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Once-A-Day Pregabalin For Partial Seizures

Primary Purpose

Partial Seizures, Epilepsies, Partial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin
pregabalin
pregabalin
pregabalin
pregabalin
pregabalin
placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Seizures focused on measuring Partial epilepsy, partial seizures, epilepsy, seizures, adjunctive therapy, intervention, controlled-release, placebo-controlled, seizure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
  • Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

  • Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
  • Status epilepticus within one year prior to screening

Sites / Locations

  • Neurology Clinic, PC
  • NEA Baptist Clinic
  • Clinical Trials, Inc.
  • Collaborative Neuroscience Network, Inc.
  • Viking Clinic Research Center
  • Viking Clinical Research Center
  • Neurological Research Institute
  • Viking Clinical Research Center
  • Sarkis Clinical Trials
  • Optima Neurological Services, LLC
  • Sleep Disorders Center of Georgia - Gainesville
  • Southern Illinois University School of Medicine
  • VCMA Comprehensive Epilepsy Center
  • Via Christi Research
  • Associates in Neurology, PSC
  • Mid Atlantic Headache Institute
  • Asheville Neurology Specialists, PA
  • Lynn Health Science Institute
  • Mark A. Fisher, M.D.- Private Practice
  • Sooner Clinical Research
  • Veroniqe Sebastian, MD
  • Angelique Barreto, MD
  • University of Pennsylvania
  • FutureSearch Trials of Neurology
  • Scott and White Healthcare-Office of Sponsored Research Administration
  • Scott & White Healthcare
  • Fundacion Argentina Contra las Enfermedades Neurologicas (FACENE)
  • Clinic of Neurology,Clinical Centar University Sarajevo
  • MBAL Puls AD, Nevrologichno otdelenie
  • UMBAL Dr. Georgi Stranski, Vtora nevrologichna klinika
  • DKTs Akta Medika, Konsultativen kabinet po Nevrologiya
  • MBALNP Sveti Naum EAD, Klinika po nervni bolesti za paroksizmalnite sastoyaniya,
  • Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Nevrologichno Otdelenie
  • Litomyslská nemocnice, a.s.
  • Fakultni Thomayerova nemocnice s poliklinikou,Neurologicka klinika IPVZ/FTNsP
  • Neurologicka ambulance
  • Epilepsie-Zentrum Bethel
  • Praxis fuer Neurologie und Psychiatrie, Psychotherapie
  • Klinik fuer Epileptologie, Universitaet Bonn
  • Neuro Consil GmbH
  • Epilepsieklinik fuer Erwachsene Epilepsiezentrum Kork
  • Studienzentrum Dr. Stephan Arnold
  • Pamela Youde Nethersole Eastern Hospital
  • Department of Medicine, Queen Elizabeth Hospital
  • Dr. Kennessey Albert Korhaz-Rendelointezet, Neurologiai Osztaly
  • Synexus Magyarorszag Kft.
  • Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Ideggyogyaszati Osztaly
  • Szent Pantaleon Korhaz Nonprofit Kft., Idegosztaly
  • Lalitha Super Specialities Hospital (P) Ltd.
  • Jagadguru Sri Shivathreeshwara Medical College and Hospital,
  • Deenanath Mangeshkar Hospital and Research Centre
  • Sahyadri Clinical Research & Development Center,
  • KEM Hospital Research Centre
  • Sahyadri Speciality Hospital
  • Poona Hospital and Research Centre Department of Neurology
  • Vidyasagar Institute of Mental Health , Neuro& Allied Sciences,
  • Jabatan Neurosains, Pusat Pengajian Sains Perubatan, Universiti Sains Malaysia.
  • Hospital Universiti Sains Malaysia
  • Hospital Kuala Lumpur
  • Private Office 201
  • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Hospital Angeles Culiacan
  • Instituto Biomedico de Investigacion A. C.
  • Indywidualna Specjalistyczna Praktyka Lekarska
  • Centrum Neurologii Klinicznej Sp. z o. o.
  • Gabinet Lekarski A. Klimek
  • Niepubliczny Zaklad Opieki Zdrowotnej IGNIS dr med. Alicja Lobinska
  • Epilepsy Control Institute
  • Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
  • Cabinet Medical Individual " Dr. Adina Maria Roceanu"
  • Municipal Healthcare Institution City Hospital #5, Neurology Department
  • State Medical Institution Republican Clinical Hospital
  • Central Clinical Hospital #2 N.A. Semashko OAO RZD / Department of Rehabilitation
  • Pyatigorsk City Hospital #2, Neurology Department,
  • State Institution St. Petersburg Psychoneurological Research Institute V.M. Bekhterev of Roszdrav
  • Samara Regional Clinical Hospital M.I. Kalinin, Neurology and Neurosurgery Department
  • Institute for Mental Health
  • National University Hospital
  • Singapore General Hospital
  • Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
  • Neurology Division, Department of Medicine, Pramongkutklao College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

pregabalin CR 330 mg

pregabalin CR 165 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.

