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A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

NCT01493726 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-08-29

No results posted yet for this study

Summary

This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.

Conditions

Interventions

DRUG

ALKS 9072, Low dose

IM injection, given monthly

DRUG

ALKS 9072, Med dose

IM injection, given monthly

DRUG

ALKS 9072, High dose

IM injection, given monthly

DRUG

Placebo

Dosed matched placebo IM injection, given monthly

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Alkermes Medical Director, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493726 on ClinicalTrials.gov