Phase 2
Completed N=98
Safety and Tolerability Study of Drug to Treat Schizophrenia
Source: ClinicalTrials.gov NCT00044005 ↗Enrolled (actual)
98
Serious AEs
12.2%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Adverse Events — 19; 22; 18 participants
Summary
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
19; 22; 18 | — |
Eligibility Criteria
Inclusion criteria
- Successful completion of participation in protocol #D1050049
Exclusion criteria
- Substance abuse
- Prolactin level of ≥200ng/mL at baseline
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00044005). 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.