NCT00004431

Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	L-baclofen

Timeline

• Start date: 1998-06-01
• Completion: 1999-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States