Secondary Outcome Measures

Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder.
Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.
Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.
Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Change From Baseline in MOS-SS - Snoring Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale
Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal.
Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
BSW: Satisfaction From Treatment Question
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
BSW: Willingness to Continue Question
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase
Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.
Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase
Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait.
Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)
C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events.
Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase
Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema).
Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms
The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated.
Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase
The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR.
Percentage of Participants With Laboratory Test Abnormalities During the Study
Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen

Full Information

First Posted
December 16, 2010
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01262677
Brief Title
Once-A-Day Pregabalin For Partial Seizures
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 17, 2011 (Actual)
Primary Completion Date
July 31, 2012 (Actual)
Study Completion Date
August 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Seizures, Epilepsies, Partial
Keywords
Partial epilepsy, partial seizures, epilepsy, seizures, adjunctive therapy, intervention, controlled-release, placebo-controlled, seizure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregabalin CR 330 mg
Arm Type
Experimental
Arm Title
pregabalin CR 165 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matched to the active drug
Primary Outcome Measure Information:
Title
Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase
Description
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time Frame
Week 0 to Week 14
Secondary Outcome Measure Information:
Title
Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase
Description
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder.
Time Frame
Week 0 to Week 14
Title
Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase
Description
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time Frame
Week 0 to Week 14
Title
Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase
Description
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.
Time Frame
Week 0 to Week 14
Title
Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase
Description
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time Frame
Week 2 to Week 14
Title
Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase
Description
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.
Time Frame
Week 0 to Week 14
Title
Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase
Description
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time Frame
Week 2 to Week 14
Title
Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14
Description
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14
Description
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14
Description
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame
Baseline, Week 14
Title
Change From Baseline in MOS-SS - Snoring Score at Week 14
Description
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame
Baseline, Week 14
Title
Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14
Description
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame
Baseline, Week 14
Title
Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14
Description
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame
Baseline, Week 14
Title
Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14
Description
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame
Baseline, Week 14
Title
Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14
Description
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame
Baseline, Week 14
Title
Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14
Description
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame
Baseline, Week 14
Title
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14
Description
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame
Baseline, Week 14
Title
Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale
Description
Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal.
Time Frame
Week 14
Title
Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question
Description
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time Frame
Week 14
Title
BSW: Satisfaction From Treatment Question
Description
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time Frame
Week 14
Title
BSW: Willingness to Continue Question
Description
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time Frame
Week 14
Title
Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase
Description
Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.
Time Frame
Day 1 to Week 15
Title
Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase
Description
Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait.
Time Frame
Day 1 to Week 15
Title
Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)
Description
C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events.
Time Frame
Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)
Title
Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase
Description
Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema).
Time Frame
Day 1 to Week 15
Title
Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms
Description
The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated.
Time Frame
Week 15
Title
Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase
Description
The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR.
Time Frame
Week 15
Title
Percentage of Participants With Laboratory Test Abnormalities During the Study
Description
Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen
Time Frame
Day 1 to Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure) Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs Exclusion Criteria: Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome) Status epilepticus within one year prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Clinic, PC
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Clinical Trials, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Viking Clinic Research Center
