Trials / Completed
CompletedNCT02961803
MD1003-AMN MD1003 in Adrenomyeloneuropathy
MD1003 in Adrenomyeloneuropathy : a Randomized Double Blind Placebo Controlled Study
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- MedDay Pharmaceuticals SA · Industry
- Sex
- Male
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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
Detailed description
AMN and progressive multiple sclerosis share some similarities including progressive spastic paraparesis and secondary energy failure leading to progressive axonal degeneration. Therefore, it was hypothesized that high doses of biotin might be efficient in patients with AMN.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MD1003 100 mg capsule | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-06-01
- Completion
- 2017-06-01
- First posted
- 2016-11-11
- Last updated
- 2017-10-09
Locations
4 sites across 3 countries: France, Germany, Spain
Source: ClinicalTrials.gov record NCT02961803. Inclusion in this directory is not an endorsement.