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

NCT ID: NCT00004431

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30
• Study Completion Date: 1999-09-30

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

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

L-baclofen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Principal Investigators

Michael J. Soso

Role: STUDY_CHAIR

University of Pittsburgh

Locations

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

UPSOM-950686-9608

Identifier Type: -

Identifier Source: secondary_id

UPSOM-FDR000914

Identifier Type: -

Identifier Source: secondary_id

199/13391

Identifier Type: -

Identifier Source: org_study_id