Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Binge Eating Disorder
Interventions:	Drug: Lisdexamfetamine dimesylate Other: Placebo

Participant Flow

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
SPD489 (Open-label Period)	SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
Placebo (Randomized-withdrawal Period)	During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
SPD489 (Randomized-withdrawal Period)	For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26week double-blind randomized-withdrawal phase, participants were followed for 1 week.

Participant Flow for 2 periods

Period 1: Open-label Period (Non-randomized)

	SPD489 (Open-label Period)	Placebo (Randomized-withdrawal Period)	SPD489 (Randomized-withdrawal Period)
STARTED	418	0	0
COMPLETED	275	0	0
NOT COMPLETED	143	0	0
Failure to Meet Randomization Criteria	48	0	0
Withdrawal by Subject	29	0	0
Adverse Event	22	0	0
Lost to Follow-up	20	0	0
Protocol Violation	10	0	0
Pregnancy	1	0	0
Not specified	13	0	0

Period 2: Randomized-withdrawal Period

	SPD489 (Open-label Period)	Placebo (Randomized-withdrawal Period)	SPD489 (Randomized-withdrawal Period)
STARTED	0 ^[1]	138 ^[2]	137 ^[2]
COMPLETED	0	50	102
NOT COMPLETED	0	88	35
Withdrawal by Subject	0	25	9
Lost to Follow-up	0	13	6
Adverse Event	0	0	6
Relapse Criteria Met	0	40	5
Protocol Violation	0	1	2
Pregnancy	0	0	2
Not specified	0	9	5

^[1]	The open-label treatment group is not an arm of the randomized-withdrawal period.
^[2]	The total who started the Placebo and SPD489 arms equals those who completed the open-label period.

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.
The Open-label Safety Population (OSP) was defined as all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment. Seven participants were enrolled but not treated and thus not included in the OSP.

Reporting Groups

	Description
Open-label Safety Population	The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.

Baseline Measures

	Open-label Safety Population
Overall Participants Analyzed [Units: Participants]	411

Age [Units: Years] Mean (Standard Deviation)	38.3 (10.40)

Age, Customized [Units: Participants]
< 40 years of age	217
>/= 40 years of age	194

Gender [Units: Participants]
Female	358
Male	53

Outcome Measures

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1. Primary:

Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) ]

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2. Secondary:

Change From Randomized-Withdrawal Baseline in The Number of Binge Eating Days Per Week During The Randomized-withdrawal Period [ Time Frame: Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38]) ]

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3. Secondary:

Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) ]

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4. Secondary:

Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period [ Time Frame: Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38]) ]

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5. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period [ Time Frame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) ]

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6. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Randomized-withdrawal Period [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) ]

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7. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period [ Time Frame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) ]

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8. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) ]

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9. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period [ Time Frame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) ]

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10. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) ]

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11. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period [ Time Frame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) ]

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12. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) ]

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13. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period [ Time Frame: Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) ]

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14. Secondary:

Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) ]

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15. Secondary:

Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period [ Time Frame: Visit 8 (12 weeks after start of open-label treatment [Week 12]) ]

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16. Secondary:

Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) ]

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17. Secondary:

Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up [ Time Frame: Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose) ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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:

Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT02009163 History of Changes
Other Study ID Numbers:	SPD489-346 2012-004457-88 ( EudraCT Number )
Study First Received:	December 6, 2013
Results First Received:	January 28, 2016
Last Updated:	March 2, 2016