A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
|ClinicalTrials.gov Identifier: NCT01626456|
Recruitment Status : Completed
First Posted : June 22, 2012
Results First Posted : October 27, 2016
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: ALKS 9072, Low Drug: ALKS 9072, High||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||478 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
|Experimental: ALKS 9072, Low||
Drug: ALKS 9072, Low
IM injection, given monthly
|Experimental: ALKS 9072, High||
Drug: ALKS 9072, High
IM injection, given monthly
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 52 weeks ]This measure includes incidences >5%.
- Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S) [ Time Frame: 52 weeks ]The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data.
- Discontinuation From Study Due to Adverse Events (AEs) [ Time Frame: 52 weeks ]Number of subjects who discontinued the study due to AE.
- Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 52 weeks ]The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.
- Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests [ Time Frame: 52 weeks ]Includes incidence >2% but <5%.
- Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores [ Time Frame: 52 weeks ]This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626456
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|Study Director:||Robert Risinger, MD||Alkermes, Inc.|