Phase II clinical study of product CPL500036 in patients with an acute exacerbation of schizophrenia
- Conditions
- Acute exacerbation of schizophreniaTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2020-002316-51-PL
- Lead Sponsor
- Celon Pharma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 165
1. The patient has a primary diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [DSM 5], 295.90) confirmed by clinical interview (Structured Clinical Interview for DSM 5 Clinical Trial Version [SCID 5 CT]). The participant's initial diagnosis must be greater than or equal to (=) 2 years before Screening.
2. Male or female patient aged 18 to 65, inclusive, at Screening.
3. The patient's psychotic symptoms were exacerbated within 2 months (60 days) prior to Screening (e.g., aggravated delusion).
4. The patient has a score of 5 (moderate severe) or higher in 3 or more items of the following PANSS items at Screening and Day -1: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), and unusual thought content (G9).
5. The patient has a PANSS Total Score of 80 or higher during Screening and on Day -1.
6. A female is eligible to participate if she is not pregnant (negative pregnancy test at Screening and Day -1), not breastfeeding, and at least 1 of the following conditions applies:
a) Not a woman of childbearing potential (a woman is considered to be of non childbearing potential if she is post-menopausal for at least 12 months or is surgically sterile [hysterectomy, bilateral oophorectomy, tubal ligation]).
b) Woman of childbearing potential, who agree to use contraceptive methods during the Treatment Period and for at least 28 days after the last dose of the study drug.
The following are acceptable contraceptive methods: bilateral tubal occlusion, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices, male or female condom with spermicide; and cap, diaphragm, or sponge with spermicide.
7. Male patients must agree to use a barrier method of contraceptive (condom + spermicide gel) for at least 90 days after the last dose of the study drug.
8. The patient has a Clinical Global Impression Scale Severity of Illness Scale (CGI S) of 4 or greater at Screening and Day -1.
9. The patient is able to and agrees to remain off prior antipsychotic medication and all excluded medications as outlined in the protocol for the duration of the Treatment Period.
10. The patient is able to sign informed consent after receiving information about the trial.
11. The patient has the ability and willingness to comply with the requirements and restrictions of the study protocol.
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 165
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. The patient has a decrease in the PANSS Total Score by 20 percent (%) or more at Baseline (Day -1) compared with the Total Score at Screening ([PANSS Total Score at Screening PANSS Total Score at Baseline]/[PANSS Total Score at Screening 30)]*100 = 20%).
2. Patient participated in another interventional clinical study with an IMP during the last 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
3. The patient has uncontrolled, hypertension, hypotension, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the patient to participate or potentially confound the study results.
4. The patient has a history of severe head injury, traumatic brain injury, myocardial infarction or stroke.
5. The patient has a positive urine drug result (illicit, illegal or without valid prescription or medical need) at Screening.
6. The patient has a moderate or severe substance use disorder (meeting more than 4 diagnostic criteria of DSM 5 either currently or within the last 6 months) for alcohol or other substances of abuse except nicotine or caffeine.
7. If female, the patient is pregnant (a positive pregnancy test at Screening or Day -1) or lactating or intending to become pregnant or intending to donate ova, before or during the course of the study or within 12 weeks after the last dose.
8. The patient has a history of or known personality disorder or other psychiatric disorder that, in the opinion of the Investigator, would interfere with participation in the study.
9. The patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus or other conditions that may interfere with absorption of study drug.
10. The patient is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property or participants who within the past year prior to Screening have attempted suicide or have positive answers on item 4 or 5 on the C SSRS at Screening or on Day -1.
11. The patient has Parkinson’s disease, tardive dyskinesia, or other chronic movement disorder that may interfere with the interpretation of study results.
12. The patient has any existing or previous history of cancer that has been in remission for less than 5 years prior to Screening.
Note: this criterion does not include those participants with basal cell, stage I squamous cell skin cancer or in situ cervical cancer.
13. The patient has newly diagnosed diabetes or requires insulin for their treatment; diabetic patients that have had changes to their diabetic treatment regimen within 30 days prior to Screening or diabetic patients that have been hospitalized for their diabetes and/or diabetes related conditions in the past year prior to Screening.
14. The patient has long QT syndrome or is under treatment with Class 1A (e.g., quinidine, procainamide) or Class 3 (e.g., amiodarone, sotalol) anti arrhythmic drugs.
15. The patients with acute or chronic hepatitis B or C infection (positive test for hepatitis B surface antigen; positive hepatitis C antibody), known human immunodeficiency virus (HIV) infection, or other acute or ongoing clinically significant viral or bacterial infections..
16. The patient has received any depot preparation (sustained release formulation) of antipsychotic drugs within 1 month (30 days) prior to Screeni
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method