A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics

NCT02953639 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BP39207
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 37

Brief Summary

This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score

  The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite T-score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher composite T-score represents lower impairment.

  Baseline up to Week 24

Secondary Outcomes (14)

• Change From Baseline to Week 24 in MCCB Cognitive Domain Scores

  Baseline up to Week 24

• Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score

  Baseline up to Week 24

• Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score

  Baseline up to Week 24

• Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores

  Baseline up to Week 24

• Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score

  Baseline up to Week 24

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.

Drug: Placebo

Basmisanil 80mg BID

EXPERIMENTAL

Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.

Drug: Basmisanil

Basmisanil 240mg BID

EXPERIMENTAL

Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.

Drug: Basmisanil

Interventions

Basmisanil DRUG

Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.

Basmisanil 240mg BID; Basmisanil 80mg BID

Placebo DRUG

Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia of any type utilizing the Mini International Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) direct clinical assessments, family informants and past medical records
• Evidence of stability of symptoms for 3 months at screening, that is, without hospitalizations for schizophrenia or increase in level of psychiatric care due to worsening of symptoms of schizophrenia
• Participants with schizophrenia clinical symptom severity defined by the following: hallucinatory behavior item score less than or equal to (\</=) 5 and a delusion item score \</= 5 of the PANSS
• Participants on a stable regimen of antipsychotic therapy for at least 3 months at screening and receiving no more than two antipsychotics

You may not qualify if:

• Participants with current DSM-5 diagnosis other than schizophrenia including bipolar disorder, schizoaffective disorder and major depressive disorder
• Clinically significant neurological illness or significant head trauma that affects cognitive function, in the judgment of the principal investigator
• Full scale intelligence quotient \</=65 on the Wechsler Abbreviated Scale of Intelligence at screening
• Positive result at screening for hepatitis B, hepatitis C, or human immunodeficiency virus-1 and 2
• Moderate to severe substance use disorder (other than nicotine or caffeine), as defined by the DSM-5, within the last 12 months
• Suicide attempt within 1 year or currently at risk of suicide in the opinion of the Investigator

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (37)

Woodland International Research Group Inc.

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest, LLC

Rogers, Arkansas, 72758, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

California Clinical Trials

Glendale, California, 91206, United States

Location

Alliance for Wellness, dba Alliance for Research

Long Beach, California, 90807, United States

Location

Synergy Clinical Research

National City, California, 91950, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94607, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

CNRI - Los Angeles, LLC

Pico Rivera, California, 90660, United States

Location

Artemis Institute for Clinical Research, LLC

San Diego, California, 92103, United States

Location

Collaborative Neuroscience Network Inc.

Torrance, California, 90502, United States

Location

Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic

New Haven, Connecticut, 06519, United States

Location

Vantage Clinical Trials

Largo, Florida, 33770, United States

Location

Innovative Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

Meridien Research

Maitland, Florida, 32751, United States

Location

University of Miami Dept of Psychiatry

Miami, Florida, 33136, United States

Location

Behavioral Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Community Clinical Research Center

Anderson, Indiana, 46060, United States

Location

Booker, J. Gary, MD, APMC

Shreveport, Louisiana, 71104-2136, United States

Location

Louisiana Clinical Research, LLC

Shreveport, Louisiana, 71115, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Boston Medical Center

Boston, Massachusetts, 02114, United States

Location

Arch Clinical Trials, LLC

St Louis, Missouri, 63118, United States

Location

St Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Manhattan Psychiatric Center; Psychopharmacology Research Unit

New York, New York, 10035, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Pillar Clinical Research LLC

Garland, Texas, 75042, United States

Location

University Hills Clinical Research - Irving;Office of Dr. Knesevich

Irving, Texas, 75062, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

basmisanil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

Following a planned futility analysis, enrolment into the 80mg Basmisanil arm was discontinued as of 8th November 2018. Results from the 80mg Basmisanil arm are thus not presented.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 3, 2016
• Study Start: November 30, 2016
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: February 9, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (37)