Study to evaluate the efficacy of ALKS 3831 on body weight in young adults who have been recently diagnosed with Schizophrenia, Schizophreniform or Bipolar I Disorder

• Register: EUCTR
• Last refreshed on: 2 March 2022
• Main ID: EUCTR2017-000497-11-AT
• Date of registration: 12/06/2017
• Prospective Registration: Yes
• Primary sponsor: Alkermes Inc
• Public title: Study to evaluate the efficacy of ALKS 3831 on body weight in young adults who have been recently diagnosed with Schizophrenia, Schizophreniform or Bipolar I Disorder
• Scientific title: A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder Who are Early in Their Illness
• Date of first enrolment: 13/07/2017
• Target sample size: 425
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000497-11
• 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: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Germany, Ireland, Israel, Italy, Poland, Spain, United Kingdom, United States

Contacts

• Name: Clinical Development
• Affiliation: Alkermes Inc

• Name: Clinical Development
• Affiliation: Alkermes Inc

Key inclusion & exclusion criteria

Inclusion criteria:
For US sites, men and women =16 through <40 years of age at Screening.
For European non-US sites, men and women =18 through <40 years of age at Screening. Subjects will have a body-mass index (BMI) of <30.0 kg/m2 at Screening and Visit 2, with a Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder and meet Sponsor criteria for previous antipsychotic treatment and duration of illness. Subjects with bipolar I disorder must have been experiencing an acute episode of mania as defined by DSM-5 within the last 14 days prior to Visit 1.

Please refer to the protocol for full list of Inclusion Criteria
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 425
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects may be excluded based on diagnosis of additional psychiatric conditions, use of prohibited or contraindicated drugs and medications, pre-existing medical conditions, abnormal lab results during Screening, participation in any recent clinical trials or previous clinical trials of ALKS 3831 or samidorphan, pregnancy and relationship to an employee of the study Sponsor, CRO, Investigator, or study site.

Please refer to the protocol for full list of Exclusion Criteria


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

Health Condition(s) or Problem(s) studied

Schizophrenia, schizophreniform disorder or bipolar I disorder
MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 21.1 Level: PT Classification code 10039647 Term: Schizophreniform disorder System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 20.0 Level: PT Classification code 10004939 Term: Bipolar I disorder System Organ Class: 10037175 - Psychiatric disorders

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

Intervention(s)

Product Name: ALKS 3831 5 mg/10 mg
Product Code: ALKS 3831
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Current Sponsor code: OLZT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Samidorphan L-Malate
CAS Number: 1204592-75-5
Current Sponsor code: RDC-0313-02; ALKS 33
Other descriptive name: SAMIDORPHAN L-MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: ALKS 3831 10 mg/10 mg
Product Code: ALKS 3831
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Current Sponsor code: OLZT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Samidorphan L-Malate
CAS Number: 1204592-75-5
Current Sponsor code: RDC-0313-02; ALKS 33
Other descriptive name: SAMIDORPHAN L-MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: ALKS 3831 15 mg/10 mg
Product Code: ALKS 3831
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Current Sponsor code: OLZT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
INN or Proposed INN: Samidorphan L-Malate
CAS Number: 1204592-75-5
Current Sponsor code: RDC-0313-02; ALKS 33
Other descriptive name: SAMIDORPHAN L-MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: ALKS 3831 20 mg/10 mg
Product Code: ALKS 3831
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Current Sponsor code: OLZT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12

Main Objective: To evaluate the effect of ALKS 3831, compared to olanzapine, on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness

Secondary Objective: To evaluate the safety and tolerability of ALKS 3831 in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness

Primary end point(s): Percent change from baseline in body weight at week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: - Weight gain – week 12

Secondary end point(s): - Proportion of subjects with =10% weight gain at week 12
- Proportion of subjects with =7% weight gain at week 12
- Change from baseline in waist circumference at Week 12
- Change from baseline in CGI-S score within the ALKS 3831 Group at Week 12

Secondary ID(s)

ALK3831-A307

Source(s) of Monetary Support

Alkermes Inc

Ethics review

Status: Approved
Approval date: 04/07/2017
Contact: