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

This study is currently recruiting participants.

Verified by Lahey Clinic, March 2009

First Received: March 30, 2009 Last Updated: March 31, 2009 History of Changes

Sponsored by:	Lahey Clinic
Information provided by:	Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00872950

Purpose

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).

Condition	Intervention
Lambert-Eaton Myasthenic Syndrome	Drug: 3,4-DIAMINOPYRIDINE

Drug Information available for: 3,4-Diaminopyridine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS)

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:

Increase in strength and autonomic symptoms [ Time Frame: 1-10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	4
Study Start Date:	June 2001
Estimated Study Completion Date:	June 2020
Estimated Primary Completion Date:	June 2020 (Final data collection date for primary outcome measure)

Intervention Details:

Treatment will begin with 5 mg three times a day. A common final dosage is 15 mg 4 or 5 times a day as clinically needed if tolerated. The upper limit will be a total of 100mg/day.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

LEMS 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872950

Contacts

Contact: Alyssa B DeThomas, BSN	781-744-2958	alyssa.b.dethomas@lahey.org
Contact: Stephanie A Scala, MA	781-744-2950	stephanie.a.scala@lahey.org

Locations

United States, Massachusetts
Lahey Clinic	Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Alyssa B DeThomas, BSN 781-744-2958 alyssa.b.dethomas@lahey.org
Contact: Stephanie A Scala, MA 781-744-2950 stephanie.a.scala@lahey.org

Sponsors and Collaborators

Lahey Clinic

Investigators

Principal Investigator:

H. Royden Jones, MD

Lahey Clinic

More Information

No publications provided

Responsible Party:	Lahey Clinic ( H. Royden Jones MD )
Study ID Numbers:	2001-040
Study First Received:	March 30, 2009
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00872950 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lahey Clinic:

LEMS
3,4-DIAMINOPYRIDINE

Study placed in the following topic categories:

Autoimmune Diseases
Paraneoplastic Syndromes
Neuromuscular Diseases
Potassium Channel Blockers
3,4-diaminopyridine
4-Aminopyridine

Lambert-Eaton Myasthenic Syndrome
Cardiovascular Agents
Neurodegenerative Diseases
Paraneoplastic Syndromes, Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Neoplasms

Additional relevant MeSH terms:

Disease
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Nervous System Diseases
3,4-diaminopyridine
Lambert-Eaton Myasthenic Syndrome
Cardiovascular Agents
Neurodegenerative Diseases
Pharmacologic Actions
Membrane Transport Modulators
Neoplasms

Pathologic Processes
Neoplasms by Site
Paraneoplastic Syndromes
Neuromuscular Diseases
Therapeutic Uses
Syndrome
Potassium Channel Blockers
Neuromuscular Junction Diseases
4-Aminopyridine
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009