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Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of Pittsburgh |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004431 |
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 |
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Trigeminal Neuralgia |
Drug: L-baclofen |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | June 1998 |
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 to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Pennsylvania | |
University of Pittsburgh School of Medicine | Recruiting |
Pittsburgh, Pennsylvania, United States, 15261 | |
Contact: Michael J Soso 412-648-1239 |
Study Chair: | Michael J. Soso | University of Pittsburgh |
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 |
neurologic and psychiatric disorders rare disease trigeminal neuralgia |
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 |
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 |