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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

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

18 Years - undefined (Adult, Older Adult)All Sexes

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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