- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00704925
Treatment of Lambert-Eaton Syndrome With 3,4 DAP
Treatment of Lambert-Eaton Syndrome With 3, 4-Diaminopyridine
A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS). This is an expanded access trial, which means that although data from this study will be collected and reported to the US Food and Drug Administration (FDA)and the drug manufacturer, this is not a formal study of drug in LEMS.
If you decide volunteer, you will be evaluated by a neurologist to determine your eligibility to receive 3, 4-DAP by a review of your medical history, medication regimen (the medications you are taking) and a neurological examination. If you are a female of child-bearing potential, a serum pregnancy test will be done to ensure that you are not pregnant. Once it is determined that this treatment is appropriate for your care, you will begin taking 3, 4 DAP by mouth in slowly increasing doses. Treatment will begin with 5mg three times a day, as clinically needed, and if tolerated. You will be monitored for strength and side effects by routine clinic visits at initial intervals of once a month, increasing to intervals of every 12 months as permitted. Blood will be drawn (approximately 1 tablespoon) at every clinic visit or as often as the investigator deems necessary to assess your liver/kidney function and blood counts. You will have an EKG (a test to see how your heart is functioning) at your first study visit, after 6 months of taking 3,4 DAP and again every 2 years. Treatment will be continued indefinitely if a good clinical response is achieved. This study is planned to last indefinitely.
The dosage of 3, 4DAP is individually adjusted. The usual range is 10-15 mg 3-4 times per day for the full effect and will increase by 50% every two weeks to 10-15 mg three to six times a day, as needed and if tolerated. Dosages above the full effect level will not provide an additional benefit and should not be used. 3, 4 DAP is a convulsant (causes seizures). A total of 100 mg/day is the maximum dosage allowed.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- University of California, Davis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be 18 years or older, diagnosed with LEMS
- If female, have negative pregnancy test and if premenopausal, be willing to practice an effective form of birth control during the study.
Exclusion Criteria:
- Is known to have a sensitivity to 3, 4 DAP
- Has a history of past or current seizures
- Has a history of past or current severe asthma
- Is believed by the investigator to be unable to comply with the protocol
- Unable to give informed consent
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Disease
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Myasthenia Gravis
- Syndrome
- Lambert-Eaton Myasthenic Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Membrane Transport Modulators
- Neuromuscular Agents
- Potassium Channel Blockers
- Amifampridine
Other Study ID Numbers
- 200311036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lambert Eaton Myasthenic Syndrome
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Catalyst Pharmaceuticals, Inc.CompletedA Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)Lambert Eaton Myasthenic SyndromeUnited States, Spain, Serbia, Russian Federation, Hungary, France, Germany, Poland
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University of Colorado, DenverApproved for marketingLambert Eaton Myasthenic SyndromeUnited States
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Jacobus PharmaceuticalCompletedLambert-Eaton Myasthenic Syndrome | Eaton-Lambert Myasthenic SyndromeUnited States
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Louis H. Weimer, MDNo longer availableLambert Eaton Myasthenic Syndrome (LEMS)United States
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Oregon Health and Science UniversityJacobus PharmaceuticalNo longer availableLambert-Eaton Myasthenic Syndrome (LEMS) | Congenital Myasthenia (CM)United States
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argenxRecruitingCongenital Myasthenic SyndromeUnited States, Canada, France
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Catalyst Pharmaceuticals, Inc.CompletedMyasthenic Syndromes, CongenitalUnited States
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Ricardo MaselliCatalyst Pharmaceuticals, Inc.No longer availableCongenital Myasthenic SyndromeUnited States
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Mayo ClinicCompletedCongenital Myasthenic SyndromeUnited States
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Institut de Myologie, FranceAssistance Publique - Hôpitaux de ParisCompletedCongenital Myasthenic Syndrome
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