Phase 2
Completed N=244
Multicenter, Open-label, Safety and Tolerability Study
Source: ClinicalTrials.gov NCT01649557 ↗Enrolled (actual)
244
Serious AEs
4.6%
Results posted
Oct 2015
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) During First 6 Weeks. — 79; 19; 7; 78 Participants
Summary
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) During First 6 Weeks. |
79; 19; 7; 78; 19; 7 | — |
| PRIMARY Number of Participants With AEs in 52-Week Enrollers. |
15; 4; 2; 15; 4; 2 | — |
| SECONDARY Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. |
0.11; -1.25; -1.50; -2.03; -1.53; -1.91 | — |
| SECONDARY Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. |
0.02; -0.03; 0.05; -0.08; -0.05; -0.04 | — |
| SECONDARY Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. |
-2.00; -21.00; -5.00; 1.00; 1.50; 0.00 | — |
| SECONDARY Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. |
3.70; 3.56; 3.23; 3.51; 3.73; 3.13 | — |
| SECONDARY Change From Baseline in PANSS Positive Subscale Score. |
-0.04; -0.50; 0.09; -0.66; -0.25; -0.78 | — |
| SECONDARY Change From Baseline in PANSS Negative Subscale Score. |
-0.01; -0.25; -0.86; -0.47; -0.40; -0.87 | — |
| SECONDARY Percentage of Participants With a Positive Response Rate. |
33.5; 36.6; 45.8 | — |
| SECONDARY Percentage of Participants Who Discontinued Due to Lack of Efficacy. |
2.8; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who participated in 331-07-203 and who, in the opinion of the investigator, have the potential to benefit from continued administration of OPC-34712 for the treatment of schizophrenia.
- Outpatient status at last visit of Study 331-07-203.
Exclusion Criteria
- Sexually active males who are not practicing two different methods of birth control during the study and for 90 days after the last dose of study medication or who will not remain abstinent during the study and for 90 days after the last dose, or sexually active females of childbearing potential who are not practicing two different methods of birth control during the study and for 30 days after the last dose of study medication or who will not remain abstinent during the study and for 30 days after the last dose. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injection, birth control implant, condom, or sponge with spermicide.
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
- Subjects who during the course of their participation in 331-07-203 were treated in violation of the protocol or who developed ANY exclusion criteria during the course of their participation.
- Subjects who do not continue to meet all applicable inclusion/exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.
- Subjects who represent a risk of committing suicide based on an answer of "Yes" to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS, or an answer of "Yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) on the "Suicidal Behavior" portion of the C-SSRS. A subject who has had any suicidal ideation within the last 6 months, any suicidal behaviors within the last two years, or who in the clinical judgment of the investigator presents a serious risk of suicide should be excluded from the study.
- Subjects who would be likely to require prohibited concomitant therapy during the study.
- Any subject who, in the opinion of the investigator, should not participate in the study.
Data sourced from ClinicalTrials.gov (NCT01649557). 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.