Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome

Lambert-Eaton Myasthenic Syndrome Clinical Trial

— 34-DAP  

Official title:

Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01373333
• Other study ID #: 102,384
• Status: No longer available
• Phase: N/A
• First received: June 13, 2011
• Last updated: July 18, 2016
• Start date: September 1997

Study information

• Verified date: July 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with LEMS and hopefully will decrease the need for prednisone and all other therapies that were previously required to control symptoms. How long a patient will take 3,4 DAP depends upon if he/she is seeing benefits from the medication or experiencing side effects that will prevent them from continuation in the study.

Description:

3,4-diaminopyridine (3,4-DAP) decreases symptoms of weakness in patients with LEMS, and therefore can be used to decrease the amount of immune modulation therapy needed to provide an equivalent degree of disease control.

Other known NCT identifiers

• NCT00817856

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of LEMS with or without any of the following: evidence of underlying malignancy, presence of P/Q or N-type calcium channel antibodies, electrodiagnostic evidence of a presynaptic defect of neuromuscular junction transmission.None of these laboratory findings are required for inclusion in this study.

2. P/Q and N type calcium channel antibodies are measured in the blood as a routine laboratory test during the course of initial diagnosis, but 10-20% of patients with LEMS do not have elevated levels of these antibodies.

Exclusion Criteria:

1. Hypersensitivity to any component of this medication.

2. History of past or current seizures.

3. History of asthma.

4. Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the QTc interval.

5. Family history of prolonged QTc syndrome, history of unexplained syncope, seizures or cardiac arrest.

Study Design

N/A

Related Conditions & MeSH terms

• Lambert-Eaton Myasthenic Syndrome
• Syndrome

Intervention

Drug:
• 3,4 DAP
Recommended maximum dosage: 20mg four times daily and if needed an additional 20 mg per day for a total of 100 mg per day. Drug must be kept refrigerated at all times.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States,