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MD1003-AMN MD1003 in Adrenomyeloneuropathy

NCT02961803 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2017-10-09

No results posted yet for this study

Summary

The primary objective of the trial is to demonstrate the superiority of biotin at 300 mg/day over placebo in the clinical improvement (walking tests) of patients with adrenomyeloneuropathy

Conditions

  • Adrenomyeloneuropathy
  • Adrenoleukodystrophy
  • AMN

Interventions

DRUG

MD1003 100 mg capsule

DRUG

Placebo

Sponsors & Collaborators

  • MedDay Pharmaceuticals SA

    lead INDUSTRY

Principal Investigators

  • Patrick Aubourg, MD · Hopital Le Kremlin-Bicêtre

  • Frederic Sedel, MD · Medday Pharmeuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-06-30
Completion
2017-06-30

Countries

  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02961803 on ClinicalTrials.gov