Study to evaluate the long term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder.

• Register: EUCTR
• Last refreshed on: 20 November 2023
• Main ID: EUCTR2017-000918-36-AT
• Date of registration: 12/06/2017
• Prospective Registration: Yes
• Primary sponsor: Alkermes Inc
• Public title: Study to evaluate the long term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder.
• Scientific title: A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects with Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder
• Date of first enrolment: 13/07/2017
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000918-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• 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, Bulgaria, Ireland, Israel, Italy, Korea, Democratic People's Republic of, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Development
• Affiliation: Alkermes Inc

• Name: Clinical Development
• Affiliation: Alkermes Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject is willing and able to give informed consent/assent as per local requirements
2. Subject agrees to use an acceptable method of contraception during the study, and until 30 days after any study drug administration, unless surgically sterile or post-menopausal
3. Subject has the potential to benefit from the administration of ALKS 3831, in the opinion of the Investigator
4. Subject met eligibility criteria and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307

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 494
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion criteria:
1. Subject has any finding that in the view of the investigator or medical monitor would compromise the safety of the subject or affect his/her ability to fulfill the protocol visit schedule or visit requirements
2. Subject has a positive drug screen for drugs of abuse at study entry
3. Subject is currently pregnant. breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration



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 5mg/10mg
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 10mg/10mg
Product Code: ALKS 3831
Pharmaceutical Form: Film-coated tablet
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-
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-

Product Name: ALKS 3831 15mg/10mg
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 20mg/10mg
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 numbe

Primary Outcome(s)

Secondary Objective: None

Main Objective: To evaluate the long term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder.

Primary end point(s): Frequency of serious and non-serious adverse events

Timepoint(s) of evaluation of this end point: At monthly visits 1-25: 2, 3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 18, 20, 21, 23, 24
At monthly visits 26-50:
26, 27, 29, 30, 32, 33, 35, 36, 38, 39, 41, 42, 44, 45, 47, 48
At quarterly visits 1-25: 4, 7, 10, 13, 16, 19, 22, 25
At quarterly visits 26-50: 28, 31, 34, 37, 40, 43, 46

Secondary Outcome(s)

Secondary end point(s): Change from baseline in body weight and
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale

Timepoint(s) of evaluation of this end point: at each visit

Secondary ID(s)

2017-000918-36-BG

ALK3831-A308

Source(s) of Monetary Support

Alkermes Inc

Ethics review

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