NCT03114215

Effect of MD1003 in Amyotrophic Lateral Sclerosis

Effect of MD1003 in Amyotrophic Lateral Sclerosis: a Randomized Double Blind Placebo Controlled Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MedDay Pharmaceuticals SA · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	MD1003	capsules 100mg 3 times per day
DRUG	Placebo oral capsule	capsules 100mg lactose 3 times per day

Timeline

• Start date: 2016-06-29
• Primary completion: 2017-06-12
• Completion: 2017-12-01
• First posted: 2017-04-14
• Last updated: 2019-06-04

Locations

1 site across 1 country: France