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The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).
This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | 150 to 600 mg/day during 21 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase | 28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency. | Week 9 to Week 21 or End of Treatment (early termination) |
| Measure | Description | Time Frame |
|---|---|---|
| Response Ratio (RR) | Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures. | Week 9 to Week 21 or End of Treatment (early termination) |
Not provided
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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | México | D. F. | CP 06700 | Mexico | ||
| Pfizer Investigational Site |
A total of 152 subjects were screened and 136 subjects were assigned to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | 150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | 150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase | 28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency. | Full Analysis Set (FAS): all subjects who received at least 1 dose of assigned treatment, had valid baseline seizure data, and had at least 1 subsequent rating of seizure frequency (modified intent to treat population). N=number of subjects with evaluable data. | Posted | Mean | Standard Deviation | percent change | Week 9 to Week 21 or End of Treatment (early termination) |
|
Not provided
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same 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 | Pregabalin | 75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D012640 | Seizures |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
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| Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21 | Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.](streamdown:incomplete-link) | Week 21 or End of Treatment (early termination) |
| Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period | Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency. | Week 9 to Week 21 or End of Treatment (early termination) |
| Percent of Seizure- Free Participants During the Treatment Observation Period | Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline). | Week 9 to Week 21 or Early Termination (end of treatment) |
| Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period | Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline). | Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) |
| Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period | Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) |
| Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period | Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9) |
| Treatment Satisfaction: Patient General Impression to Change (PGIC) | Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC. | Week 21, LOCF |
| Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b. | Week 21, LOCF |
| Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale | Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b. | Week 21, LOCF |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) | Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b. | Week 21, LOCF |
| Acapulco de Juárez |
| Guerrero |
| 39670 |
| Mexico |
| Pfizer Investigational Site | Morelia | Michoacán | CP 58000 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64060 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Pfizer Investigational Site | Aguascalientes | 20127 | Mexico |
| Pfizer Investigational Site | Chihuahua City | 31238 | Mexico |
| Pfizer Investigational Site | Estado de México | CP 52763 | Mexico |
| Withdrawal by Subject |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 28-Day Seizure Rate | Number of partial seizures in baseline period divided by duration of period based on observed visit dates multiplied by 28. | Mean | Standard Deviation | seizure rate |
|
| 28 day seizure frequency in Subjects with <= 6 and > 6 seizures during Baseline Period | Baseline period = 8 week period before Visit 1 date, including any unplanned readings falling under this period. | Mean | Standard Deviation | seizures |
|
| Medical Outcomes Study Sleep Scale | Subject rated questionnaire to assess sleep quality and quantity. For 5 of 7 subscales transformed total score range = 0 to 100; other subscales: Sleep Quantity range: 0-24 hours; and Optimal Sleep range: 1 (optimal sleep: quantity 7 or 8 hours per night), or 0 (no optimal sleep). Higher score indicates greater intensity or quantity of attribute. | Mean | Standard Deviation | scores on scale |
|
| Hospital Anxiety and Depression Scale (HADS) | HADS-A: generalized anxiety; HADS-D: lost interest and diminished pleasure response (lowering of hedonic tone). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. | Mean | Standard Deviation | score on scale |
|
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|
|
| Secondary | Response Ratio (RR) | Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures. | FAS. N=number of subjects with evaluable data. | Posted | Mean | Standard Deviation | ratio | Week 9 to Week 21 or End of Treatment (early termination) |
|
|
|
|
| Secondary | Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21 | Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.](streamdown:incomplete-link) | FAS. | Posted | Mean | Standard Deviation | percent change | Week 21 or End of Treatment (early termination) |
|
|
|
|
