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Once-A-Day Pregabalin For Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01262677
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Partial Seizures Epilepsies, Partial Drug: pregabalin Drug: placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 17, 2011
Actual Primary Completion Date : July 31, 2012
Actual Study Completion Date : August 1, 2012


Arm Intervention/treatment
Experimental: pregabalin CR 330 mg Drug: pregabalin
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days

Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for 11 days

Drug: pregabalin
Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)

Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for 7 days

Experimental: pregabalin CR 165 mg Drug: pregabalin
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days

Drug: pregabalin
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)

Placebo Comparator: Placebo Drug: placebo
matched to the active drug




Primary Outcome Measures :
  1. Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase [ Time Frame: Week 0 to Week 14 ]
    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 :
  1. Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase [ Time Frame: Week 0 to Week 14 ]
    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.

  2. Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase [ Time Frame: Week 0 to Week 14 ]
    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.

  3. Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase [ Time Frame: Week 0 to Week 14 ]
    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.

  4. Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase [ Time Frame: Week 2 to Week 14 ]
    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.

  5. Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase [ Time Frame: Week 0 to Week 14 ]
    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.

  6. Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase [ Time Frame: Week 2 to Week 14 ]
    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.

  7. Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14 [ Time Frame: Baseline, 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.

  8. Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14 [ Time Frame: Baseline, 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.

  9. Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14 [ Time Frame: Baseline, 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.

  10. Change From Baseline in MOS-SS - Snoring Score at Week 14 [ Time Frame: Baseline, 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.

  11. Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14 [ Time Frame: Baseline, 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.

  12. Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14 [ Time Frame: Baseline, 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.

  13. Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14 [ Time Frame: Baseline, 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.

  14. Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14 [ Time Frame: Baseline, 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.

  15. Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14 [ Time Frame: Baseline, 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.

  16. Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14 [ Time Frame: Baseline, 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.

  17. Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale [ Time Frame: Week 14 ]
    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.

  18. Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question [ Time Frame: Week 14 ]
    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.

  19. BSW: Satisfaction From Treatment Question [ Time Frame: Week 14 ]
    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.

  20. BSW: Willingness to Continue Question [ Time Frame: Week 14 ]
    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.

  21. Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase [ Time Frame: Day 1 to Week 15 ]
    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.

  22. Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase [ Time Frame: Day 1 to Week 15 ]
    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.

  23. Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA) [ Time Frame: Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase) ]
    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.

  24. Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase [ Time Frame: Day 1 to Week 15 ]
    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).

  25. Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms [ Time Frame: Week 15 ]
    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.

  26. Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase [ Time Frame: Week 15 ]
    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.

  27. Percentage of Participants With Laboratory Test Abnormalities During the Study [ Time Frame: Day 1 to Week 15 ]
    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



