ClinicalTrials.Veeva

Menu

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Alkermes logo

Alkermes

Status and phase

Completed
Phase 3

Conditions

Schizophrenia

Treatments

Drug: ALKS 3831

Study type

Interventional

Funder types

Industry

Identifiers

NCT02873208
ALK3831-A304

Details and patient eligibility

About

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Enrollment

266 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Agrees to use an acceptable method of contraception for the duration of the study
  • Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
  • Additional criteria may apply

Exclusion criteria

  • Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
  • Subject has a positive test for drugs of abuse at study entry
  • Subject is pregnant, planning to become pregnant, or breastfeeding during the study
  • Additional criteria may apply

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

266 participants in 1 patient group

ALKS 3831
Experimental group
Description:
Oral tablet, daily dosing
Treatment:
Drug: ALKS 3831

Trial documents
2

Trial contacts and locations

45

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems