Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

• ClinicalTrials.gov Identifier: NCT01760993
• Recruitment Status: Terminated
• First Posted: January 4, 2013
• Results First Posted: May 29, 2014
• Last Update Posted: May 29, 2014
• Sponsor: Shire
• Information provided by (Responsible Party): Shire

Tracking Information

• First Submitted Date: January 2, 2013
• First Posted Date: January 4, 2013
• Results First Submitted Date: May 1, 2014
• Results First Posted Date: May 29, 2014
• Last Update Posted Date: May 29, 2014
• Study Start Date: February 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 2, 2013)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks [ Time Frame: Basline and 52 weeks ]
• Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
• Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 52 weeks ]
• Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
• Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
• Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
• Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
• Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
• Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01760993 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 2, 2013)

• Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
• Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
• Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 52 ]
• Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 52 weeks ]
• Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Schizophrenia

Intervention

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

Study Arms

Experimental: SPD489

Intervention: Drug: SPD489

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 3, 2013): 2
• Original Estimated Enrollment (submitted: January 2, 2013): 638
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 to 65 years of age
• Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
• Fixed home/place of residence and can be reached by telephone
• On a stable dose of antipsychotic medications
• Able to swallow capsules

Exclusion Criteria:

• -Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
• Treated with clozapine in past 30 days
• Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
• History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
• Uncontrolled hypertension
• History of thyroid disorder that has not been stabilized on thyroid medication
• Glaucoma
• Pregnant or nursing
• Subject has received an investigational product or participated in a clinical study within 30 days

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01760993
• Other Study ID Numbers: SPD489-336; 2012-003920-18 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Shire
• Study Sponsor: Shire
• Collaborators: Not Provided

Investigators

• Principal Investigator: Stephen R. Marder, MD; Desert Pacific Mental Illness Research, Education, and Clinical Center

• PRS Account: Shire
• Verification Date: May 2014