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NCT00994916 Clinical Trial

Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Lambert-Eaton Myasthenic Syndrome Clinical Trial

Official title:
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00994916
Other study ID # IRB0410047
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date July 2019
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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).

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Diagnosis of LEMS

2. Over 18 years old

3. Medically stable

4. 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:

1. Known sensitivity to 3,4 DAP

2. History of past or current seizures

3. History of severe asthma

4. Believed by the investigator to be unable to comply with the protocol

5. Unable to provide informed consent

Study Design

Related Conditions & MeSH terms

  • Lambert-Eaton Myasthenic Syndrome
  • Syndrome

Intervention

Drug:
• 3,4 diaminopyridine
3,4 diaminopyridine up to 80 mg daily in divided doses

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
David Lacomis, MD Jacobus Pharmaceutical
See also
  Status Clinical Trial Phase
No longer available NCT01373333 - Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome N/A
Completed NCT02970162 - Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS) Phase 3
Completed NCT05408702 - Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes
Recruiting NCT06441825 - Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
Completed NCT01511978 - Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome Phase 2
Completed NCT00004832 - Randomized Study of 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome N/A
Approved for marketing NCT00872950 - 3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)
No longer available NCT02189720 - Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome