NCT00994916

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).

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

First QC Date

October 8, 2009

Last Update Submit

July 5, 2019

Conditions

Lambert-Eaton Myasthenic Syndrome

Keywords

Lambert-Eaton myasthenic syndrome3,4 diaminopyridine

Interventions

3,4 diaminopyridineDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lambert-Eaton Myasthenic Syndrome

Interventions

Amifampridine

Condition Hierarchy (Ancestors)

Myasthenia GravisParaneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

4-AminopyridineAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Neurology and Pathology

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 14, 2009

Last Updated

July 9, 2019

Record last verified: 2019-07