Phase 3
Completed N=284
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01614912 ↗Enrolled (actual)
284
Serious AEs
11.0%
Results posted
Oct 2018
Primary outcomePrimary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint — -28.4 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The study evaluates the long term safety and efficacy of SM-13496 in patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint |
-28.4 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at LOCF Endpoint |
-1.46 | — |
| SECONDARY Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint |
-8.4 | — |
| SECONDARY Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint |
-6.9 | — |
| SECONDARY Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint |
-13.1 | — |
| SECONDARY Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) |
215 | — |
| SECONDARY Proportion of Participants With TEAEs Leading to Discontinuation |
39 | — |
| SECONDARY Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) |
31 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who are considered by the investigator eligible for the present study with no significant safety concerns
- Patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study
Exclusion Criteria
- Patients who are planning pregnancy for the expected duration of the study
- Patients who are otherwise considered ineligible for the study by the investigator
Data sourced from ClinicalTrials.gov (NCT01614912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.