Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
Recruitment status was Recruiting
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004431
|United States, Pennsylvania|
|University of Pittsburgh School of Medicine||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Michael J Soso 412-648-1239|
|Study Chair:||Michael J. Soso||University of Pittsburgh|