Trial record 7 of 52 for:
Paraneoplastic Syndromes
3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)
This study is currently recruiting participants.
Verified September 2011 by Lahey Clinic
Sponsor:
Lahey Clinic
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00872950
First received: March 30, 2009
Last updated: September 29, 2011
Last verified: September 2011
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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) and Congenital Myasthenic Syndromes (CMS).
| Condition | Intervention |
|---|---|
|
Lambert-Eaton Myasthenic Syndrome Congenital Myasthenic Syndrome |
Drug: 3,4-DIAMINOPYRIDINE |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS) |
Resource links provided by NLM:
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: | 25 |
| 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:
-
Drug: 3,4-DIAMINOPYRIDINE
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.
Other Name: 3,4 DAP
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872950
Contacts
| Contact: Lynn A Sullivan | 781-744-2958 | Lynn.A.Sullivan@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: Lynn A Sullivan 781-744-2958 lynn.a.sullivan@lahey.org | |
| Contact: Stephanie A Scala, MA 781-744-2950 stephanie.a.scala@lahey.org | |
Sponsors and Collaborators
Lahey Clinic
Investigators
| Principal Investigator: | Jayashri Srinivasan, MD, MCRP, PhD | Lahey Clinic |
| Study Director: | H. Royden Jones, MD | Lahey Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lahey Clinic |
| ClinicalTrials.gov Identifier: | NCT00872950 History of Changes |
| Other Study ID Numbers: | 2001-040 |
| Study First Received: | March 30, 2009 |
| Last Updated: | September 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Lahey Clinic:
|
LEMS CMS 3,4 DIAMINOPYRIDINE 3,4 DAP |
Additional relevant MeSH terms:
|
Lambert-Eaton Myasthenic Syndrome Myasthenic Syndromes, Congenital Paraneoplastic Syndromes, Nervous System Paraneoplastic Syndromes Nervous System Neoplasms Neoplasms by Site Neoplasms Autoimmune Diseases of the Nervous System Nervous System Diseases Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases |
Autoimmune Diseases Immune System Diseases Genetic Diseases, Inborn 3,4-diaminopyridine 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013