Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Primary Purpose
Lambert-Eaton Myasthenic Syndrome
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
3,4 diaminopyridine
Sponsored by
About this trial
This is an expanded access trial for Lambert-Eaton Myasthenic Syndrome focused on measuring Lambert-Eaton myasthenic syndrome, 3,4 diaminopyridine
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of LEMS
- Over 18 years old
- Medically stable
- If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study
Exclusion Criteria:
- Known sensitivity to 3,4 DAP
- History of past or current seizures
- History of severe asthma
- Believed by the investigator to be unable to comply with the protocol
- Unable to provide informed consent
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00994916
First Posted
October 8, 2009
Last Updated
July 5, 2019
Sponsor
David Lacomis, MD
Collaborators
Jacobus Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00994916
Brief Title
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Official Title
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Lacomis, MD
Collaborators
Jacobus Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).
Detailed Description
Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.
The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.
The investigator has a hold on enrolling new subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lambert-Eaton Myasthenic Syndrome
Keywords
Lambert-Eaton myasthenic syndrome, 3,4 diaminopyridine
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
3,4 diaminopyridine
Intervention Description
3,4 diaminopyridine up to 80 mg daily in divided doses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Diagnosis of LEMS
Over 18 years old
Medically stable
If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study
Exclusion Criteria:
Known sensitivity to 3,4 DAP
History of past or current seizures
History of severe asthma
Believed by the investigator to be unable to comply with the protocol
Unable to provide informed consent
12. IPD Sharing Statement
Learn more about this trial
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
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