A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, 6-Week, Hospitalized Patients, Study to Assess Efficacy and Safety of HP-3070 in Subjects with Schizophrenia
- Conditions
- SchizophreniaMedDRA version: 18.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2015-005134-21-SK
- Lead Sponsor
- oven Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 617
1.Adult male or female subjects, =18 years of age.
2. Subject is able to undergo informed consent process and signs ICF.
3. Subject has current diagnosis of schizophrenia as per DSM-5 Criteria, Mini
International Neuropsychiatric Interview (MINI), and as confirmed by Investigator
assessment.
4. Subject has PANSS total score =80, AND score of 4 or more in at least 2 of the
following PANSS items at Screening and at Baseline:
a. Conceptual disorganization
b. Delusions
c. Hallucinatory behavior
d. Unusual thought content
5. Subject has CGI-S scale score of =4 (moderately ill) at Screening and Baseline.
6.Subject has history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment, excluding the current episode.
7. Subject is confirmed by the Investigator to be experiencing an acute exacerbation of schizophrenia, as evidenced by ALL of the following:
a. The duration of the current episode is no more than 8 weeks.
b. The subject’s current symptoms represent a marked and substantial
exacerbation of schizophrenia compared with the subject’s symptomatic state
prior to the emergence of the current episode.
c. A corresponding functional deterioration to the symptomatic exacerbation is
evident.
8. Subject has not been hospitalized for more than 21 days for the current episode by the day of the Screening Visit, not including social hospitalization (e.g., homelessness or need for shelter that is unrelated to the subject’s underlying psychiatric condition).
9. Subject agrees not to begin formal, structured psychotherapy targeting the symptoms of schizophrenia from the time of the Screening Visit until the last dose of study drug.
10. Subject would benefit from hospitalization or continued hospitalization for the treatment of schizophrenia (as determined by the Investigator).
11. Subjects must not be treatment naïve or treatment resistant. Treatment resistance is defined as having 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).
12. Subject has had previous positive response to an antipsychotic medication other than clozapine in a prior episode.
13. Subject has a stable living situation and caretaker support when not hospitalized.
14. Subject is male, or a female who is not of childbearing potential (i.e., surgically sterile, postmenopausal for at least 1 year) or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.
15. Subjects must agree that they will not donate sperm or eggs from the time of the Screening Visit until 3 months following administration of the last treatment or dose of study medication.
16. Agrees not to use any other transdermal patch products (e.g., nicotine replacement patch, hormonal replacement patch, etc.) for the duration of the study.
17. Subject must be able to wear a transdermal patch for 24 hours.
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 551
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 61
1.Subject is presenting with a first episode of schizophrenia based on the clinical
judgment of the Investigator.
2. Subject has been diagnosed with schizophrenia less than 6 months prior to Screening Visit.
3. Subject has received electroconvulsive therapy (ECT), transcranial magnetic
stimulation (TMS), vagal nerve stimulation (VNS), or other brain stimulation
treatments within 90 days of Screening Visit.
4. Subject has a current DSM-5 diagnosis other than schizophrenia including (but not limited to) schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders.
5. Subject has a diagnosis of mental retardation, history of traumatic brain injury
causing ongoing cognitive difficulties, Alzheimer’s Disease or another form of
dementia (or suspicion thereof), or any chronic organic disease of the central nervous system that would interfere with the efficacy or safety endpoints of the study.
6. Subject has experienced acute depressive symptoms within 30 days prior to Screening Visit that requires treatment with an antidepressant, as determined by the Investigator.
7. Subject is a known non-responder to previous asenapine treatment, as per Investigator judgment.
8.Subject is currently taking clozapine for the treatment of schizophrenia. Subjects taking low doses of clozapine (up to 100 mg/day) for sedative properties and not treatment resistance or suicidality may be acceptable as per Investigator judgment and as approved by the Sponsor/designee.
9. Subject with schizophrenia who is considered resistant/refractory to antipsychotic treatment by history or who has a history of failure to respond to clozapine or response to clozapine treatment only. Treatment resistance is defined as having 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.
10. Subject who is unwilling to discontinue or, in the opinion of the Investigator, unable to discontinue any prohibited medication prior to the Baseline Visit without significant medical or psychiatric destabilization, or increased suicidality, as per the washout requirements.
11. Subjects taking drugs (current antipsychotic or other prohibited medication) that require >14 days for washout
12. Subject who is involuntarily committed, incarcerated, or under legal compulsion to seek psychiatric treatment.
13. Subject currently has clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure,human immunodeficiency virus (HIV) seropositive status/acquired immunodeficiency syndrome (AIDS).
14. Subject has any other medical condition or laboratory result that, in the opinion of the Investigator make the subject unsuitable.
Subjects with the following laboratory test and ECG results are excluded:
a. Platelets =75,000/mm3
b. Hemoglobin =9 g/dL
c. Neutrophils, absolute =1000/mm3
d. Aspartate transaminase (AST) >2×upper limit of normal (ULN)
i. QT interval corrected using Fridericia’s formula (QTcF) =450 msec (males),
QTcF =470 msec (females)
j. Prolactin
16. Subject with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least the past 90 days); subjects with abnormal f
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