Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01738698
Recruitment Status : Terminated (Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.)
First Posted : November 30, 2012
Results First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: SPD489 40mg
Drug: SPD489 100mg
Drug: SPD489 160mg
Drug: Placebo
Enrollment 4
Recruitment Details  
Pre-assignment Details Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks Placebo: Oral administration once-daily for 12 weeks
Period Title: Overall Study
Started 0 0 0 0
Completed 0 0 0 0
Not Completed 0 0 0 0
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo Total
Hide Arm/Group Description SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks Placebo: Oral administration once-daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 0 0
Hide Baseline Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
1.Primary Outcome
Title Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Ambulatory Blood Pressure Monitoring (ABPM)
Hide Description [Not Specified]
Time Frame Baseline and Weeks 4 and 10
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description:
SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo: Oral administration once-daily for 12 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
 
Arm/Group Title SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Hide Arm/Group Description SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks Placebo: Oral administration once-daily for 12 weeks
All-Cause Mortality
SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SPD489 40mg SPD489 100mg SPD489 160mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire
Phone: +1 866 842 5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01738698     History of Changes
Other Study ID Numbers: SPD489-338
2012-003918-14 ( EudraCT Number )
First Submitted: November 28, 2012
First Posted: November 30, 2012
Results First Submitted: May 1, 2014
Results First Posted: May 29, 2014
Last Update Posted: May 29, 2014