Trial record 3 of 6 for:    Lisdexamfetamine binge eating

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01718483
First received: October 29, 2012
Last updated: August 4, 2014
Last verified: August 2014
Results First Received: March 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Binge Eating Disorder
Interventions: Drug: SPD489 (Lisdexamfetamine dimesylate)
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PLACEBO Administered once-daily, orally, for up to 12 weeks
SPD489 50 or 70 mg administered orally, once-daily for up to 12 weeks

Participant Flow:   Overall Study
    PLACEBO     SPD489  
STARTED     191     192  
COMPLETED     157     158  
NOT COMPLETED     34     34  
Withdrawal by Subject                 14                 12  
Adverse Event                 5                 12  
Lost to Follow-up                 8                 3  
Protocol Violation                 4                 2  
Not specified                 1                 4  
Pregnancy                 1                 1  
Lack of Efficacy                 1                 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.
Safety Analysis Set was used for Baseline Measures. The Safety Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Four subjects did not receive investigational product, therefore n=379.

Reporting Groups
  Description
PLACEBO Administered once-daily, orally, for up to 12 weeks
SPD489 50 or 70 mg administered orally, once-daily for up to 12 weeks
Total Total of all reporting groups

Baseline Measures
    PLACEBO     SPD489     Total  
Number of Participants  
[units: participants]
  187     192     379  
Age  
[units: Years]
Mean ± Standard Deviation
  37.6  ± 10.21     38.5  ± 10.4     38.1  ± 10.3  
Age, Customized  
[units: Participants]
     
<40 years     102     98     200  
>=40 years     85     94     179  
Gender  
[units: Participants]
     
Female     163     165     328  
Male     24     27     51  
Region of Enrollment  
[units: Participants]
     
GERMANY     2     1     3  
SPAIN     5     5     10  
SWEDEN     15     13     28  
UNITED STATES     165     173     338  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12   [ Time Frame: Baseline and Visit 8 which spans weeks 11/12 ]

2.  Secondary:   Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores   [ Time Frame: Up to 12 weeks ]

3.  Secondary:   Percent of Participants With a 4-Week Cessation From Binge Eating   [ Time Frame: Up to 12 weeks ]

4.  Secondary:   Percent Change From Baseline in Body Weight (kg) at Week 12   [ Time Frame: Baseline and week 12 ]

5.  Secondary:   Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12   [ Time Frame: Baseline and week 12 ]

6.  Secondary:   Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks   [ Time Frame: Baseline and up to 12 weeks ]

7.  Secondary:   Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks   [ Time Frame: Baseline and up to 12 weeks ]

8.  Secondary:   Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks   [ Time Frame: Baseline and up to 12 weeks ]

9.  Secondary:   Binge Eating Response   [ Time Frame: Up to 12 weeks ]

10.  Secondary:   Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12   [ Time Frame: Baseline and Visit 8 Which Spans Weeks 11/12 ]

11.  Secondary:   Change From Baseline in Eating Inventory Scores at Week 12   [ Time Frame: Baseline and week 12 ]

12.  Secondary:   Change From Baseline in Binge Eating Scale (BES) Score at Week 12   [ Time Frame: Baseline and week 12 ]

13.  Secondary:   Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12   [ Time Frame: Baseline and week 12 ]

14.  Secondary:   EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility   [ Time Frame: Up to 12 weeks ]

15.  Secondary:   EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care   [ Time Frame: Up to 12 weeks ]

16.  Secondary:   EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities   [ Time Frame: Up to 12 weeks ]

17.  Secondary:   EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort   [ Time Frame: Up to 12 weeks ]

18.  Secondary:   EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression   [ Time Frame: Up to 12 weeks ]

19.  Secondary:   Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Up to 12 weeks ]

20.  Secondary:   Amphetamine Cessation Symptom Assessment (ACSA) Total Score   [ Time Frame: Up to 12 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
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  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 Development LLC
phone: +1 866 842 5335


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01718483     History of Changes
Other Study ID Numbers: SPD489-343, 2012-003309-91
Study First Received: October 29, 2012
Results First Received: March 18, 2014
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration