Back to resultsUse Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome (34-DAP)
Primary Purpose
Lambert-Eaton Myasthenic Syndrome
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
3,4 DAP
Sponsored by
About this trial
This is an expanded access trial for Lambert-Eaton Myasthenic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of LEMS with or without any of the following: evidence of underlying malignancy, presence of P/Q or N-type calcium channel antibodies, electrodiagnostic evidence of a presynaptic defect of neuromuscular junction transmission.None of these laboratory findings are required for inclusion in this study.
- P/Q and N type calcium channel antibodies are measured in the blood as a routine laboratory test during the course of initial diagnosis, but 10-20% of patients with LEMS do not have elevated levels of these antibodies.
Exclusion Criteria:
- Hypersensitivity to any component of this medication.
- History of past or current seizures.
- History of asthma.
- Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the QTc interval.
- Family history of prolonged QTc syndrome, history of unexplained syncope, seizures or cardiac arrest.
Sites / Locations
- Cleveland Clinic Foundation
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01373333
Brief Title
Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome
Acronym
34-DAP
Official Title
Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
No longer available
Study Start Date
September 1997 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
5. Study Description
Brief Summary
Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with LEMS and hopefully will decrease the need for prednisone and all other therapies that were previously required to control symptoms. How long a patient will take 3,4 DAP depends upon if he/she is seeing benefits from the medication or experiencing side effects that will prevent them from continuation in the study.
Detailed Description
3,4-diaminopyridine (3,4-DAP) decreases symptoms of weakness in patients with LEMS, and therefore can be used to decrease the amount of immune modulation therapy needed to provide an equivalent degree of disease control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lambert-Eaton Myasthenic Syndrome
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
3,4 DAP
Intervention Description
Recommended maximum dosage: 20mg four times daily and if needed an additional 20 mg per day for a total of 100 mg per day. Drug must be kept refrigerated at all times.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of LEMS with or without any of the following: evidence of underlying malignancy, presence of P/Q or N-type calcium channel antibodies, electrodiagnostic evidence of a presynaptic defect of neuromuscular junction transmission.None of these laboratory findings are required for inclusion in this study.
P/Q and N type calcium channel antibodies are measured in the blood as a routine laboratory test during the course of initial diagnosis, but 10-20% of patients with LEMS do not have elevated levels of these antibodies.
Exclusion Criteria:
Hypersensitivity to any component of this medication.
History of past or current seizures.
History of asthma.
Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the QTc interval.
Family history of prolonged QTc syndrome, history of unexplained syncope, seizures or cardiac arrest.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry H Levin, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44139
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome
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