A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
Summary
The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB). The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104 in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS on measures of cognition, functioning, and psychiatric symptomology.
Timeline
- Start
- 2018-11-15
- Primary completion
- 2022-03-23
- Completion
- 2022-04-07
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs BIIB104 0.15 mg; p =0.8472; Least Squares (LS) Mean Difference -0.26 (95% CI -2.88 to 2.37); MMRM NCT03745820 ↗
registry analysis (superiority test); Placebo vs BIIB104 0.5 mg; p =0.8053; LS Mean Difference -0.33 (95% CI -2.94 to 2.29); MMRM NCT03745820 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PESAMPATOR | Small molecule | 0.15 mg | Oral |
| Subject | PESAMPATOR | Small molecule | 0.5 mg | Oral |