otherwise, the total PWC-20 score was imputed as follows: sum of the non-missing items * (total number of items) / (number of items non-missing). The higher score indicated more frequent/severe symptoms. | Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Days 105 and 119 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths | An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not need necessarily to have a causal relationship with the treatment or usage. An SAE was any untoward medical occurrence at any dose that:
| Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo. | Posted | Count of Participants | Participants | Day 1 to follow-up (Week 19 visit) |
|
Day 1 to follow-up (Week 19 visit)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | The participants swallowed 3 tablets once daily (QD) at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks. A follow-up visit was at Week 17, 2 weeks after discontinuation of Placebo. A follow-up phone visit was scheduled at Week 19 for participant's safety. | 1 | 23 | 1 | 23 | 15 | 23 |
| EG001 | PF-06649751 1 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. | 0 | 13 | 1 | 13 | 7 | 13 |
| EG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. | 0 | 15 | 0 | 15 | 11 | 15 |
| EG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. | 0 | 13 | 0 | 13 | 10 | 13 |
| EG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. | 1 | 44 | 2 | 44 | 31 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Allergic oedema | Immune system disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Depersonalisation/derealisation disorder | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Dysphemia | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Hypersexuality | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Rapid eye movement sleep behaviour disorder | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 20.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA version 20.1 | Non-systematic Assessment |
|
The study was terminated prematurely due to insufficient efficacy and not due to safety reasons.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 22, 2016 | Oct 29, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
|
|
| OG001 | PF-06649751 1 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
|
|
| OG001 | PF-06649751 1 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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| OG001 | PF-06649751 1 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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| OG001 | PF-06649751 1 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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| OG001 | PF-06649751 1 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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| OG002 | PF-06649751 3 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG003 | PF-06649751 7 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
| OG004 | PF-06649751 15 mg QD | The participants swallowed 3 tablets QD at approximately the same time each morning within approximately 5 minutes without being manipulated or chewed prior to being swallowed. Duration of treatment was 15 weeks including: 3-week titration of PF-06649751 administered QD to the randomized target dose; 2-week stabilization period for dose adjustment after reaching the target dose; 5-week Period A of PF-06649751 administered QD adjunctive to stable doses of L-Dopa; 5-week Period B (maintenance period) of PF-06649751 administered QD adjunctive to stable doses of L-Dopa. A follow-up visit was at Week 17, 2 weeks after discontinuation of PF-06649751. A follow-up phone visit was scheduled at Week 19 for participant's safety. |
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