NCT00872950

Brief Summary

The purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
Last Updated

April 11, 2022

Status Verified

March 1, 2022

First QC Date

March 30, 2009

Last Update Submit

March 24, 2022

Conditions

Keywords

LEMSCMS3,4 DIAMINOPYRIDINE3,4 DAP

Interventions

Treatment will begin with a low dose and will be increased as clinically needed as tolerated. The upper limit will be a total of 100mg/day.

Also known as: 3,4 DAP

Eligibility Criteria

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

You may qualify if:

  • LEMS diagnosis OR Pre or Post Synaptic CMS diagnosis
  • years or older
  • Females must have negative pregnancy test and be willing to practice an effective form of birth control
  • No prolonged QT syndrome as indicated by baseline EKG

You may not qualify if:

  • Known sensitivity to 3,4-DIAMINOPYRIDINE
  • History of seizures and/or severe asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Related Links

MeSH Terms

Conditions

Lambert-Eaton Myasthenic SyndromeMyasthenic Syndromes, Congenital

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 DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

4-AminopyridineAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jayashri Srinivasan, MD,MCRP,PhD

    Lahey Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2009

First Posted

April 1, 2009

Last Updated

April 11, 2022

Record last verified: 2022-03

Locations