NCT03745820

A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)

A Phase 2, Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BIIB104 in Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive Impairment Associated With Schizophrenia

Interventions

Type	Name	Description
DRUG	BIIB104	Administered as specified in the treatment arm
OTHER	Placebo	Administered as specified in the treatment arm

Timeline

• Start date: 2018-11-15
• Primary completion: 2022-03-23
• Completion: 2022-04-07
• First posted: 2018-11-19
• Last updated: 2023-04-18
• Results posted: 2023-04-18

Locations

60 sites across 5 countries: United States, Germany, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study