Not Signed In -
Absence seizure |
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Clinical Trial: Pregabalin Epilepsy Add-On Trial
This study is not yet open for patient recruitment.
Verified by Pfizer August 2005
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Purpose
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 parital seizures
| Condition | Intervention | Phase |
|---|---|---|
| Partial seizure with or without secondary generalization | Drug: Administration | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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
Further Study Details:
Primary Outcomes: Response ratio (RRatio or symmetrized percent change) for all partial seizures
Secondary Outcomes: 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
Expected Total Enrollment: 177
Secondary Outcomes: 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
Expected Total Enrollment: 177
Study start: August 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Have a diagnosis of epilepsy with partial seizures (as defiend in the ILAE Clssification of Seizures) and be currently taking 1-3 AEDs
- Have a minimum of 4 partial seizures ocurring 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)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00141258
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A0081079
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00141258
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00141258
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
ClinicalTrials.gov processed this record on 2005-09-06
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