Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With 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: NCT01760993
Recruitment Status : Terminated (Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.)
First Posted : January 4, 2013
Results First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: SPD489
Enrollment 2
Recruitment Details  
Pre-assignment Details Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489
Hide Arm/Group Description 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
Period Title: Overall Study
Started 0
Completed 0
Not Completed 0
Arm/Group Title SPD489
Hide Arm/Group Description 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
Overall Number of Baseline Participants 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
<=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
Female
Male
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks
Hide Description [Not Specified]
Time Frame Basline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description [Not Specified]
Time Frame Up to 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Primary Outcome
Title Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Primary Outcome
Title Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Hide Description [Not Specified]
Time Frame Baseline and week 52
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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Hide Description [Not Specified]
Time Frame Up to 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 52 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
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 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
Hide Arm/Group Description 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
All-Cause Mortality
SPD489
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SPD489
Affected / at Risk (%)
Total   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
Affected / at Risk (%)
Total   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: NCT01760993     History of Changes
Other Study ID Numbers: SPD489-336
2012-003920-18 ( EudraCT Number )
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: May 1, 2014
Results First Posted: May 29, 2014
Last Update Posted: May 29, 2014