| Primary | Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
| | | |
| Secondary | Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 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 26 | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| 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 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 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 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|
| Secondary | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks | | Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized | Posted | | | | | | Baseline and 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 Low Dose Range | SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once-daily for 4 weeks; then, • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks | | OG001 | SPD489 High Dose Range | SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration, • 40 mg capsule once-daily for 1 week; then • 80 mg capsule once daily for 1 week; then • 120 mg capsule once-daily for 1 week, then, • 140 mg capsule once-daily for 2 weeks, then • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks | | OG002 | Placebo | Placebo: One capsule a day for 26 weeks |
|