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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Duke University |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004832 |
OBJECTIVES: I. Evaluate the safety and effectiveness of 3,4-diaminopyridine (DAP) in the treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS). II. Determine the side-effects and benefits associated with DAP.
Condition | Intervention |
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Lambert-Eaton Myasthenic Syndrome |
Drug: 3,4-diaminopyridine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 26 |
Study Start Date: | August 1994 |
Estimated Study Completion Date: | June 1998 |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to receive 3,4-diaminopyridine (DAP) or placebo orally 3 times daily for 5 days, after which treatment is discontinued and patients are observed for at least 24 hours. At the end of the blinded study, patients may then elect to take open label DAP orally 3 times daily for 6 months; those who do so are monitored for clinical effects and side effects for at least 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Lambert-Eaton myasthenic syndrome (LEMS) based on weakness that predominates in proximal limb muscles and electromyography (EMG) findings of small amplitude muscle responses to nerve stimulation, which decrease further during nerve stimulation at 5 Hz and which increase at least 2-fold after maximum voluntary contraction of the muscle for 10-20 seconds Quantified Myasthenia Gravis (QMG) clinical score at least 5 --Prior/Concurrent Therapy-- Chemotherapy: No concurrent chemotherapy Endocrine therapy: Patients receiving immunosuppressants must be on the same dose of medication for at least 3 months prior to study entry Radiotherapy: No concurrent radiotherapy Surgery: No concurrent surgery Other: Patients receiving cholinesterase inhibitors must discontinue the medication at study entry if possible, or else be on the same dose of medication for at least 1 month prior to study entry --Patient Characteristics-- Hematopoietic: No significant hematologic disease Hepatic: No significant hepatic disease Renal: No significant renal disease Cardiovascular: No cardiac arrhythmia or significant cardiac disease Neurologic: No seizure disorder Other: Not pregnant Negative pregnancy test required of fertile women Effective contraception required of fertile women
Study ID Numbers: | 199/13441, DUMC-577, DUMC-FDR001068 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004832 History of Changes |
Health Authority: | United States: Federal Government |
Lambert-Eaton myasthenic syndrome neurologic and psychiatric disorders rare disease |
Autoimmune Diseases Rare Diseases 3,4-diaminopyridine Lambert-Eaton Myasthenic Syndrome Cardiovascular Agents Neurodegenerative Diseases Paraneoplastic Syndromes |
Neuromuscular Diseases Mental Disorders Potassium Channel Blockers 4-Aminopyridine Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Autoimmune Diseases of the Nervous System |
Disease Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Nervous System Diseases 3,4-diaminopyridine Lambert-Eaton Myasthenic Syndrome Cardiovascular Agents Neurodegenerative Diseases Pharmacologic Actions Membrane Transport Modulators Neoplasms |
Pathologic Processes Neoplasms by Site Paraneoplastic Syndromes Neuromuscular Diseases Therapeutic Uses Syndrome Potassium Channel Blockers Neuromuscular Junction Diseases 4-Aminopyridine Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Autoimmune Diseases of the Nervous System |