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SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

This study has been terminated.
(Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized)
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01760889
First received: January 2, 2013
Last updated: May 1, 2014
Last verified: May 2014
Results First Received: May 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: SPD489 low dose range (40mg, 80mg, and 100mg)
Drug: SPD489 high dose range (120mg, 140mg and 160mg)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Reporting Groups
  Description
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
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
Placebo Placebo: One capsule a day for 26 weeks

Participant Flow:   Overall Study
    SPD489 Low Dose Range     SPD489 High Dose Range     Placebo  
STARTED     0     0     0  
COMPLETED     0     0     0  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Reporting Groups
  Description
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
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
Placebo Placebo: One capsule a day for 26 weeks
Total Total of all reporting groups

Baseline Measures
    SPD489 Low Dose Range     SPD489 High Dose Range     Placebo     Total  
Number of Participants  
[units: participants]
  0     0     0     0  
Age  
[units: participants]
       
<=18 years                  
Between 18 and 65 years                  
>=65 years                  
Gender  
[units: participants]
       
Female                  
Male                  
Region of Enrollment  
[units: participants]
       
United States                  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

2.  Secondary:   Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

3.  Secondary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

4.  Secondary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

5.  Secondary:   Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

6.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

7.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

8.  Secondary:   Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

9.  Secondary:   Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale   [ Time Frame: Baseline and week 26 ]

10.  Secondary:   Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale   [ Time Frame: Up to 26 weeks ]

11.  Secondary:   Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

12.  Secondary:   Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]

13.  Secondary:   Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Up to 26 weeks ]

14.  Secondary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks   [ Time Frame: Baseline and 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire
phone: +1 866 842 5335


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01760889     History of Changes
Other Study ID Numbers: SPD489-335, 2012-003919-57
Study First Received: January 2, 2013
Results First Received: May 1, 2014
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration