NCT01825395

Brief Summary

To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).

Trial Health

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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 22, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

First QC Date

March 22, 2013

Last Update Submit

September 28, 2021

Conditions

Lambert Eaton Myasthenic Syndrome

Interventions

3, 4-DiaminopyridineDRUG

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Lambert-Eaton Myasthenic Syndrome

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

Study Officials

  • Steven P Ringel, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 5, 2013

Last Updated

October 6, 2021

Record last verified: 2021-09

Locations

US(1)