Clinical trial NCT01649557: Multicenter, Open-label, Safety and Tolerability Study
Official title: A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-25
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Outpatient status at last visit of Study 331-07-203.

Exclusion Criteria:

1. 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.
2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
3. 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.
4. 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.
5. 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.
6. Subjects who would be likely to require prohibited concomitant therapy during the study.
7. Any subject who, in the opinion of the investigator, should not participate in the study.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) During First 6 Weeks.
timeFrame: From Baseline up to 6 weeks
measure: Number of Participants With AEs in 52-Week Enrollers.
timeFrame: From Baseline up to 52 weeks
Secondary outcomes:
measure: Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.
timeFrame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
measure: Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.
timeFrame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
measure: Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.
timeFrame: Baseline, Week 1, 2, 6, 26, 52 and Last Visit
measure: Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.
timeFrame: Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
measure: Change From Baseline in PANSS Positive Subscale Score.
timeFrame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
measure: Change From Baseline in PANSS Negative Subscale Score.
timeFrame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
measure: Percentage of Participants With a Positive Response Rate.
timeFrame: Last Visit
measure: Percentage of Participants Who Discontinued Due to Lack of Efficacy.
timeFrame: Last Visit
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Otsuka Investigational Site
state: Arkansas
city: Escondido
country: United States
facility: Otsuka Investigational Site
state: California
city: Garden Grove
country: United States
facility: Otsuka Investigational Site
state: California
city: Long Beach
country: United States
facility: Otsuka Investigational Site
state: California
city: Oceanside
country: United States
facility: Otsuka Investigational Site
state: California
city: Pasadena
country: United States
facility: Otsuka Investigational Site
state: California
city: San Diego
country: United States
facility: Otsuka Investigational Site
state: California
city: San Diego
country: United States
facility: Otsuka Investigational Site
state: California
city: Santa Ana
country: United States
facility: Otsuka Investigational Site
state: California
city: Washington
country: United States
facility: Otsuka Investigational Site
state: District of Columbia
city: Bradenton
country: United States
facility: Otsuka Investigational Site
state: Florida
city: Maitland
country: United States
facility: Otsuka Investigational Site
state: Florida
city: St. Louis
country: United States
facility: Otsuka Investigational Site
state: Missouri
city: Cedarhurst
country: United States
facility: Otsuka Investigational Site
state: New York
city: Philadelphia
country: United States
facility: Otsuka Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Otsuka Investigational Site
state: Texas
city: Burgas
country: Bulgaria
facility: Otsuka Investigational Site
city: Kazanlak
country: Bulgaria
facility: Otsuka Investigational Site
city: Pazardzhik
country: Bulgaria
facility: Otsuka Investigational Site
city: Plovdiv
country: Bulgaria
facility: Otsuka Investigational Site
city: Radnevo
country: Bulgaria
facility: Otsuka Investigational Site
city: Ruse
country: Bulgaria
facility: Otsuka Investigational Site
city: Rijeka
country: Croatia
facility: Otsuka Investigational Site
city: Zagreb
country: Croatia
facility: Otsuka Investigational Site
city: Vijaywada
country: India
facility: Otsuka Investigational Site
state: Andh Prad
city: Visakhapatnam
country: India
facility: Otsuka Investigational Site
state: Andh Prad
city: Ahmedabad
country: India
facility: Otsuka Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Otsuka Investigational Site
state: Karna
city: Mangalore
country: India
facility: Otsuka Investigational Site
state: Karna
city: Mangalore
country: India
facility: Otsuka Investigational Site
state: Karna
city: Pune
country: India
facility: Otsuka Investigational Site
state: Mahara
city: Chennai
country: India
facility: Otsuka Investigational Site
state: Tamilnadu
city: Varanasi
country: India
facility: Otsuka Investigational Site
state: Uttar Prad
city: Chuncheon
country: Korea, Republic of
facility: Otsuka Investigational Site
city: Incheon
country: Korea, Republic of
facility: Otsuka Investigational Site
city: Incheon
country: Korea, Republic of
facility: Otsuka Investigational Site
city: Seoul
country: Korea, Republic of
facility: Otsuka Investigational Site
city: Cebu City
country: Philippines
facility: Otsuka Investigational Site
city: Mandaluyong City
country: Philippines
facility: Otsuka Investigational Site
city: Arad
country: Romania
facility: Otsuka Investigational Site
city: Bucuresti 2
country: Romania
facility: Otsuka Investigational Site
city: Bucuresti 3
country: Romania
facility: Otsuka Investigational Site
city: Bucuresti
country: Romania
facility: Otsuka Investigational Site
city: Bucuresti
country: Romania
facility: Otsuka Investigational Site
city: Cluj - Napoca
country: Romania
facility: Otsuka Investigational Site
city: Oradea
country: Romania
facility: Otsuka Investigational Site
city: Moscow Region
country: Russian Federation
facility: Otsuka Investigational Site
city: Moscow
country: Russian Federation
facility: Otsuka Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Otsuka Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Otsuka Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Otsuka Investigational Site
city: Zagorodnoye
country: Russian Federation
facility: Otsuka Investigational Site
city: Belgrade 2
country: Serbia
facility: Otsuka Investigational Site
city: Belgrade
country: Serbia
facility: Otsuka Investigational Site
city: Kragujevac
country: Serbia
facility: Otsuka Investigational Site
city: NoviSad
country: Serbia
facility: Otsuka Investigational Site
city: Bojnice
country: Slovakia
facility: Otsuka Investigational Site
city: Bratislava
country: Slovakia
facility: Otsuka Investigational Site
city: Liptovsky Mikulas
country: Slovakia
facility: Otsuka Investigational Site
city: Rimavska Sobota
country: Slovakia
facility: Otsuka Investigational Site
city: Zilina
country: Slovakia
facility: Otsuka Investigational Site
city: Hualian
country: Taiwan
facility: Otsuka Investigational Site
city: Taipei
country: Taiwan
facility: Otsuka Investigational Site
city: Chernigiv
country: Ukraine
facility: Otsuka Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Otsuka Investigational Site
city: Kyiv
country: Ukraine
facility: Otsuka Investigational Site
city: Kyiv
country: Ukraine
facility: Otsuka Investigational Site
city: Kyiv
country: Ukraine
facility: Otsuka Investigational Site
city: Simferopol
country: Ukraine
facility: Otsuka Investigational Site
city: Stepanivka
country: Ukraine
facility: Otsuka Investigational Site
city: Vinnytsya
country: Ukraine
facility: Otsuka Investigational Site
Study officials:
References:
citation: Kane JM, Skuban A, Hobart M, Ouyang J, Weiller E, Weiss C, Correll CU. Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia. Schizophr Res. 2016 Jul;174(1-3):93-98. doi: 10.1016/j.schres.2016.04.013. Epub 2016 May 14.