A safe and effective cariprazine in preventing relapse for patients with schizophrenia

• Register: EUCTR
• Last refreshed on: 17 August 2015
• Main ID: EUCTR2011-002048-29-SK
• Date of registration: 03/11/2011
• Prospective Registration: Yes
• Primary sponsor: Forest Research Institute, Inc
• Public title: A safe and effective cariprazine in preventing relapse for patients with schizophrenia
• Scientific title: A randomized, double-blind, placebo-controlled, parallel-group study of cariprazine (RGH-188) in the prevention of relapse in patients with schizophrenia - Relapse prevention in patients with schizophrenia
• Date of first enrolment: 29/03/2012
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002048-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Argentina, Bulgaria, Colombia, India, Philippines, Romania, Slovakia, Ukraine

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Quintiles

• Name: Clinical Trial Information Desk
• Affiliation: Quintiles

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written (signed or thumb printed in accordance with local regulations to ensure protection of patient’s rights) informed consent obtained from the patient before the initiation of any study-specific procedures
2. Male or female inpatient, 18 to 60 years of age, inclusive
3. Current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (295.30 Paranoid Type, 295.10 Disorganized Type, 295.20 Catatonic Type, or 295.90 Undifferentiated Type) as determined by the Structured Clinical Interview for DSM-IV (SCID)
4. Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
5. Current psychotic episode < 4 weeks duration at Visit 1
6. PANSS total score = 70 and = 120 at Visit 1 and Visit 2
7. Rating of at least 4 (moderate) on at least two of the following four PANSS positive symptoms; delusions, hallucinatory behavior, conceptual disorganization, suspiciousness/persecution at Visit 1 and Visit 2
8. Patients who are capable of being compliant with self-administration of medication
9. Negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test (applies to female patients of childbearing potential only)
10. Normal physical examination findings, vital signs, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the PI and documented as such in the eCRF
11. Body mass index between 18 and 40 kg/m2, inclusive (rounded to nearest whole number)
12. Patients must be able to speak and understand the local language sufficiently to understand the nature of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Currently meeting DSM-IV-TR criteria for some diseases (see protocol)
2. Patients in their first episode of psychosis
3. Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the drug’s package insert)
4. Positive result from the blood alcohol test or from the urine drug screen (UDS) for any prohibited medication
5. History of intolerance or hypersensitivity to a typical or atypical antipsychotic or to designated rescue medications or any history of severe drug allergy or hypersensitivity
6. At imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
7. Suicide risk
8. Electroconvulsive therapy in the 3 months before Visit 1
9. Previous lack of response to electroconvulsive therapy
10. Treatment with a depot neuroleptic within 1 cycle before Visit 1
11. Treatment with clozapine in the past 10 years (exceptions: 1. Episodic use of clozapine at doses = 100 mg/day for the treatment of insomnia. 2. For non-US countries only, with prior approval from the Forest Medical Monitor or designee, past use of clozapine at doses = 350 mg/day as treatment for schizophrenia symptoms in patients who had not demonstrated treatment resistance or intolerance to other antipsychotics and who did not require it for the treatment of suicidality)
12. Requiring concomitant treatment with any of the prohibited medications, supplements, or herbal products, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component
13. At Visit 2, requiring pharmacologic treatment for the control of EPS
14. Prior participation in any investigational study of cariprazine (RGH-188)
15. Women who meet the following criteria:
- Pregnant, breastfeeding, and/or planning to become pregnant and/or breastfeed during the study
- Not at least 2 years postmenopausal, surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing a reliable method of contraception that will continue for the duration of the study.
16. Any concurrent medical condition that, in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being
17. Any cardiovascular disease that is clinically significant, unstable, or decompensated.
18. Hypo- or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 3 months before Visit 1
19. Psychiatric symptoms possibly secondary to any other general medical condition (eg, Vitamin B-12/folate deficiency, Cushing syndrome, etc)
20. Gastric bypass or any condition that would be expected to affect drug absorption (gastric banding procedures are acceptable if not associated with absorption problems)
21. History of seizure disorder, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes the patient toward a risk for seizure
22. Known history of cataracts, a finding of cataract at the screening ophthalmologic examination, or presence of any LOCS III findings at the screening ophthalmologic examination
23. Patients who meet some ophthalmologic criteria
24. Known human immunodeficiency virus infection
25. Positive test for hepatitis C infection
26. Po

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

schizophrenia
MedDRA version: 14.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Intervention(s)

Product Name: Cariprazine
Product Code: RGH-188
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Cariprazine HCl
CAS Number: 839712-12-8
Current Sponsor code: RGH-188 HCl
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 4.0-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Not applicable

Primary end point(s): Time to first relapse during the DBP
Relapse during the DBP will be defined as meeting any one or more of the following criteria:
1. Psychiatric hospitalization due to worsening of the patient’s underlying condition
2. Increase in PANSS total score by =30% for patients who scored 50 or higher at randomization or a 10-point or more increase for patients who scored less than 50 at randomization (Note: Patient should meet this criterion at a second assessment that is 4 to 7 days apart [exception: Based on severity for safety reasons the PI has discretion
not to perform a second assessment])
3. Increase in the Visit 14 CGI-S score by 2 or more points (Note: Patient should meet this criterion at a second assessment that is 4 to 7 days apart [exception: Based on severity for safety reasons the PI has discretion not to perform a second assessment])
4. Deliberate self-injury or aggressive/violent behavior
5. Suicidal or homicidal ideation that was clinically significant as judged by the PI
6. Score of greater than 4 on 1 or more of the following PANSS items: P1, P2, P3, P6, P7, G8 or G14 (Note: Patient should meet this criterion at a second assessment that is 4 to 7 days apart [exception: Based on severity for safety reasons the PI has discretion not to perform a second assessment])
Relapse

Timepoint(s) of evaluation of this end point: Time to Relapse

Main Objective: To evaluate the efficacy and safety of cariprazine (RGH-188) relative to
placebo in the prevention of relapse of symptoms in patients with
schizophrenia

Secondary Outcome(s)

Secondary end point(s): Not Applicable

Timepoint(s) of evaluation of this end point: NA

Secondary ID(s)

NCT01412060

RGH-MD-06

Source(s) of Monetary Support

Forest Research Institute, USA

Gedeon Richter Plc