Safety, Efficacy & Tolerability of ALKS3831 in Schizophrenia (308)
Research type
Research Study
Full 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
IRAS ID
236891
Contact name
Ekwere George Umoh
Contact email
Sponsor organisation
Alkermes Inc.
Eudract number
2017-000918-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 28 days
Research summary
This Phase 3 study is an extension to ALK3831-A307 study that will evaluate the long term safety, tolerability and durability of treatment effect of ALKS 3831 in patients with schizophrenia, schizophreniform disorder or bipolar I disorder.
Treatment with ALKS 3831 combines the advantages of the antipsychotic efficacy of olanzapine in treating both schizophrenia and bipolar disorder, with the potential to moderate the known effect of olanzapine treatment of excessive weight gain.
Approximately 500 patients globally will take part in the study. In UK only patients who completed the ALK3831-A307 study will be eligible to participate. If patients agree to roll over into extension study they will receive the study drug for another up to 2 years.
The study will provide valuable safety, tolerability and durability of treatment effect data over the longest treatment duration evaluated so far (up to 3.5 years).
The study drug ALKS 3831 has a form of a film-coated tablet and will be taken once a day by mouth, preferably at bed time. All patients will receive ALKS 3831 in doses 5mg, 10mg, 15mg and 20mg olanzapine combined with 10 mg samidorphan.
The total duration of the study will be up to 25 months and will include a treatment period of up to 24 months and a 4-week safety Follow-up period. After the completion of the follow up period patient will return to their normal standard of care treatment.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0020
Date of REC Opinion
23 Jan 2018
REC opinion
Unfavourable Opinion