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	Treatment or Intervention
Trigeminal Neuralgia	Drug: L-baclofen

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.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Pennsylvania
      University of Pittsburgh School of Medicine, Pittsburgh,  Pennsylvania,  15261,  United States; Recruiting

Study chairs or principal investigators

Michael J. Soso,  Study Chair,  University of Pittsburgh   

Study ID Numbers:  199/13391; UPSOM-950686-9608; UPSOM-FDR000914
Record last reviewed:  April 2000
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004431
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09