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

Study acronym: FB1006
StatusRecruiting
PhasePhase 4
Started2023-01-18
View on ClinicalTrials.gov ↗

Amendment history

2023-11-20
Study Status, Study Description, Arms and Interventions v2
Study description-22 characters
[...] phase is 24 weeks, using an open-label study design. FB1006 (Mirtazapine tablets) was approved by the National Medical Products Administration（NMPA）on June 21, 2021.
2023-08-09
Study Status, Study Description, Arms and Interventions, Contacts/Locations v1
Study description+113 characters
[...] second phase is 24 weeks, using an open-label study design. FB1006 (Mirtazapine tablets) was approved by the National Medical Products Administration（NMPA）on June 21, 2021.
Study sitescontacts updated at 1 of 1 site
2023-06-20
Original filing
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.
Trial Details
NCT Number NCT05923905
Lead Sponsor Peking University Third Hospital
Conditions Sporadic and Familial Amyotrophic Lateral Sclerosis
Enrollment 64 participants
Start Date 2023-01-18
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2023-11-22