Negative Symptoms of Schizophrenia MedDRA version: 20.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: MIN-101 GR01/B 32mg
Product Code: MIN-101 32mg
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: roluperidone hydrochloride
CAS Number: 1937215-88-7
Current Sponsor code:
Sponsors
Minerva Neurosciences, Inc.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential patient must satisfy all the following criteria to be enrolled in the study: 1. Patient and patient's legal representative, if applicable, provided informed consent prior to the initiation of any study related procedures, and the patient is judged by the investigator as being capable of understanding the study requirements. 2. Male or female patient, 18 to 55 years of age, inclusive, and body mass index (BMI) 20 on the PANSS negative subscore (the original PANSS scale [Sum of N1+N2+N3+N4+N5+N6+N7]) at Screening (Visit 1) and Baseline (Visit 3) AND < 4 points absolute difference between the 2 visits. 9. Patients can be on any psychotropic before the trial if the psychotropics can be discontinued at the beginning of the washout phase without risking the patient’s clinical status or safety. 10. No history of violence against self or others during the last 1 year. 11. Female patient who are not of childbearing potential, defined as women who are post- menopausal (defined as spontaneous amenorrhoea for at least 1 year or spontaneous amenorrhoea for at least 6 months confirmed by follicle stimulating hormone result of = 40 IU/mL) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy). 12. Female patient, if of childbearing potential, must test negative for pregnancy and must be using a double barrier contraceptive method. 13. Patient must be extensive (normal) metabolizers for P450 CYP 2D6, defined as a subject that has at least one functional allele (e.g., *1, or *2), as determined by study-specific genotyping test before the first drug dose is administered. 14. Patient and the caregiver are considered by the investigator to be reliable and likely to cooperate with the assessment procedures. Are the trial subjects under 18
Exclusion criteria
Exclusion criteria: Any potential patient who meets any of the following criteria will be excluded from participating in the study: 1. Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual developmental disorder diagnosed by age 14). 2. Patient with PANSS item score of > 4 on: • P4 Excitement/Hyperactivity • P6 Suspiciousness/persecution • P7 Hostility • G8 Uncooperativeness • G14 Poor impulse control 3. A CDSS total score > 6. 4. A score of = 2 on any 2 of items 1, 2, or 3, or a score of = 3 on item 4 of the Barnes Akathisia Rating Scale (BARS). 5. Patient’s condition is due to direct physiological effects of a substance (e.g., a drug of abuse, or medication) or a general medical condition. 6. Has a current or recent history of serious suicidal behavior within the past 1 year. 7. Patient has a history of substance use disorder within 3 months of the Screening visit (excluding caffeine and cigarette smoking). 8. Positive urine drug screen for drugs of abuse (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, and barbiturates), tricyclic antidepressants (TCA), and alcohol (except for prescription benzodiazepines). 9. Patient who cannot be discontinued from psychotropics other than those allowed. 10. Patient who received clozapine within 6 months of the Screening visit except when used for insomnia at doses = 100 mg per day. 11. Patient receiving treatment with long-acting or depot antipsychotic medication unless his/her next scheduled dose will occur during the protocol Screening period and can be omitted to allow for sufficient washout before receiving the study drug. 12. Patient with a history of significant other major or unstable neurological, neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, metabolic, gastrointestinal, or urological disorder. 13. Patient with a history of seizures (patient with a history of a single childhood febrile seizure may be enrolled in this study). 14. Patient who has had electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), or repetitive trans-cranial magnetic stimulation (r-TMS) within the 6 months prior to the Screening visit or who are scheduled for ECT, VNS, or r-TMS at any time during the study. 15. Patient with clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit which according to Investigator can interfere with study participation. 16. Current systemic infection (e.g., Hepatitis B, Hepatitis C, human immunodeficiency virus [HIV], tuberculosis). Patients with positive Hepatitis B core antibody test and negative Hepatitis B Surface Antigen (HBsAg) may be included in the study if aminotransferase levels (alanine aminotransferase/ serum glutamic pyruvic transaminase [ALT/SGPT] and aspartate aminotransferase/ serum glutamic oxaloacetic transaminase [AST/SGOT]) do not exceed 2 times upper limit of normal (ULN). 17. Patient who requires or may require concomitant treatment with any other medication likely to increase QT interval (e.g., paroxetine, fluoxetine, duloxetine, amiodarone). 18. Patient who requires medication inhibiting CYP 2D6 or CYP 3A4. 19. Patient with a clinically significant ECG abnormality that could be a safety issue in the study, including QT interval value corrected for heart rate using the Fridericia’s formula (QTcF) > 430 msec for males and > 450 msec
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): End point for Key Secondary: - Change from Baseline in the PSP Total score End point for Secondary - Change from Baseline in the CGI-S score - Safety assessments, including adverse events, laboratory values, ECG, vital signs, physical exam, Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), Simpson-Angus Scale (SAS) and the Sheehan Suicidality Tracking Scale (Sheehan-STS).;Timepoint(s) of evaluation of this end point: • PSP at Baseline and WKS 4, 8, 12, and at WKS 16, 24, 32, 40, 48, and 52 (or early withdrawal). • CGI-S at Baseline and WKS 2, 4, 8, 12, and at WKS 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and 54 (EOS or early withdrawal). • Adverse events, laboratory values, ECG, vitals signs, physical exam, AIMS, BARS, Simpson-Angus Scale (SAS) and Sheehan-STS: throughout the study | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 2 fixed doses (32 mg and 64 mg) of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change in the Positive and Negative Syndrome Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks of double-blind treatment.;Secondary Objective: Key Secondary To assess the effect of MIN-101 compared to placebo on the Personal and Social Performance (PSP) total score, over 12 weeks of double-blind treatment. Secondary To assess the effect of MIN-101 compared to placebo over 12 weeks of double-blind treatment on: • Clinical Global Impression of Severity (CGI-S). • Safety and tolerability. ;Primary end point(s): Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Marder negative symptoms factor score (NSFS);Timepoint(s) of evaluation of this end point: Efficacy will be evaluated based on the change from Baseline in PANSS NSFS after 12 weeks of treatment or at early withdrawal. | — |
Countries
Bulgaria, Georgia, Israel, Moldova, Republic of, Poland, Romania, Ukraine, United States
Contacts
Public ContactDirector of Clinical Operations
PPRS
Outcome results
None listed