Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: November 3, 2015
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
  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
Participants were recruited between 12-Nov-2012 and 19-June-2013 and locations included medical clinics & research centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PLACEBO Placebo matching SPD489 capsule administered orally, once-daily, for up to 12 weeks.
SPD489 SPD489 capsule 30 (titration purpose only), 50 or 70 milligram (mg) administered orally, once-daily for up to 12 weeks once the optimal dose is reached.

Participant Flow:   Overall Study
    PLACEBO   SPD489
STARTED   191   192 
Treated   187   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
  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.
Safety Analysis Set was used for Baseline Measures. The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Four participants did not receive investigational product, therefore n=379.

Reporting Groups
  Description
PLACEBO Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Total Total of all reporting groups

Baseline Measures
    PLACEBO   SPD489   Total
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)   [ Time Frame: Baseline and Visit 8 (Weeks 11-12) ]

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

3.  Secondary:   Percentage 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 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 Week 12/Early termination (ET) ]

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

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

9.  Secondary:   Binge Eating Response   [ Time Frame: Week 12/ET ]

10.  Secondary:   Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)   [ Time Frame: Baseline and Visit 8 (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
  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
No text entered.


  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 Development LLC
phone: +1 866 842 5335


Publications of Results:

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01718483     History of Changes
Other Study ID Numbers: SPD489-343
2012-003309-91 ( EudraCT Number )
Study First Received: October 29, 2012
Results First Received: March 18, 2014
Last Updated: November 3, 2015
Health Authority: United States: Food and Drug Administration