Back to resultsUse of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome (3 4-DAP)
Primary Purpose
Lambert Eaton Myasthenic Syndrome
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
3, 4-Diaminopyridine
Sponsored by
About this trial
This is an expanded access trial for Lambert Eaton Myasthenic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older,
- Diagnosed with LEMS,
- If female, have a negative pregnancy test, and
- If premenopausal, be willing to practice an effective form of birth control during the study,
- Tested and found by ECG not to have a prolonged QT syndrome,
- Agree to have a second ECG at the time of peak drug effect,
- Has understood and signed the Informed Consent.
Exclusion Criteria:
- Is known to have a sensitivity to 3, 4-DAP,
Has a history of:
- past or current seizures,
- cardiac arrhythmia,
- hepatic, renal or hematologic disease, or
- severe asthma,
- Is believed by the investigator to be unable to comply with the protocol.
Sites / Locations
- University of Colorado
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01825395
First Posted
March 22, 2013
Last Updated
September 28, 2021
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT01825395
Brief Title
Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome
Acronym
3 4-DAP
Official Title
Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Approved for marketing
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
Name of the Sponsor
University of Colorado, Denver
4. Oversight
5. Study Description
Brief Summary
To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).
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-Diaminopyridine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older,
Diagnosed with LEMS,
If female, have a negative pregnancy test, and
If premenopausal, be willing to practice an effective form of birth control during the study,
Tested and found by ECG not to have a prolonged QT syndrome,
Agree to have a second ECG at the time of peak drug effect,
Has understood and signed the Informed Consent.
Exclusion Criteria:
Is known to have a sensitivity to 3, 4-DAP,
Has a history of:
past or current seizures,
cardiac arrhythmia,
hepatic, renal or hematologic disease, or
severe asthma,
Is believed by the investigator to be unable to comply with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven P Ringel, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome
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