CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
BIIB104 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03745820
NCT03745820Phase 2Completed
CompareCT.gov

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)

Biogen·interventional·Posted Nov 19, 2018·Updated Apr 18, 2023

In Brief

A Phase 2 clinical trial evaluating BIIB104 and Placebo for Cognitive Impairment Associated With Schizophrenia. Completed, enrolled 195 participants across 60 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCognitive Impairment Associated With Schizophrenia
CountriesGermany, Japan, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 19, 2018
Enrollment StartNov 15, 2018
Primary CompletionMar 23, 2022
Study CompletionApr 7, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.6 years ago

Interventions

BIIB104drug

Administered as specified in the treatment arm

Placeboother

Administered as specified in the treatment arm