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Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, April 2000
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: FDA Office of Orphan Products Development
University of Pittsburgh
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00004431
  Purpose

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 Intervention
Trigeminal Neuralgia
Drug: L-baclofen

MedlinePlus related topics: Trigeminal Neuralgia
Drug Information available for: Baclofen
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 30
Study Start Date: June 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004431

Locations
United States, Pennsylvania
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Michael J Soso     412-648-1239        
Sponsors and Collaborators
University of Pittsburgh
Investigators
Study Chair: Michael J. Soso University of Pittsburgh
  More Information

No publications provided

Study ID Numbers: 199/13391, UPSOM-950686-9608, UPSOM-FDR000914
Study First Received: October 18, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004431     History of Changes
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
neurologic and psychiatric disorders
rare disease
trigeminal neuralgia

Study placed in the following topic categories:
Neurotransmitter Agents
Neuralgia
Baclofen
Rare Diseases
Pain
Signs and Symptoms
Neuromuscular Diseases
Mental Disorders
Peripheral Nervous System Diseases
Muscle Relaxants, Central
GABA Agonists
Neurologic Manifestations
Peripheral Nervous System Agents
Trigeminal Neuralgia

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuralgia
Nervous System Diseases
Baclofen
Physiological Effects of Drugs
Neuromuscular Agents
Pain
Pharmacologic Actions
Signs and Symptoms
Neuromuscular Diseases
GABA Agonists
Therapeutic Uses
Peripheral Nervous System Diseases
Muscle Relaxants, Central
GABA Agents
Neurologic Manifestations
Trigeminal Nerve Diseases
Peripheral Nervous System Agents
Cranial Nerve Diseases
Central Nervous System Agents
Trigeminal Neuralgia

ClinicalTrials.gov processed this record on May 07, 2009