A Phase 1 interventional study of ALKS 9072, Low dose and ALKS 9072, Med dose in Schizophrenia, sponsored by Alkermes, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Alkermes, Inc. · Phase 1, Interventional, and Treatment
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.
Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 88 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Alkermes, Inc. is the lead sponsor of 82 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: ALKS 9072, Low dose
Drug: ALKS 9072, Med dose
Drug: ALKS 9072, High dose
Drug: Placebo
IM injection, given monthly
IM injection, given monthly
IM injection, given monthly
Dosed matched placebo IM injection, given monthly
Maximum concentration in plasma following last dose
Time frame: 4 months
Time to maximum concentration in plasma following last dose
Time frame: 4 months
Area under the plasma concentration time curve over the last dosing interval
Time frame: 4 months
Number of Participants with Adverse Events
Time frame: 4 months
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Alkermes, Inc.