ClinicalTrials.gg
CompletedNCT00004939Updated Jun 24, 2005

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

A Phase 3 interventional study of ,4-diaminopyridine in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by National Center for Research Resources (NCRR). Completed. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Center for Research Resources (NCRR) · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

OBJECTIVES:

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

Read the 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.

02

Conditions studied

  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Keywords

  • demyelinating neuropathy
  • neurologic and psychiatric disorders
  • rare disease
03

In context

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.

This study's enrollment of 34 is close to the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Lead sponsor

National Center for Research Resources (NCRR) is the lead sponsor of 265 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinical diagnosis of demyelinating neuropathy, i.e.: Hereditary motor and sensory neuropathy type I Chronic inflammatory demyelinating polyneuropathy meeting American Academy of Neurology AIDS Task Force criteria Multifocal motor neuropathy and conduction block Clinically stable for at least 6 months prior to entry --Prior/Concurrent Therapy-- At least 6 months since change in dose --Patient Characteristics-- Age: 20 to 80 Hepatic: No predisposition to hepatic disease Renal: No predisposition to renal disease Cardiovascular: No predisposition to cardiac disease Other: No other medical condition affecting neuropathy or study evaluation No predisposition to seizures

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
Double
Enrollment
34 participants

Interventions

  • Drug,4-diaminopyridine
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Russell JW, Windebank AJ, Harper CM Jr. Treatment of stable chronic demyelinating polyneuropathy with 3,4-diaminopyridine. Mayo Clin Proc. 1995 Jun;70(6):532-9. doi: 10.4065/70.6.532. PubMed 7776711 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 1996 and a completion of Aug 1996. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2000
First posted
Feb 25, 2000
Start
Aug 1996
Completion
Aug 1996
Last update
Jun 24, 2005
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00004939
Collaborators
Mayo Clinic
First posted
Feb 25, 2000
Start date
Aug 1996
Completion
Aug 1996
Last update
Jun 24, 2005

Study contacts

Anthony J. Windebank
study chair · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2001. You cannot join it, but the record below documents what was studied.

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