Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

Therapuetic Areas:Psychiatry / Psychology
Age Range:18 - 55
Start Date:December 15, 2017
End Date:March 2020
Contact:Michael Davidson, MD

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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension

MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled,
parallel-group study to evaluate the efficacy and safety of roluperidone in adult
schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of
roluperidone compared to placebo in improving the negative symptoms of schizophrenia over 12
weeks of double-blind treatment as measured by the change in Positive and Negative Syndrome
Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.

Inclusion Criteria:

- 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.

- Male or female patient, 18 to 55 years of age, inclusive, and body mass index (BMI) <
35 kg/m(2) at Screening.

- Patient meets the diagnostic criteria for schizophrenia as defined in the Diagnostic
and Statistical Manual of Mental Disorders (DSM-5), as established by a full
psychiatric interview in conjunction with the Mini International Neuropsychiatric

- Has a reliable caregiver or family member or health care personnel who can provide
information towards assessment and support the patient in terms of compliance with the
protocol. The caregiver must have contacts with the patient daily for at least 1 hour
each time and is not expected to change during the trial.

- Documented diagnosis of schizophrenia for at least 1 year before screening into the

- Patient is stable in terms of positive and negative symptoms of schizophrenia over the
last 6 months according to his or her treating psychiatrist and based on documentation
in the clinical chart.

- Patient is currently an outpatient and has not been hospitalized for the last 6 months
for acute exacerbation or symptoms worsening. Patients hospitalized during the last 6
months for social reasons or are currently hospitalized for social reasons can be
included only with Sponsor's Responsible Medical Officer's approval, and the social
reasons must be documented in the electronic case report form (eCRF).

- Patient with a score of > 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 2 visits.

- 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.

- No history of violence against self or others during the last 1 year.

- Female patient who are not of childbearing potential, defined as women who are
postmenopausal (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

- Female patient, if of childbearing potential, must test negative for pregnancy and
must be using a double barrier contraceptive method.

- Patient must be extensive metabolizers for cytochrome P450 (CYP2D6), defined as a
subject that has at least one functional allel (e.g., *1 or *2), as determined by
study-specific genotyping test before the first drug dose is administered.

- Patient and the caregiver are considered by the investigator to be reliable and likely
to cooperate with the assessment procedures.

Exclusion Criteria:

- Current major depressive disorder, bipolar disorder, panic disorder, obsessive
compulsive disorder, or intellectual disability (intellectual developmental disorder
diagnosed by age 14).

- Patient with PANSS item score of > 4 on: P4 excitement/hyperactivity, P6
suspiciousness/persecution, P7 hostility, G8 uncooperativeness, G14 poor impulse

- A Calgary Depression Scale for Schizophrenia (CDSS) total score > 6.

- A score of ≥ 2 on any 2 items 1, 2, or 3, or a score of ≥ 3 on item 4 of the Barnes
Akathisia Rating Scale (BARS).

- Patient's condition is due to direct psychological effects of a substance (e.g., a
drug of abuse, or medication) or a general medical condition.

- Has a current or recent history of serious suicidal behavior within the past 1 year.

- Patient has a history of substance use disorder within 3 months of the Screening visit
(excluding caffeine and cigarette smoking).

- 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).

- Patient who cannot be discontinued from psychotropics other than those allowed.

- Patient who received clozapine within 6 months of the Screening visit.

- 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.

- Patient with a history of significant other major or unstable neurological,
neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological,
pulmonary, cardiovascular, gastrointestinal, or urological disorder.

- Patient with a history of seizures (patient with a history of a single childhood
febrile seizure may be enrolled in this study).

- 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

- 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.

- 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 (ALT)/ serum glutamic pyruvic
transaminase (SGPT) [ALT/SGPT] and aspartate aminotransferase (AST)/ serum glutamic
oxaloacetic transaminase (SGOT) [AST/SGOT] do not exceed 2 times upper limit of normal

- Patient who requires or may require concomitant treatment with any other medication
likely to increase QT interval (e.g., paroxetine, fluoxetine, duloxetine, amiodarone).

- Patient who requires medication inhibiting CYP 2D6 or CYP 3A4.

- 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 for females.

- Patient with a history of myocardial infarction based on medical history or ECG
findings at Screening.

- Familial or personal history of long QT syndrome or with additional risk factors for
Torsade de Pointes.

- Subjects whose safety laboratory results show hypokalemia, hypomagnesemia,

- Patients with unexplained syncope.

- Woman of child-bearing potential, or man, who are unwilling or unable to use accepted
methods of birth control.

- Woman with a positive pregnancy test, is lactating, or is planning to become pregnant
during the study.

- Patient who participated in another clinical study within 3 months prior to Screening,
or received roluperidone previously, or has previously participated in > 2 clinical
studies with experimental medication (previous participation in 3 clinical studies
with experimental medication will require approval of the sponsor before eligibility
is determined).
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