NCT05923905

Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients.

Detailed description

This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients. The study has two phases: the first phase is 24 weeks, using a randomized double-blind placebo-controlled design; the second phase is 24 weeks, using an open-label study design. FB1006 was approved by the National Medical Products Administration（NMPA）on June 21, 2021.

Conditions

• Sporadic and Familial Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	FB1006	30mg/day
DRUG	Placebo	30mg/day

Timeline

• Start date: 2023-01-18
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-06-28
• Last updated: 2023-11-22

Locations

1 site across 1 country: China