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

Not Applicable

Completed

• Conditions: Trigeminal Neuralgia

• Registration Number: NCT00004431
• Lead Sponsor: University of Pittsburgh

Brief 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

Study Timeline

• Study Start: 1998-06
• Study Completion: 1999-09
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2000-04
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of Pittsburgh School of Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States