Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005630-60 | EudraCT Number |
Not provided
Not provided
New Safety Information
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Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).
During Part A, each patient will participate for up to 30 weeks, which includes a Screening Period of 1 to ≤ 6 weeks, followed by a Baseline Visit and 24 weeks of double-blind treatment:
After completion of Part A, patients will continue in Part B for an additional 56 weeks:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tozadenant 60 mg BID | Experimental | During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day. Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B. |
|
| Tozadenant 120 mg BID | Experimental | During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day. Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B. |
|
| Placebo BID | Placebo Comparator | During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day. Upon completion of Part A, all patients will begin dosing with open label tozadenant in Part B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tozadenant | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time | Awake time in OFF state (hr) is the average of maximum of 3 days diary. The primary efficacy endpoint was the change from baseline to Week 24 in OFF time, where OFF time in the Hauser Parkinson's Disease Home Diary (PD) was averaged over 3 days prior to the study visit. During Screening and through Part A of the study, the Hauser Parkinson's Disease Home Diary (PD) was completed on specified days directly preceding the scheduled study visits/assessments. Motor activity was recorded as OFF, ON (mobility improved), or asleep time. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia". Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep. | Baseline to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Good ON Time From Baseline to Week 24 | The first key secondary efficacy endpoint was the change from baseline to Week 24 in good ON which was defined as ON without dyskinesia or ON with non-troublesome dyskinesia. Awake Time in Good ON State (hr) is the average of a maximum of 3 days diary. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia" . Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep. For patients with missing baseline or baseline was measured post-dose, screening was used as baseline in the calculation of change from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24 | For the Clinical Global Impression of Improvement (CGI-I), the investigator or rater is asked to rate the patient's total improvement, whether or not in his or her judgment it is due entirely to drug treatment, based on a 1-7 point weighted scale ranging from "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed. Scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. Tables show Treatment vs Placebo. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Kenney, MD | Biotie Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35005 | United States | |||
Not provided
This study was conducted at 80 sites in 7 countries. Planned patient enrollment numbers were achieved, but the study and the tozadenant development program were terminated prior to study completion by all patients, based on an unexpected emerging safety signal as discussed in the safety sections of this report.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tozadenant 60 mg BID | During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day. |
| FG001 | Tozadenant 120 mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2017 | Jan 8, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
|
|
| Baseline to 24 Weeks |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function | The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale to monitor Parkinson's Disease related disability and impairment. The scale itself has 4 components are titled; (1) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. In this outcome measure we are evaluating Part II and Part III. Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Range of score is 0 - 160: 0 meaning less impact and Higher score indicates greater impact of PD symptoms. | Baseline to Week 24 |
| Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl | Change from Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS) Parts III Motor Function (motor subscale) total scores. Each subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Range of score is 0 - 108. Higher scores indicate greater impact of PD symptoms. Unified Parkinson's Disease Rating Scale (UPDRS) in the ON state was measured at a time representative of the ON state in that patient, not in "best" ON. Unified Parkinson's Disease Rating Scale Part III in OFF was not evaluated. | Baseline to Week 24 |
| At Week 24 |
| Patient Global Impression of Improvement (PGI-I) Week 24 | For the Patient Global Impression of Improvement (PG-I), the patient is asked to rate the total improvement of their Parkinson's Disease, whether or not in the patient's judgment it is due entirely to drug treatment, based on a 1-7 point weighted scale. "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed. Scale: 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severly ill, 7 = Among the most extremely ill. Tables show Treatment vs Placebo. | At Week 24 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Loma Linda | California | 92318 | United States |
| Los Angeles | California | 90001 | United States |
| Oxnard | California | 93030 | United States |
| Reseda | California | 91335 | United States |
| Sacramento | California | 914203 | United States |
| Sunnyvale | California | 94043 | United States |
| Englewood | Colorado | 80110 | United States |
| Vernon | Connecticut | 06029 | United States |
| Boca Raton | Florida | 33428 | United States |
| Gainesville | Florida | 32601 | United States |
| Jacksonville | Florida | 32034 | United States |
| Tampa | Florida | 33601 | United States |
| Atlanta | Georgia | 30301 | United States |
| Augusta | Georgia | 30805 | United States |
| Chicago | Illinois | 60007 | United States |
| Kansas City | Kansas | 66012 | United States |
| Lexington | Kentucky | 40502 | United States |
| Baltimore | Maryland | 21201 | United States |
| Boston | Massachusetts | 02101 | United States |
| East Lansing | Michigan | 48808 | United States |
| Farmington Hills | Michigan | 48167 | United States |
| West Bloomfield | Michigan | 48302 | United States |
| St Louis | Missouri | 63101 | United States |
| Albany | New York | 12084 | United States |
| Commack | New York | 11725 | United States |
| Rochester | New York | 14602 | United States |
| Asheville | North Carolina | 28715 | United States |
| Durham | North Carolina | 27517 | United States |
| Cincinnati | Ohio | 41073 | United States |
| Cleveland | Ohio | 44101 | United States |
| Toledo | Ohio | 43460 | United States |
| Tulsa | Oklahoma | 74008 | United States |
| Philadelphia | Pennsylvania | 19019 | United States |
| Nashville | Tennessee | 37011 | United States |
| Houston | Texas | 77001 | United States |
