Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003920-18 | EudraCT Number |
Not provided
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Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.
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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.
Not required
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD489 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SP Research PLLC/Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | United States | ||
| CRI Lifetree |
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SPD489 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SPD489 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Basline and 52 weeks |
|
|
Not provided
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPD489 | 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 |
Not provided
Not provided
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Philadelphia |
| Pennsylvania |
| 19139 |
| United States |
|
| Sex: Female, Male |
|
| Region of Enrollment |
|
| Primary | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Primary | Columbia-Suicide Severity Rating Scale (C-SSRS) | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Up to 52 weeks |
|
|
| Primary | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Primary | Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Primary | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Primary | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Primary | Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Primary | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Secondary | Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Secondary | Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| Secondary | Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and week 52 |
|
|
| Secondary | Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Up to 52 weeks |
|
|
| Secondary | Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 52 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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.
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |