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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003918-14 | EudraCT Number |
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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 whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD489 40mg | Experimental |
| |
| SPD489 100mg | Experimental |
| |
| SPD489 160mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD489 40mg | Drug | Oral administration of 40 mg once-daily for up to 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks | Baseline and 12 weeks | |
| Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hills Clinical Research | Irving | Texas | 75062 | United States |
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD489 40mg | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks |
| FG001 | SPD489 100mg | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks |
| FG002 | SPD489 160mg | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks |
| FG003 | Placebo | Placebo: Oral administration once-daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | SPD489 40mg | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks |
| BG001 | SPD489 100mg | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 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 Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
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Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPD489 40mg | SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks |
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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 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| SPD489 100mg | Drug | Oral administration of 100 mg once-daily for up to 12 weeks |
|
|
| SPD489 160mg | Drug | Oral administration of 160 mg once-daily for up to 12 weeks |
|
|
| Placebo | Drug | Oral administration once-daily for 12 weeks |
|
| Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks | Baseline and 12 weeks |
| Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks | Baseline and 12 weeks |
| Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks | Baseline and 12 weeks |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks | Baseline and 12 weeks |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks | Baseline and 12 weeks |
| Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks | Baseline and 12 weeks |
| Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks | Baseline and 12 weeks |
| Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale | Baseline and week 12 |
| Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale | Up to 12 weeks |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 12 weeks |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks | Baseline and 12 weeks |
| Ambulatory Blood Pressure Monitoring (ABPM) | Baseline and Weeks 4 and 10 |
| BG002 | SPD489 160mg | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks |
| BG003 | Placebo | Placebo: Oral administration once-daily for 12 weeks |
| BG004 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Region of Enrollment |
|
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
| OG003 | Placebo | Placebo: Oral administration once-daily for 12 weeks |
|
| Secondary | Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 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 12 |
|
|
| 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 12 weeks |
|
|
| Secondary | 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 12 weeks |
|
|
| Secondary | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and 12 weeks |
|
|
| Secondary | Ambulatory Blood Pressure Monitoring (ABPM) | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | Baseline and Weeks 4 and 10 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | SPD489 100mg | SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks | 0 | 0 | 0 | 0 |
| EG002 | SPD489 160mg | SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks | 0 | 0 | 0 | 0 |
| EG003 | Placebo | Placebo: Oral administration once-daily for 12 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 |