This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Long-term Safety of SPD489 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:
NCT01760993
First received: January 2, 2013
Last updated: May 1, 2014
Last verified: May 2014
History of Changes
Results First Received: May 1, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: SPD489

  Participant Flow
  Hide Participant Flow

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 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

Participant Flow:   Overall Study
    SPD489
STARTED   0 
COMPLETED   0 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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 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

Baseline Measures
   SPD489 
Overall Participants Analyzed 
[Units: Participants]
 		 0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks   [ Time Frame: Basline and 52 weeks ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 2

3.  Primary:   Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Up to 52 weeks ]
  Show Outcome Measure 3

4.  Primary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 4

5.  Primary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 5

6.  Primary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 6

7.  Primary:   Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 7

8.  Primary:   Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 8

9.  Primary:   Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale   [ Time Frame: Baseline and week 52 ]
  Show Outcome Measure 12

13.  Secondary:   Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale   [ Time Frame: Up to 52 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 14


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01760993     History of Changes
Other Study ID Numbers: SPD489-336
2012-003920-18 ( EudraCT Number )
Study First Received: January 2, 2013
Results First Received: May 1, 2014
Last Updated: May 1, 2014