| Burlington | Vermont | 05401 | United States |
| Roanoke | Virginia | 24001 | United States |
| Kirkland | Washington | 98033 | United States |
| Innsbruck | Austria |
| Vienna | Austria |
| Edmonton | Alberta | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Brno | Czechia |
| Choceň | Czechia |
| Pardubice | Czechia |
| Prague | Czechia |
| Rychnov nad Kněžnou | Czechia |
| Beelitz-Heilstätten | Germany |
| Berlin | Germany |
| Dresden | Germany |
| Haag in Oberbayern | Germany |
| Marburg | Germany |
| Ulm | Germany |
| Arcugnano | Italy |
| Cassino | Italy |
| Chieti | Italy |
| Grosseto | Italy |
| Pavia | Italy |
| Pisa | Italy |
| Rome | Italy |
| Salerno | Italy |
| Venice | Italy |
| Manresa | Barcelona | Spain |
| Sant Cugat del Vallès | Barcelona | Spain |
| Terrassa | Barcelona | Spain |
| Donostia / San Sebastian | Guipuzcoa | Spain |
| Barcelona | Spain |
| Madrid | Spain |
During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
| FG002 | Placebo BID | During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The 449 patients who were randomized in the study comprised the ITT set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tozadenant 60 mg BID | During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day. |
| BG001 | Tozadenant 120 mg BID | During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day. |
| BG002 | Placebo BID | During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight at Screening | Mean | Standard Deviation | kilograms |
|
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time | Awake time in OFF state (hr) is the average of maximum of 3 days diary. The primary efficacy endpoint was the change from baseline to Week 24 in OFF time, where OFF time in the Hauser Parkinson's Disease Home Diary (PD) was averaged over 3 days prior to the study visit. During Screening and through Part A of the study, the Hauser Parkinson's Disease Home Diary (PD) was completed on specified days directly preceding the scheduled study visits/assessments. Motor activity was recorded as OFF, ON (mobility improved), or asleep time. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia". Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep. | Modified Intent-to-Treat (mITT) population | Posted | Mean | Standard Deviation | hours | Baseline to 24 Weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change in Good ON Time From Baseline to Week 24 | The first key secondary efficacy endpoint was the change from baseline to Week 24 in good ON which was defined as ON without dyskinesia or ON with non-troublesome dyskinesia. Awake Time in Good ON State (hr) is the average of a maximum of 3 days diary. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia" . Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep. For patients with missing baseline or baseline was measured post-dose, screening was used as baseline in the calculation of change from baseline. | Modified Intent-to-Treat (mITT) population | Posted | Mean | Standard Deviation | hours | Baseline to 24 Weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function | The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale to monitor Parkinson's Disease related disability and impairment. The scale itself has 4 components are titled; (1) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. In this outcome measure we are evaluating Part II and Part III. Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Range of score is 0 - 160: 0 meaning less impact and Higher score indicates greater impact of PD symptoms. | mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl | Change from Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS) Parts III Motor Function (motor subscale) total scores. Each subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Range of score is 0 - 108. Higher scores indicate greater impact of PD symptoms. Unified Parkinson's Disease Rating Scale (UPDRS) in the ON state was measured at a time representative of the ON state in that patient, not in "best" ON. Unified Parkinson's Disease Rating Scale Part III in OFF was not evaluated. | mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24 | For the Clinical Global Impression of Improvement (CGI-I), the investigator or rater is asked to rate the patient's total improvement, whether or not in his or her judgment it is due entirely to drug treatment, based on a 1-7 point weighted scale ranging from "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed. Scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. Tables show Treatment vs Placebo. | mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit. Patients were accounted for in the treatment group to which they were originally randomized. | Posted | Mean | Standard Deviation | score on a scale | At Week 24 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient Global Impression of Improvement (PGI-I) Week 24 | For the Patient Global Impression of Improvement (PG-I), the patient is asked to rate the total improvement of their Parkinson's Disease, whether or not in the patient's judgment it is due entirely to drug treatment, based on a 1-7 point weighted scale. "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed. Scale: 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severly ill, 7 = Among the most extremely ill. Tables show Treatment vs Placebo. | mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit. Patients were accounted for in the treatment group to which they were originally randomized. | Posted | Mean | Standard Deviation | score on a scale | At Week 24 |
|
24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
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 | Tozadenant 60 mg BID | Part A (double-blind phase) During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day. | 1 | 150 | 13 | 150 | 115 | 150 |
| EG001 | Tozadenant 120 mg BID | Part A (double-blind phase) During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day. | 1 | 149 | 12 | 149 | 111 | 149 |
| EG002 | Placebo BID | Part A (double-blind phase) During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day. | 1 | 148 | 15 | 148 | 111 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Sudden onset of sleep | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| White Blood cell count decreased | Investigations | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 19.1, 20.0, | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kenney, Senior Vice President - Medical Affairs | Acorda Therapeutics | 914-326-5775 | ckenney@acorda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2015 | Jan 8, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000593256 | tozadenant |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| 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 |
|
| Austria |
|
| United States |
|
| Czechia |
|
| Italy |
|
| Germany |
|
| Spain |
|
| Week 2 |
|
|
| Week 6 |
|
|
| Week 12 |
|
|
| Week 18 |
|
|
| Week 24 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 |
| Tozadenant 120 mg |
Two 60 mg tozadenant tablets BID |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|