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Trial record 51 of 593 for:    binge eating disorder

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

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: NCT01657019
Recruitment Status : Completed
First Posted : August 3, 2012
Results First Posted : December 15, 2015
Last Update Posted : December 13, 2018
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 Binge Eating Disorder
Intervention Drug: Lisdexamfetamine dimesylate
Enrollment 604
Recruitment Details 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  
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 604
Completed 369
Not Completed 235
Reason Not Completed
Withdrawal by Subject             65
Adverse Event             55
Lost to Follow-up             48
Protocol Violation             6
Lack of Efficacy             3
Not Specified             58
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 599
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 599 participants
39.0  (9.98)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 599 participants
< 40 years 301
>/= 40 years 298
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 599 participants
Female
521
  87.0%
Male
78
  13.0%
1.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set was 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 599
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 84.5
Serious TEAEs 2.8
2.Primary Outcome
Title Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)
Hide Description Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were “yes,” the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were “no,” then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.
Time Frame 53 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 597
Measure Type: Number
Unit of Measure: participants
Suicidal behavior 0
Active suicidal ideation 2
Non-suicidal self-injurious behavior 3
3.Secondary Outcome
Title Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale
Hide Description The CGI rating scales permitted the global evaluation of a participant’s condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant’s condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a ‘not assessed’ option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation.
Time Frame Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 597
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Visit 1 (Week 1), n=589
53.7
(49.6 to 57.7)
Visit 4 (Week 4), n=572
88.5
(85.8 to 91.1)
Visit 9 (Week 24), n=466
92.7
(90.3 to 95.1)
Visit 16 (Week 52), n=369
95.4
(93.2 to 97.5)
End of Treatment, n=597
89.9
(87.5 to 92.3)
4.Secondary Outcome
Title Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)
Hide Description The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline.
Time Frame Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 597
Mean (Standard Deviation)
Unit of Measure: units on a scale
Visit 4 (Week 4), n=483 -1.66  (1.156)
Visit 9 (Week 24), n=391 -1.95  (1.271)
Visit 16 (Week 52), n=314 -1.95  (1.261)
End of Treatment, n=503 -1.90  (1.284)
5.Secondary Outcome
Title Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility
Hide Description The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Time Frame End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 555
Measure Type: Number
Unit of Measure: percentage of participants at ET
I have no problems in walking about 91.2
I have slight problems in walking about 6.8
I have moderate problems in walking about 1.4
I have severe problems in walking about 0.4
I am unable to walk about 0.2
6.Secondary Outcome
Title Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care
Hide Description The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Time Frame End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 555
Measure Type: Number
Unit of Measure: percentage of participants at ET
I have no problems washing or dressing myself 97.1
I have slight problems washing or dressing myself 1.8
Moderate problems washing or dressing myself 0.7
I have severe problems washing or dressing myself 0.2
I am unable to wash or dress myself 0.2
7.Secondary Outcome
Title Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities
Hide Description The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Time Frame End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 555
Measure Type: Number
Unit of Measure: percentage of participants at ET
I have no problems doing my usual activities 88.5
I have slight problems doing my usual activities 8.3
Moderate problems doing my usual activities 2.2
I have severe problems doing my usual activities 0.9
I am unable to do my usual activities 0.2
8.Secondary Outcome
Title Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort
Hide Description The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Time Frame End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 555
Measure Type: Number
Unit of Measure: percentage of participants at ET
I have no pain or discomfort 71.2
I have slight pain or discomfort 20.9
I have moderate pain or discomfort 7.0
I have severe pain or discomfort 0.9
I have extreme pain or discomfort 0
9.Secondary Outcome
Title Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression
Hide Description The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Time Frame End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was 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.
Arm/Group Title All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 555
Measure Type: Number
Unit of Measure: percentage of participants at ET
I am not anxious or depressed 75.9
I am slightly anxious or depressed 18.7
I am moderately anxious or depressed 4.5
I am severely anxious or depressed 0.9
I am extremely anxious or depressed 0
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were assessed for the 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.
 
Arm/Group Title All Participants
Hide Arm/Group Description 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.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   17/599 (2.84%) 
Cardiac disorders   
Acute coronary syndrome  1  1/599 (0.17%) 
Supraventricular tachycardia  1  1/599 (0.17%) 
Ear and labyrinth disorders   
Tinnitus  1  1/599 (0.17%) 
Gastrointestinal disorders   
Intestinal perforation  1  1/599 (0.17%) 
General disorders   
Chest pain  1  1/599 (0.17%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/599 (0.17%) 
Cholecystitis acute  1  2/599 (0.33%) 
Cholecystitis  1  1/599 (0.17%) 
Infections and infestations   
Pneumonia  1  1/599 (0.17%) 
Gastroenteritis viral  1  1/599 (0.17%) 
Helicobacter infection  1  1/599 (0.17%) 
Diverticulitis  1  1/599 (0.17%) 
Injury, poisoning and procedural complications   
Hip fracture  1  1/599 (0.17%) 
Road traffic accident  1  1/599 (0.17%) 
Lower limb fracture  1  1/599 (0.17%) 
Investigations   
Liver function test abnormal  1  1/599 (0.17%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  1/599 (0.17%) 
Psychiatric disorders   
Adjustment disorder with anxiety  1  1/599 (0.17%) 
Anxiety  1  1/599 (0.17%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/599 (0.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
All Participants
Affected / at Risk (%)
Total   447/599 (74.62%) 
Cardiac disorders   
Tachycardia  1  14/599 (2.34%) 
Gastrointestinal disorders   
Constipation  1  41/599 (6.84%) 
Diarrhoea  1  26/599 (4.34%) 
Dry mouth  1  163/599 (27.21%) 
Nausea  1  41/599 (6.84%) 
Toothache  1  12/599 (2.00%) 
Vomiting  1  15/599 (2.50%) 
General disorders   
Fatigue  1  28/599 (4.67%) 
Feeling jittery  1  30/599 (5.01%) 
Irritability  1  36/599 (6.01%) 
Infections and infestations   
Gastroenteritis  1  14/599 (2.34%) 
Gastroenteritis viral  1  18/599 (3.01%) 
Influenza  1  16/599 (2.67%) 
Nasopharyngitis  1  53/599 (8.85%) 
Sinusitis  1  35/599 (5.84%) 
Upper respiratory tract infection  1  68/599 (11.35%) 
Urinary tract infection  1  27/599 (4.51%) 
Investigations   
Blood pressure increased  1  26/599 (4.34%) 
Heart rate increased  1  15/599 (2.50%) 
Weight decreased  1  19/599 (3.17%) 
Metabolism and nutrition disorders   
Decreased appetite  1  36/599 (6.01%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  16/599 (2.67%) 
Back pain  1  16/599 (2.67%) 
Nervous system disorders   
Dizziness  1  21/599 (3.51%) 
Headache  1  79/599 (13.19%) 
Hypoaesthesia  1  15/599 (2.50%) 
Paraesthesia  1  14/599 (2.34%) 
Psychiatric disorders   
Anxiety  1  30/599 (5.01%) 
Bruxism  1  35/599 (5.84%) 
Initial insomnia  1  25/599 (4.17%) 
Insomnia  1  74/599 (12.35%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  16/599 (2.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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
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 )
First Submitted: August 1, 2012
First Posted: August 3, 2012
Results First Submitted: October 5, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 13, 2018