Trial · NCT02431702
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part-2 (Disease Progression): Time to First Treatment Failure | From Day 1 up to 9 Months | Part 2 Intent-to-Treat (ITT) analysis set included all randomized participants who received at least one dose of study medication (or any portion of the dose) in Part 2, regardless of their compliance with the protocol. | days | MEDIAN |
| PRIMARY | Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and 18 Months | Part 3 ITT analysis set included all randomized participants who received at least one dose of study medication (or any portion of the dose) in Part 3, regardless of their compliance with the protocol. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | T-score | MEAN |
| PRIMARY | Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and Day 260 | Part 3 ITT analysis set included all randomized participants who received at least one dose of study medication (or any portion of the dose) in Part 3, regardless of their compliance with the protocol. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and Month 9 | Analysis was performed on Part 2 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score | Baseline and Month 9 | Analysis was performed on Part 2 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Adjusted Intracortical Myelin (ICM) Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI) | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | ratio | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Visual Learning Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Reasoning and Problem Solving: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Social Cognition Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score | Baseline, up to 9 Months of Part 2 | Analysis was performed on Part 2 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Part 2 (Disease Progression): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS) | Baseline, up to 9 Months | Analysis was performed on Part 2 ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Total Score | Baseline and endpoint Part 2 (up to 9 Months) | Analysis was performed on Part 2 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Part 3 (EDP): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score | Baseline and 18 Months | Analysis was performed on part 3 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Part 3 (EDP): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI) | Baseline and 18 Months | Analysis was performed on Part 3 ITT analysis set. | ratio | MEAN |
| SECONDARY | Part 3 (EDP): Time to First Treatment Failure | From Day 1 Up to 18 Months | Analysis was performed on Part 3 ITT analysis set. | days | MEDIAN |
| SECONDARY | Part 3 (EDP): Change From Baseline in Working Memory Score: MCCB Domain | Baseline and 18 Months | Analysis was performed on Part 3 ITT analysis set. | T-score | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02431702/outcomes