Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
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|ClinicalTrials.gov Identifier: NCT00004431|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuralgia||Drug: L-baclofen||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||June 1998|
|Study Completion Date :||September 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004431
|United States, Pennsylvania|
|University of Pittsburgh School of Medicine|
|Pittsburgh, Pennsylvania, United States, 15261|
|Study Chair:||Michael J. Soso||University of Pittsburgh|