Once-A-Day Pregabalin For Partial Seizures

Completed · Phase 3 · Has a placebo group

Conditions studied: Partial Seizures, Epilepsies, Partial

In brief

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.

Key facts

Study ID

NCT01262677

Run by

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

People needed

325

Starts

2011-02-17

Expected to finish

2012-08-01

Last updated by the study team

2021-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• Collaborative Neuroscience Network, Inc. — Long Beach, California, United States
• Viking Clinic Research Center — Murrieta, California, United States
• Viking Clinical Research Center — Murrieta, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Viking Clinical Research Center — Temecula, California, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Optima Neurological Services, LLC — Gainesville, Florida, United States
• Sleep Disorders Center of Georgia - Gainesville — Gainesville, Georgia, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• VCMA Comprehensive Epilepsy Center — Wichita, Kansas, United States
• Via Christi Research — Wichita, Kansas, United States
• Associates in Neurology, PSC — Lexington, Kentucky, United States
• Mid Atlantic Headache Institute — Pikesville, Maryland, United States
• Asheville Neurology Specialists, PA — Asheville, North Carolina, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Mark A. Fisher, M.D.- Private Practice — Oklahoma City, Oklahoma, United States
• Sooner Clinical Research — Oklahoma City, Oklahoma, United States
• Veroniqe Sebastian, MD — Oklahoma City, Oklahoma, United States
• Angelique Barreto, MD — Oklahoma City, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States
• Scott and White Healthcare-Office of Sponsored Research Administration — Temple, Texas, United States
• Neurology Clinic, PC — Northport, Alabama, United States

Full record on ClinicalTrials.gov

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