NCT00004939

Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating polyneuropathy.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days. After a washout of at least 5 days, patients cross to the alternate therapy for 4 days.

Conditions

• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Type	Name	Description
DRUG	,4-diaminopyridine

Timeline

• Start date: 1996-08-01
• Completion: 1996-08-01
• First posted: 2000-02-25
• Last updated: 2005-06-24