Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
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ClinicalTrials.gov Identifier: NCT01760993 |
Recruitment Status :
Terminated
(Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.)
First Posted : January 4, 2013
Results First Posted : May 29, 2014
Last Update Posted : May 29, 2014
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Sponsor:
Shire
Information provided by (Responsible Party):
Shire
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Tracking Information | ||||
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First Submitted Date ICMJE | January 2, 2013 | |||
First Posted Date ICMJE | January 4, 2013 | |||
Results First Submitted Date ICMJE | May 1, 2014 | |||
Results First Posted Date ICMJE | May 29, 2014 | |||
Last Update Posted Date | May 29, 2014 | |||
Study Start Date ICMJE | February 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia | |||
Official Title ICMJE | A Phase 3, Long-term, Open-label, Multicenter, 52-week, Flexible-dose Safety Study of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia | |||
Brief Summary | The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable. | |||
Detailed Description | Not required | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Schizophrenia | |||
Intervention ICMJE | Drug: SPD489
Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
Other Name: lisdexamfetamine dimesylate, LDX, Vyvanse
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Study Arms ICMJE | Experimental: SPD489
Intervention: Drug: SPD489
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
2 | |||
Original Estimated Enrollment ICMJE |
638 | |||
Actual Study Completion Date ICMJE | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01760993 | |||
Other Study ID Numbers ICMJE | SPD489-336 2012-003920-18 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Shire | |||
Study Sponsor ICMJE | Shire | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Shire | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |