A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626456
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|Study Director:||Robert Risinger, MD||Alkermes, Inc.|