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Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS)


N/A
18 Years
N/A
Open (Enrolling)
Both
Lambert-Eaton Myasthenic Syndrome, Congenital Myasthenic Syndrome

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Trial Information

Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS)


Inclusion Criteria:



- LEMS diagnosis OR Pre or Post Synaptic CMS diagnosis

- 18 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

Exclusion Criteria:

- Known sensitivity to 3,4-DIAMINOPYRIDINE

- History of seizures and/or severe asthma

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Increase in strength and autonomic symptoms

Outcome Time Frame:

1-10 years

Safety Issue:

Yes

Principal Investigator

Jayashri Srinivasan, MD, MCRP, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lahey Clinic

Authority:

United States: Food and Drug Administration

Study ID:

2001-040

NCT ID:

NCT00872950

Start Date:

June 2001

Completion Date:

June 2020

Related Keywords:

  • Lambert-Eaton Myasthenic Syndrome
  • Congenital Myasthenic Syndrome
  • LEMS
  • CMS
  • 3,4 DIAMINOPYRIDINE
  • 3,4 DAP
  • Lambert-Eaton Myasthenic Syndrome
  • Myasthenic Syndromes, Congenital

Name

Location

Lahey ClinicBurlington, Massachusetts  01805