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Viking Clinical Research Center
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Viking Clinical Research Center
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Optima Neurological Services, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Sleep Disorders Center of Georgia - Gainesville
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
VCMA Comprehensive Epilepsy Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Associates in Neurology, PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Mid Atlantic Headache Institute
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Asheville Neurology Specialists, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Mark A. Fisher, M.D.- Private Practice
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Veroniqe Sebastian, MD
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Angelique Barreto, MD
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Scott and White Healthcare-Office of Sponsored Research Administration
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
Scott & White Healthcare
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Fundacion Argentina Contra las Enfermedades Neurologicas (FACENE)
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1117ABE
Country
Argentina
Facility Name
Clinic of Neurology,Clinical Centar University Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
MBAL Puls AD, Nevrologichno otdelenie
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
UMBAL Dr. Georgi Stranski, Vtora nevrologichna klinika
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
DKTs Akta Medika, Konsultativen kabinet po Nevrologiya
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
MBALNP Sveti Naum EAD, Klinika po nervni bolesti za paroksizmalnite sastoyaniya,
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Nevrologichno Otdelenie
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Litomyslská nemocnice, a.s.
City
Litomysl
ZIP/Postal Code
570 14
Country
Czechia
Facility Name
Fakultni Thomayerova nemocnice s poliklinikou,Neurologicka klinika IPVZ/FTNsP
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Neurologicka ambulance
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Epilepsie-Zentrum Bethel
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Praxis fuer Neurologie und Psychiatrie, Psychotherapie
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Klinik fuer Epileptologie, Universitaet Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Neuro Consil GmbH
City
Duesseldorf
ZIP/Postal Code
40212
Country
Germany
Facility Name
Epilepsieklinik fuer Erwachsene Epilepsiezentrum Kork
City
Kehl-Kork
ZIP/Postal Code
77694
Country
Germany
Facility Name
Studienzentrum Dr. Stephan Arnold
City
Muenchen
ZIP/Postal Code
80638
Country
Germany
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Department of Medicine, Queen Elizabeth Hospital
City
Kowloon
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Dr. Kennessey Albert Korhaz-Rendelointezet, Neurologiai Osztaly
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Synexus Magyarorszag Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Ideggyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Szent Pantaleon Korhaz Nonprofit Kft., Idegosztaly
City
Dunaujvaros
ZIP/Postal Code
2400
Country
Hungary
Facility Name
Lalitha Super Specialities Hospital (P) Ltd.
City
Guntur
State/Province
Andhra Pradesh
ZIP/Postal Code
522 001
Country
India
Facility Name
Jagadguru Sri Shivathreeshwara Medical College and Hospital,
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Sahyadri Clinical Research & Development Center,
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
KEM Hospital Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 011
Country
India
Facility Name
Sahyadri Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Poona Hospital and Research Centre Department of Neurology
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Facility Name
Vidyasagar Institute of Mental Health , Neuro& Allied Sciences,
City
Nehru Nagar
State/Province
NEW Delhi
ZIP/Postal Code
110 065
Country
India
Facility Name
Jabatan Neurosains, Pusat Pengajian Sains Perubatan, Universiti Sains Malaysia.
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Universiti Sains Malaysia
City
Kelantan Darul Naim
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Private Office 201
City
Delagación Cuauhtemoc
State/Province
DF
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
CP 64460
Country
Mexico
Facility Name
Hospital Angeles Culiacan
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Instituto Biomedico de Investigacion A. C.
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska
City
Gdansk
ZIP/Postal Code
80-266
Country
Poland
Facility Name
Centrum Neurologii Klinicznej Sp. z o. o.
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Gabinet Lekarski A. Klimek
City
Lodz
ZIP/Postal Code
90-148
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej IGNIS dr med. Alicja Lobinska
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Epilepsy Control Institute
City
San Juan
ZIP/Postal Code
00923
Country
Puerto Rico
Facility Name
Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
City
Iasi
State/Province
Jud. Iasi
ZIP/Postal Code
700309
Country
Romania
Facility Name
Cabinet Medical Individual " Dr. Adina Maria Roceanu"
City
Bucuresti
ZIP/Postal Code
010042
Country
Romania
Facility Name
Municipal Healthcare Institution City Hospital #5, Neurology Department
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
State Medical Institution Republican Clinical Hospital
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
Central Clinical Hospital #2 N.A. Semashko OAO RZD / Department of Rehabilitation
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Pyatigorsk City Hospital #2, Neurology Department,
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
State Institution St. Petersburg Psychoneurological Research Institute V.M. Bekhterev of Roszdrav
City
Saint-Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Samara Regional Clinical Hospital M.I. Kalinin, Neurology and Neurosurgery Department
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Institute for Mental Health
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Neurology Division, Department of Medicine, Pramongkutklao College of Medicine
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
24962242
Citation
French J, Brandt C, Friedman D, Biton V, Knapp L, Pitman V, Chew M, Dubrava S, Posner HB. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081194&StudyName=Once-A-Day%20Pregabalin%20For%20Partial%20Seizures
Description
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Once-A-Day Pregabalin For Partial Seizures

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