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Open Label Extension in Adults With Binge Eating Disorder (BED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01657019
First received: August 1, 2012
Last updated: November 10, 2015
Last verified: December 2014
History of Changes
Results First Received: October 5, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Binge Eating Disorder
Intervention: Drug: Lisdexamfetamine dimesylate

  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
This was an open-label extension study to evaluate the long-term safety of SPD489 in adults aged 18-55 years with binge eating disorder (BED) who completed 1 of 3 antecedent studies, all of which tested SPD489 for BED (SPD489-208, SPD489-343, or SPD489-344).

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
All Participants Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.

Participant Flow:   Overall Study
    All Participants
STARTED   604 
COMPLETED   369 
NOT COMPLETED   235 
Withdrawal by Subject                65 
Adverse Event                55 
Lost to Follow-up                48 
Protocol Violation                6 
Lack of Efficacy                3 
Not Specified                58 



  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, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.

Reporting Groups
  Description
All Participants Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 		 599 
Age 
[Units: Years]
Mean (Standard Deviation) 		 39.0  (9.98) 
Age, Customized 
[Units: Participants]
 		 
< 40 years   301 
>/= 40 years   298 
Gender 
[Units: Participants]
 		 
Female   521 
Male   78 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety   [ Time Frame: 52 weeks ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: 53 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale   [ Time Frame: Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)   [ Time Frame: Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility   [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care   [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities   [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort   [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression   [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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  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



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01657019     History of Changes
Other Study ID Numbers: SPD489-345
2012-003313-34 ( EudraCT Number )
Study First Received: August 1, 2012
Results First Received: October 5, 2015
Last Updated: November 10, 2015