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Clinical Trials/CTRI/2011/08/001976
CTRI/2011/08/001976
Completed
Phase 3

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 - Protocol A0081194

Pfizer Limited7 sites in 1 country264 target enrollmentStarted: September 24, 2011Last updated:
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Overview

Phase
Phase 3
Status
Completed
Enrollment
264
Locations
7
Primary Endpoint
The primary endpoint will be the log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the double blind maintenance treatment phase
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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This is an adjunctive (add-on) therapy in adult subjects with partial onset seizures with or without secondary generalization. This study is a randomized, double-blind, placebo-controlled, parallel group multi-center trial. This compares the efficacy of 2 different dosages of pregabalin CR (165 mg and 330 mg) dosed once daily as compared to placebo when used as adjunctive (add-on) therapy in subjects requiring adjunctive therapy in partial onset epilepsy. This study was conducted at 7 sites in India with 32 subjects of which 24 subjects have entered into treatment. The study is completed and the sites are closed out.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure) 2.Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs .
  • •subjects need to have 6 seizures during the 8 week screening period with no 4 week period with zero seizures In India as per DCGI Directive, subjects aged greater than equal to 18 years and les than equal to 65 years should be enrolled in the study.

Exclusion Criteria

  • •1.Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome) 2.Status epilepticus within one year prior to screening.

Outcomes

Primary Outcomes

The primary endpoint will be the log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the double blind maintenance treatment phase

Time Frame: Week 0 to week 14

Secondary Outcomes

  • 1.Evaluation for safety using adverse event data, medical history, PHQ 8, laboratory data, physical exams, vital signs, neurological exams, electrocardiograms, and suicidality assessment(Screening to Week 15)
  • 2.Responder rate (proportion of subjects who have a greater than or equal to 50% reduction in partial seizure rate from baseline during the double blind maintenance treatment phase compared to the 8 week baseline (screening) seizure phase).(Screening to Week 15)
  • 3.The percentage change in 28 day partial seizure rates summarized by treatment group(Screening to Week 15)
  • 4.Frequency of secondary generalized tonic clonic seizures (SGTC).(Screening to Week 15)
  • 5.Log-transformed 28 day SGTC rate for all SGTCs collected during the double blind maintenance treatment phase.(Screening to Week 15)
  • 6.SGTC responder rate.(Screening to Week 15)
  • 7.Changes from baseline in the anxiety and depression subscale scores of the Hospital Anxiety and Depression Scale (HADS) scores.(Baseline to Week 14)
  • 8.Change from baseline in Medical Outcomes Study Sleep Scale (MOS Sleep Scale) subscale scores.(Baseline to Week 14)
  • 9.Global scores on the patient rated Benefit, Satisfaction, and Willingness to Continue Measure (BSW).(Baseline to Week 14)

Investigators

Sponsor Class
Pharmaceutical industry-Global

Study Sites (7)

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