- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00141258
Pregabalin Epilepsy Add-On Trial
January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pregabalin Add-On Titration Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Partial Seizures
To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures
Study Overview
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Daegu, Korea, Republic of
- Pfizer Investigational Site
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Daejeon, Korea, Republic of
- Pfizer Investigational Site
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Gwangju, Korea, Republic of
- Pfizer Investigational Site
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Incheon, Korea, Republic of
- Pfizer Investigational Site
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Seoul, Korea, Republic of
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs
- Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures
Exclusion Criteria:
- Have a treatable cause of seizures
- Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Response ratio (RRatio or symmetrized percent change) for all partial seizures
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Secondary Outcome Measures
Outcome Measure |
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Responder rate, Percent change, Percent of SGTC responders, Seizure freedom measures, Change in number of seizure-free days (SFD) per a 28-day period, Analysis by seizure type, HADS, Weekly and endpoint mean sleep interference scores from DSIS, QOLIE-31
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Actual)
January 22, 2021
Last Update Submitted That Met QC Criteria
January 21, 2021
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Seizures
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- A0081079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Partial Seizures
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ValexfarmCompletedEpilepsy | Complex Partial Seizures | Simple Partial Seizures | Partial Seizures With Secondary GeneralizationRussian Federation
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NovartisCompletedEpilepsy, Partial SeizuresRussian Federation
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NovartisCompletedEpilepsy, Partial SeizuresRussian Federation
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Lundbeck LLCCompletedAdult Refractory Complex Partial SeizuresUnited States
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UCB PharmaCompletedPartial EpilepsiesUnited States, Poland, United Kingdom, Switzerland, Hungary, Germany, Sweden, Lithuania
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UCB BIOSCIENCES, Inc.CompletedPartial Epilepsies | Partial Onset SeizuresUnited States
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Bial - Portela C S.A.CompletedEfficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial SeizuresRefractory Partial EpilepsyPortugal
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UCB BIOSCIENCES, Inc.CompletedPartial Epilepsies | Partial Onset SeizuresUnited States
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Bial - Portela C S.A.SunovionCompletedPartial EpilepsyUnited States, Argentina, Germany, France, Belgium, Canada, Italy, Poland, Greece, Brazil, Cyprus
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