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

• Sponsor: Shire (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01760993
• Collaborator: (none)
• Enrollment: 2
• Locations: 2
• Arm: 1
• Actual Duration (Months): 1.9
• Patient Per Site: 1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: SPD489	Phase 3

Detailed Description

Not required

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPD489	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 Names: lisdexamfetamine dimesylate, LDX, Vyvanse

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks [Basline and 52 weeks]

2. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks [Baseline and 52 weeks]

3. Columbia-Suicide Severity Rating Scale (C-SSRS) [Up to 52 weeks]

4. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks [Baseline and 52 weeks]

5. Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks [Baseline and 52 weeks]

6. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks [Baseline and 52 weeks]

7. Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks [Baseline and 52 weeks]

8. Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks [Baseline and 52 weeks]

9. Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks [Baseline and 52 weeks]

Secondary Outcome Measures

1. Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks [Baseline and 52 weeks]

2. Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks [Baseline and 52 weeks]

3. Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [Baseline and week 52]

4. Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [Up to 52 weeks]

5. Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks [Baseline and 52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SP Research PLLC/Oklahoma Clinical Research Center	Oklahoma City	Oklahoma	United States	73112
2	CRI Lifetree	Philadelphia	Pennsylvania	United States	19139

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01760993
• Other Study ID Numbers: SPD489-336; 2012-003920-18
• First Posted: Jan 4, 2013
• Last Update Posted: Jun 22, 2021
• Last Verified: May 1, 2021

• Keywords provided by Shire: Not Required
• Additional relevant MeSH terms: Schizophrenia; Lisdexamfetamine Dimesylate

Study Results

Participant Flow

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

Arm/Group Title	SPD489
Arm/Group Description	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
Period Title: Overall Study
STARTED	0
COMPLETED	0
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	SPD489
Arm/Group Description	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
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Region of Enrollment () []

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks
Time Frame	Basline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

2. Primary Outcome

Title	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

3. Primary Outcome

Title	Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

4. Primary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

5. Primary Outcome

Title	Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

6. Primary Outcome

Title	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

7. Primary Outcome

Title	Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

8. Primary Outcome

Title	Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

9. Primary Outcome

Title	Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

10. Secondary Outcome

Title	Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

11. Secondary Outcome

Title	Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

12. Secondary Outcome

Title	Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Time Frame	Baseline and week 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

13. Secondary Outcome

Title	Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

14. Secondary Outcome

Title	Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SPD489
Arm/Group Description	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
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title	SPD489
Arm/Group Description	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
All Cause Mortality
	SPD489
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SPD489
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	SPD489
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.