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

Trigeminal Neuralgia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004431
• Other study ID #: 199/13391
• Secondary ID: UPSOM-950686-960
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: June 1998
• Est. completion date: September 1999

Study information

• Verified date: April 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Idiopathic trigeminal neuralgia - Paroxysmal attacks of facial or frontal pain lasting a few seconds to less than 2 minutes - Pain has at least 4 of the following characteristics: Distribution along one or more divisions of the trigeminal nerve Sudden, intense, sharp, superficial, stabbing, or burning quality Pain intensity severe Precipitation from trigger areas, or by certain daily activities such as eating, talking, washing the face, or cleaning the teeth Between paroxysms entirely asymptomatic - No neurological deficit - Attacks are stereotyped in the individual patient - Exclusion of other causes of facial pain by history, physical examination and special investigations when necessary Must be uncontrolled or refractory as defined by occurrence of at least 2 paroxysms of pain per day despite conventional treatment with maximally tolerated doses of carbamazepine --Prior/Concurrent Therapy-- No concurrent medication for trigeminal neuralgia other than carbamazepine, phenytoin, and neurontin Concurrent medication for other conditions allowed Concurrent medication must be on stable dose(s) --Patient Characteristics-- Hepatic: No significant hepatic disease Renal: No significant renal disease Neurological: No evidence of progressing neurological disorder (e.g., intracranial neoplasm, multiple sclerosis) Other: No history of drug abuse Not pregnant Effective contraception required of all fertile patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• L-baclofen

Locations

Country	Name	City	State
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States,