SchizophreniaPhase 2NCT02953639
A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
A Phase 2 study testing Basmisanil in people with Schizophrenia, run by Hoffmann-La Roche at 37 sites in United States.
Trial summary
This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Basmisanil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 37 sitesUnited States
- Study dates
- 30 Nov 2016to 12 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Community Clinical Research Center
Anderson, Indiana, 46060
Northwest Clinical Research Center
Bellevue, Washington, 98007
Hassman Research Institute
Berlin, New Jersey, 08009
Boston Medical Center
Boston, Massachusetts, 02114
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
University Hospitals
Cleveland, Ohio, 44106
ProScience Research Group
Culver City, California, 90230
Midwest Clinical Research Center
Dayton, Ohio, 45417
iResearch Atlanta
Decatur, Georgia, 30030
CBH Health
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Pillar Clinical Research LLC
Garland, Texas, 75042
California Clinical Trials
Glendale, California, 91206
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
University Hills Clinical Research - Irving;Office of Dr. Knesevich
Irving, Texas, 75062
Vantage Clinical Trials
Largo, Florida, 33770
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Woodland International Research Group Inc.
Little Rock, Arkansas, 72211
Alliance for Wellness, dba Alliance for Research
Long Beach, California, 90807
Meridien Research
Maitland, Florida, 32751
University of Miami Dept of Psychiatry
Miami, Florida, 33136
Synergy Clinical Research
National City, California, 91950
Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic
New Haven, Connecticut, 06519
Manhattan Psychiatric Center; Psychopharmacology Research Unit
New York, New York, 10035
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161
Pacific Research Partners, LLC
Oakland, California, 94607
NRC Research Institute
Orange, California, 92868
CNRI - Los Angeles, LLC
Pico Rivera, California, 90660
Finger Lakes Clinical Research
Rochester, New York, 14618
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758
Artemis Institute for Clinical Research, LLC
San Diego, California, 92103
Booker, J. Gary, MD, APMC
Shreveport, Louisiana, 71104-2136
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71115
Arch Clinical Trials, LLC
St Louis, Missouri, 63118
St Louis Clinical Trials
St Louis, Missouri, 63141
Collaborative Neuroscience Network Inc.
Torrance, California, 90502
About this study
Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Basmisanil (RO5186582) as Adjunctive Treatment in Patients With Cognitive Impairment Associated With Schizophrenia Treated With Antipsychotics
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
- Being tested
- Basmisanil, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasmisanilDrug
Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.
PlaceboDrug
Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. Receives: Drug: Placebo |
| Basmisanil 80mg BID | Experimental | Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. Receives: Drug: Basmisanil |
| Basmisanil 240mg BID | Experimental | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. Receives: Drug: Basmisanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 24
Secondary outcomes (14)
Change From Baseline to Week 24 in MCCB Cognitive Domain Scores
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). 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 T-score represents lower impairment.
Measured: Baseline up to Week 24
Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score
The Paired Associates Learning (PAL I and II) of the WMS-IV (Wechsler Memory Scale Fourth edition) is a test of verbal learning and memory that requires the participant to learn novel word pairs. The participant learns the word pairs across learning trials and is asked to recall them immediately (PAL I) or after a 30-minute delay (PAL II). Data is presented here for 3 Scores: VPA I total raw score, VPA II total raw score and VPA II Recognition total raw score. The total raw score ranges for these 3 Scores are 0 to 56, 0 to 14 and 0 to 40 respectively, with larger total raw scores indicating better performance.
Measured: Baseline up to Week 24
Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score
Logical memory (LM) assesses narrative memory under free-recall conditions. Two short stories are presented orally. The examinee is asked to retell each story from memory immediately after hearing it (LM I). In the delayed condition (LM II), the examinee is asked to retell both stories from the immediate condition (delayed free recall). Data is presented here for 2 Scores: LM I total raw score and LM II total raw score. The total raw score range is from 0 to 50 with larger total raw scores indicating better performance.
Measured: 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
The TMT consists of two parts: Trail Making Part A, which is a part of the standard MCCB and Trail Making Part B additionally included in this study. Circles containing numbers (Part A) or both numbers and letters (Part B) must be sequentially connected. The difference (ratio) in performance between Part A and Part B reflects executive processes and will be used to assess executive functioning including cognitive set shifting abilities and data for this ratio is presented here. Smaller ratio values, hence decreases from baseline (TMT-B/TMT-A ratio values below 1) indicate higher executive functioning capabilities.
