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Once-A-Day Pregabalin For Partial Seizures

NCT01262677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2021-01-25

Study results available
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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.

Conditions

  • Partial Seizures
  • Epilepsies, Partial

Interventions

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

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)

DRUG

placebo

matched to the active drug

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-17
Primary Completion
2012-07-31
Completion
2012-08-01

Countries

  • United States
  • Argentina
  • Bosnia and Herzegovina
  • Bulgaria
  • Czechia
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Malaysia
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Serbia
  • Singapore
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01262677 on ClinicalTrials.gov