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

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• Schizophrenia 3,471
• Cognitive Dysfunction 3,843

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 214 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Placebo comparator
  Placebo

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

  Drug: Placebo

• Experimental
  Basmisanil 80mg BID

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

  Drug: Basmisanil

• Experimental
  Basmisanil 240mg BID

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

  Drug: Basmisanil

Interventions

• DrugBasmisanil

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

• DrugPlacebo

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

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.

   Time frame: Baseline up to Week 24

Secondary outcomes

1. 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.

   Time frame: Baseline up to Week 24

2. 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.

   Time frame: Baseline up to Week 24

3. 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.

   Time frame: Baseline up to Week 24

4. 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.

   Time frame: Baseline up to Week 24

5. 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.

   Time frame: Baseline up to Week 24

6. 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.

   Time frame: Baseline up to Week 24

7. 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.

   Time frame: Baseline up to Week 24

8. 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.

   Time frame: Baseline up to Week 24

9. 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.

   Time frame: Baseline up to Week 24

10. 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.

    Time frame: Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks)

11. Apparent Clearance of Basmisanil at Steady State (CL/F,ss)

    Population PK model estimated apparent oral clearance of Basmisanil at steady-state.

    Time frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168

12. 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.

    Time frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168

13. Area Under the Curve of Basmisanil at Steady State (AUC,ss)

    Population PK model estimated AUC of Basmisanil at steady-state.

    Time frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168

14. Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)

    Population PK model estimated maximum plasma concentration of Basmisanil at steady-state (ss).

    Time frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168

Baseline characteristics

Study documents

• Study protocol · Jul 31, 2018
• Statistical analysis plan · Nov 29, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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).