Measured: Baseline up to Week 24
Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score
The PSP Total Score is an integer result in the range of 0 to 100. Larger values, hence increases from baseline in the PSP total score, indicate higher social and personal functioning.
Measured: Baseline up to Week 24
Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score
The main parameter of interest for the Schizophrenia Cognition Rating Scale (SCoRS) is the SCoRS 'Total Score'. The total score range is from 0 to 80 with lower scores indicating better day-to-day functioning.
Measured: Baseline up to Week 24
Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating
Values for the CGI-S Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment.
Measured: Baseline up to Week 24
Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating
Values for the CGI-I Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment.
Measured: Baseline up to Week 24
Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)
The SQLS is a patient reported scale consisting of 33 items: 2 domain scores (Cognition \& Vitality Score [SQLS-CV] and Psycho-social Score [SQLS-P]) as well as a Total score (SQLS-T) are derived. The overall score range is from 0 to 100. On all scales, higher scores represent a lower quality of life.
Measured: Baseline up to Week 24
Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Measured: Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks)
Apparent Clearance of Basmisanil at Steady State (CL/F,ss)
Population PK model estimated apparent oral clearance of Basmisanil at steady-state.
Measured: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)
Population PK model estimated apparent volume of distribution of Basmisanil at steady-state.
Measured: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Area Under the Curve of Basmisanil at Steady State (AUC,ss)
Population PK model estimated AUC of Basmisanil at steady-state.
Measured: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)
Population PK model estimated maximum plasma concentration of Basmisanil at steady-state (ss).
Measured: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start30 Nov 2016
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953639
- Sponsor's protocol ID
- BP39207
- Status last verified
- Jan 2021
- First submitted
- 1 Nov 2016
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Publications
Umbricht D, Abt M, Derks M, Hernandez MC, Parkar N, Negron D, Koerner A, Holiga S, Goeldner C. A Phase 2b Multicenter Study to Evaluate Basmisanil as an Adjunctive Treatment in Patients With Cognitive Impairment Associated With Schizophrenia. J Clin Psychiatry. 2026 Apr 15;87(2):25m16022. doi: 10.4088/JCP.25m16022.
PubMed 41983730
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Basmisanil (RO5186582) as Adjunctive Treatment in Patients With Cognitive Impairment Associated With Schizophrenia Treated With Antipsychotics
- ClinicalTrials.gov ID
- NCT02953639
- Acronym / sponsor ID
- BP39207
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Posted 9 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching Placebo to Basmisanil orally twice daily for 24 weeks. |
| Basmisanil 80mg BID | Experimental | Drug: BasmisanilParticipants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. |
| Basmisanil 240mg BID | Experimental | Drug: BasmisanilParticipants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BasmisanilParticipants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above. | Drug | Basmisanil 240mg BID, Basmisanil 80mg BID |
| PlaceboParticipants received matching Placebo to Basmisanil, as per the dosing schedules described above. | Drug | Placebo |
Primary outcome
Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
Time frame: Baseline up to Week 24
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.
14 secondary outcomes
Change From Baseline to Week 24 in MCCB Cognitive Domain Scores
Time frame: Baseline up to Week 24
Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score
Time frame: Baseline up to Week 24
Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score
Time frame: 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
Time frame: Baseline up to Week 24
Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score
Time frame: Baseline up to Week 24
Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score
Time frame: Baseline up to Week 24
Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating
Time frame: Baseline up to Week 24
Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating
Time frame: Baseline up to Week 24
Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)
Time frame: Baseline up to Week 24
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks)
Apparent Clearance of Basmisanil at Steady State (CL/F,ss)
Time frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)
Time frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Area Under the Curve of Basmisanil at Steady State (AUC,ss)
Time frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)
Time frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41983730Umbricht D, Abt M, Derks M, Hernandez MC, Parkar N, Negron D, Koerner A, Holiga S, Goeldner C. A Phase 2b Multicenter Study to Evaluate Basmisanil as an Adjunctive Treatment in Patients With Cognitive Impairment Associated With Schizophrenia. J Clin Psychiatry. 2026 Apr 15;87(2):25m16022. doi: 10.4088/JCP.25m16022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Basmisanil in people with Schizophrenia, run by Hoffmann-La Roche at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score (time frame: Baseline up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.