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Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome

NCT01511978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-07-11

Study results available
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Summary

Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome (LEMS)-related weakness.

Conditions

  • Lambert-Eaton Myasthenic Syndrome
  • Eaton-Lambert Myasthenic Syndrome

Interventions

DRUG

Continuous 3,4-DAP

Subjects were maintained on their usual personal dose and schedule of 3,4-DAP base

DRUG

Taper 3,4-DAP to Placebo

Subjects were tapered over 3 days from their usual regimen of 3,4-DAP base to placebo with up to an additional 16 hours of placebo before resuming their usual pre-study regimen of 3,4-DAP base

Sponsors & Collaborators

  • Jacobus Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Kathy L Aleš, MD · Jacobus Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-02-28
Completion
2015-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511978 on ClinicalTrials.gov