Effect of MD1003 in Amyotrophic Lateral Sclerosis
NCT03114215 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-06-04
Summary
This is a 6-month double blind randomized 2:1 placebo-controlled study with two arms (placebo, biotin 300 mg/day). The study will be followed by a 6-month extension phase during which all patients will receive biotin 300 mg/day.
Conditions
- ALS
- Amyotrophic Lateral Sclerosis
- Motor Neuron Disease
Interventions
- DRUG
-
MD1003
capsules 100mg 3 times per day
- DRUG
-
Placebo oral capsule
capsules 100mg lactose 3 times per day
Sponsors & Collaborators
-
MedDay Pharmaceuticals SA
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-29
- Primary Completion
- 2017-06-12
- Completion
- 2017-12-31
Countries
- France
Study Locations
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