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262677


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Locations
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United States, Alabama
Neurology Clinic, PC
Northport, Alabama, United States, 35476
United States, Arkansas
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
United States, California
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States, 90806
Viking Clinic Research Center
Murrieta, California, United States, 92562
Viking Clinical Research Center
Murrieta, California, United States, 92562
Neurological Research Institute
Santa Monica, California, United States, 90404
Viking Clinical Research Center
Temecula, California, United States, 92591
United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Optima Neurological Services, LLC
Gainesville, Florida, United States, 32608
United States, Georgia
Sleep Disorders Center of Georgia - Gainesville
Gainesville, Georgia, United States, 30501
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Kansas
VCMA Comprehensive Epilepsy Center
Wichita, Kansas, United States, 67214
Via Christi Research
Wichita, Kansas, United States, 67214
United States, Kentucky
Associates in Neurology, PSC
Lexington, Kentucky, United States, 40513
United States, Maryland
Mid Atlantic Headache Institute
Pikesville, Maryland, United States, 21208
United States, North Carolina
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States, 28806
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Mark A. Fisher, M.D.- Private Practice
Oklahoma City, Oklahoma, United States, 73112
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
Veroniqe Sebastian, MD
Oklahoma City, Oklahoma, United States, 73120
Angelique Barreto, MD
Oklahoma City, Oklahoma, United States, 73135
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
Scott and White Healthcare-Office of Sponsored Research Administration
Temple, Texas, United States, 76502
Scott & White Healthcare
Temple, Texas, United States, 76508
Argentina
Fundacion Argentina Contra las Enfermedades Neurologicas (FACENE)
Ciudad Autonoma de Buenos Aires, Argentina, C1117ABE
Bosnia and Herzegovina
Clinic of Neurology,Clinical Centar University Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Bulgaria
MBAL Puls AD, Nevrologichno otdelenie
Blagoevgrad, Bulgaria, 2700
UMBAL Dr. Georgi Stranski, Vtora nevrologichna klinika
Pleven, Bulgaria, 5800
DKTs Akta Medika, Konsultativen kabinet po Nevrologiya
Sevlievo, Bulgaria, 5400
MBALNP Sveti Naum EAD, Klinika po nervni bolesti za paroksizmalnite sastoyaniya,
Sofia, Bulgaria, 1113
Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Nevrologichno Otdelenie
Sofia, Bulgaria, 1202
Czechia
Litomyslská nemocnice, a.s.
Litomysl, Czechia, 570 14
Fakultni Thomayerova nemocnice s poliklinikou,Neurologicka klinika IPVZ/FTNsP
Praha 4, Czechia, 140 59
Neurologicka ambulance
Praha 6, Czechia, 160 00
Germany
Epilepsie-Zentrum Bethel
Bielefeld, Germany, 33617
Praxis fuer Neurologie und Psychiatrie, Psychotherapie
Bielefeld, Germany, 33647
Klinik fuer Epileptologie, Universitaet Bonn
Bonn, Germany, 53105
Neuro Consil GmbH
Duesseldorf, Germany, 40212
Epilepsieklinik fuer Erwachsene Epilepsiezentrum Kork
Kehl-Kork, Germany, 77694
Studienzentrum Dr. Stephan Arnold
Muenchen, Germany, 80638
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Department of Medicine, Queen Elizabeth Hospital
Kowloon, Hong Kong, 0
Hungary
Dr. Kennessey Albert Korhaz-Rendelointezet, Neurologiai Osztaly
Balassagyarmat, Hungary, 2660
Synexus Magyarorszag Kft.
Budapest, Hungary, 1036
Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Ideggyogyaszati Osztaly
Budapest, Hungary, 1145
Szent Pantaleon Korhaz Nonprofit Kft., Idegosztaly
Dunaujvaros, Hungary, 2400
India
Lalitha Super Specialities Hospital (P) Ltd.
Guntur, Andhra Pradesh, India, 522 001
Jagadguru Sri Shivathreeshwara Medical College and Hospital,
Mysore, Karnataka, India, 570004
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India, 411 004
Sahyadri Clinical Research & Development Center,
Pune, Maharashtra, India, 411 004
KEM Hospital Research Centre
Pune, Maharashtra, India, 411 011
Sahyadri Speciality Hospital
Pune, Maharashtra, India, 411004
Poona Hospital and Research Centre Department of Neurology
Pune, Maharashtra, India, 411030
Vidyasagar Institute of Mental Health , Neuro& Allied Sciences,
Nehru Nagar, NEW Delhi, India, 110 065
Malaysia
Jabatan Neurosains, Pusat Pengajian Sains Perubatan, Universiti Sains Malaysia.
Kubang Kerian, Kelantan, Malaysia, 16150
Hospital Universiti Sains Malaysia
Kelantan Darul Naim, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Mexico
Private Office 201
Delagación Cuauhtemoc, DF, Mexico, 06700
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo LEON, Mexico, CP 64460
Hospital Angeles Culiacan
Culiacan, Sinaloa, Mexico, 80020
Instituto Biomedico de Investigacion A. C.
Aguascalientes, Mexico, 20127
Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Gdansk, Poland, 80-266
Centrum Neurologii Klinicznej Sp. z o. o.
Krakow, Poland, 31-505
Gabinet Lekarski A. Klimek
Lodz, Poland, 90-148
Niepubliczny Zaklad Opieki Zdrowotnej IGNIS dr med. Alicja Lobinska
Swidnik, Poland, 21-040
Puerto Rico
Epilepsy Control Institute
San Juan, Puerto Rico, 00923
Romania
Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
Iasi, Jud. Iasi, Romania, 700309
Cabinet Medical Individual " Dr. Adina Maria Roceanu"
Bucuresti, Romania, 010042
Russian Federation
Municipal Healthcare Institution City Hospital #5, Neurology Department
Barnaul, Russian Federation, 656045
State Medical Institution Republican Clinical Hospital
Kazan, Russian Federation, 420064
Central Clinical Hospital #2 N.A. Semashko OAO RZD / Department of Rehabilitation
Moscow, Russian Federation, 107150
Pyatigorsk City Hospital #2, Neurology Department,
Pyatigorsk, Russian Federation, 357538
State Institution St. Petersburg Psychoneurological Research Institute V.M. Bekhterev of Roszdrav
Saint-Petersburg, Russian Federation, 192019
Samara Regional Clinical Hospital M.I. Kalinin, Neurology and Neurosurgery Department
Samara, Russian Federation, 443095
Serbia
Institute for Mental Health
Belgrade, Serbia, 11 000
Singapore
National University Hospital
Singapore, Singapore, 119074
Singapore General Hospital
Singapore, Singapore, 169608
Thailand
Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
Muang, Khon Kaen, Thailand, 40002
Neurology Division, Department of Medicine, Pramongkutklao College of Medicine
Bangkok, Thailand, 10400
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01262677     History of Changes
Other Study ID Numbers: A0081194
2010-019035-35 ( EudraCT Number )
First Posted: December 17, 2010    Key Record Dates
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018
Last Verified: April 2018
Keywords provided by Pfizer:
Partial epilepsy
partial seizures
epilepsy
seizures
adjunctive therapy
intervention
controlled-release
placebo-controlled
seizure
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs