Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal neuralgia.
II. Evaluate the safety and tolerance of L-baclofen in these patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Study Start Date:||June 1998|
|Estimated Study Completion Date:||September 1999|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, parallel study.
Patients are randomized to receive either L-baclofen or placebo orally at increasing daily doses for 1 week. Patients then continue to receive the maximum dosage acceptable for a 1 week maintenance period.
Patients, thereafter, may enroll in a long term open label study with L-baclofen.
Patients are followed at 1, 3, 6, 9, and 12 months.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004431
|United States, Pennsylvania|
|University of Pittsburgh School of Medicine|
|Pittsburgh, Pennsylvania, United States, 15261|
|Study Chair:||Michael J. Soso||University of Pittsburgh|