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

NCT01760993 | Terminated Phase 3 Results DMC

• 2 other identifiers: SPD489-3362012-003920-18
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Keywords

Not Required

Outcome Measures

Primary Outcomes (9)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks

  Basline and 52 weeks

• Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks

  Baseline and 52 weeks

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Up to 52 weeks

• Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks

  Baseline and 52 weeks

• Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks

  Baseline and 52 weeks

• Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks

  Baseline and 52 weeks

• Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks

  Baseline and 52 weeks

• Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks

  Baseline and 52 weeks

• Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks

  Baseline and 52 weeks

Secondary Outcomes (5)

• Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks

  Baseline and 52 weeks

• Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks

  Baseline and 52 weeks

• Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale

  Baseline and week 52

• Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale

  Up to 52 weeks

• Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks

  Baseline and 52 weeks

Study Arms (1)

SPD489

EXPERIMENTAL

Drug: SPD489

Interventions

SPD489 DRUG

Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks

Also known as: lisdexamfetamine dimesylate, LDX, Vyvanse

SPD489

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shire: lead

Study Sites (2)

SP Research PLLC/Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, 73112, United States

Location

CRI Lifetree

Philadelphia, Pennsylvania, 19139, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 4, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 22, 2021
• Results First Posted: May 29, 2014

Record last verified: 2021-05

Locations

US (2)