| Secondary | Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period | Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency. | FAS. N=number of subjects with evaluable data. | Posted | Mean | Standard Deviation | percent change | Week 9 to Week 21 or End of Treatment (early termination) |
|
|
|
|
| Secondary | Percent of Seizure- Free Participants During the Treatment Observation Period | Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline). | FAS. N=number of subjects with evaluable data. | Posted | Number | percent of participants | Week 9 to Week 21 or Early Termination (end of treatment) |
|
|
|
| Secondary | Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period | Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline). | FAS. N=number of subjects with evaluable data. | Posted | Number | percent of participants | Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) |
|
|
|
| Secondary | Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period | FAS. N=number of subjects with evaluable data. | Posted | Number | percent of participants | Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) |
|
|
|
| Secondary | Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period | FAS. N=number of subjects with evaluable data. | Posted | Number | percent of participants | Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9) |
|
|
|
| Secondary | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC. | FAS. LOCF = Last Observation Carried Forward. | Posted | Number | percent of participants | Week 21, LOCF |
|
|
|
| Secondary | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b. | FAS. LOCF = Last Observation Carried Forward. | Posted | Mean | Standard Deviation | scores on scale | Week 21, LOCF |
|
|
|
|
| Secondary | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale | Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b. | FAS. LOCF=Last Observation Carried Forward. | Posted | Mean | Standard Deviation | scores on scale | Week 21, LOCF |
|
|
|
|
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) | Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b. | FAS. LOCF = Last Observation Carried Forward. | Posted | Mean | Standard Deviation | scores on scale | Week 21, LOCF |
|
|
|
|
| 8 |
| 136 |
| 91 |
| 136 |
| Drug intolerance | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Partial seizures with secondary generalization | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctival irritation | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tootheache | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Overweight | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyslalia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Agoraphobia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Spontaneous penile erection | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Scar | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
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.
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| <.0001 |
| 2-Sided |
| 95 |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| Week 21: No Change |
|
| Week 21: Minimally Worse |
|
| Week 21: Much Worse |
|
| Week 21: Very Much Worse |
|
| Week 21: Not Done |
|
| LOCF: Very Much Improved |
|
| LOCF: Much Improved |
|
| LOCF: Minimally Improved |
|
| LOCF: No Change |
|
| LOCF: Minimally Worse |
|
| LOCF: Much Worse |
|
| LOCF: Very Much Worse |
|
| LOCF: Not Done |
|
| Title | Measurements |
|---|---|
|
| LOCF: Snoring |
|
| Week 21: Awaken Short of Breath |
|
| LOCF: Awaken Short of Breath |
|
| Week 21: Adequacy |
|
| LOCF: Adequacy |
|
| Week 21: Somnolence |
|
| LOCF: Somnolence |
|
| Week 21: 9-Item Overall Sleep Problem Index |
|
| LOCF: 9-Item Overall Sleep Problem Index |
|
| Week 21: Sleep Quantity |
|
| LOCF: Sleep Quantity |
|
| t-test, 2 sided |
| 0.0350 |
| 2-Sided |
| 95 |
| Superiority or Other (legacy) |
| Week 21: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.6743 | 2-Sided | Superiority or Other (legacy) |
| LOCF: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.4736 | 2-Sided | Superiority or Other (legacy) |
| Week 21: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.8173 | 2-Sided | Superiority or Other (legacy) |
| LOCF: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.9092 | 2-Sided | Superiority or Other (legacy) |
| Week 21: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.1091 | 2-Sided | Superiority or Other (legacy) |
| LOCF: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.0944 | 2-Sided | Superiority or Other (legacy) |
| Week 21: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.8928 | 2-Sided | Superiority or Other (legacy) |
| LOCF: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.7669 | 2-Sided | Superiority or Other (legacy) |
| Week 21: 9-Item Overall Sleep Problems Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.1698 | 2-Sided | Superiority or Other (legacy) |
| LOCF: 9-Item Overall Sleep Problem Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.0898 | 2-Sided | Superiority or Other (legacy) |
| Week 21: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.0465 | 2-Sided | Superiority or Other (legacy) |
| LOCF: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.0316 | 2-Sided | Superiority or Other (legacy) |
| t-test, 2 sided |
| 0.1905 |
| 2-Sided |
| 95 |
| Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| LOCF: Depression |
|
| t-test, 2 sided |
| <.0001 |
| 2-Sided |
| 95 |
| Superiority or Other (legacy) |
| Depression: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.0799 | 2-Sided | Superiority or Other (legacy) |
| Depression: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero. | t-test, 2 sided | 0.0846 | 2-Sided | Superiority or Other (legacy) |