| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss behaviors of bulimia nervosa. Though currently listed in the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) appendix as a disorder provided for further study, it has been recommended that BED be formally included as an eating disorder in DSM-V. |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To demonstrate the efficacy of SPD489 compared with placebo in adults (18-55 years of age inclusive) with moderate to severe BED at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary. |
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| E.2.2 | Secondary objectives of the trial |
Key Secondary Objectives
1. To demonstrate the efficacy of SPD489 compared with placebo on the global impressions of BED improvement as measured by the CGI-I scale at Visit 8 (Week 12)/ET.
2. To demonstrate the efficacy of SPD489 compared with placebo on 4-week cessation from binge eating behavior (free from binge episodes in the respective period) for the last 28 days prior to Visit 8 (Week 12)/ET.
3. To demonstrate the efficacy of SPD489 compared with placebo on the percent change from baseline (Visit 0) in body weight at Visit 8 (Week 12).
4. To demonstrate the efficacy of SPD489 on obsessive/compulsive binge eating symptoms compared to placebo at Visit 8 (Week 12) as measured by the change from baseline (Visit 0) in the Y-BOCS-BE total score.
5. To demonstrate the efficacy of SPD489 compared with placebo on the change from baseline (Visit -1) in TG from fasted samples at Visit 8 (Week 12).
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:
• Subject is between 18-55 years of age (or age of majority if greater than 18 years of age, as defined by local regulations), inclusive, at the time of consent.
• Subject meets DSM-IV-TR criteria for a diagnosis of BED.
• Subject’s BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as documented in the subject’s binge diary. A binge day is a day during which at least 1 binge eating episode occurs.
• Subject must have a CGI-S score superior or equal (>=) to 4 at the Screening Visit (Visit -1) and Baseline Visit (Visit 0).
• Subject has a BMI of superior or equal (>=) to 18 and inferior or equal (<=) to 45 at the Screening Visit (Visit -1) and the Baseline Visit (Visit 0).
• Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
• Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
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| E.4 | Principal exclusion criteria |
Subjects are excluded from the study if any of the following exclusion criteria are met:
• Subject has current diagnosis of bulimia nervosa or anorexia nervosa as defined by the SCID-I eating disorders module.
• Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED that began within the 3 months prior to the Screening Visit (Visit -1). Subjects who are receiving psychotherapy or weight loss support that was initiated greater or equal (>=) to 3 months prior to the Screening Visit (Visit -1) will be allowed to continue to receive psychotherapy or weight loss support during the study only if they agree to not make any changes in the frequency or nature of their psychotherapy or weight loss support during the course of this study.
• Subject has a current comorbid Axis I or Axis II psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms (note: subjects with mild mood or anxiety symptoms that do not meet criteria for Axis I disorder, do not require treatment based on the investigator’s assessment, and do not confound efficacy or safety assessments in the opinion of the examining investigator may be included).
• Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
• Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator.
• Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder in accordance with DSM-IV-TR criteria. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded. Nicotine dependence is not exclusionary.
• Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis, an infectious process requiring antibiotics, or diabetes), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Subject will be excluded if he or she has any additional condition(s) that in the investigator’s opinion would prohibit the subject from completing the study or would not be in the best interest of the subject to participate in the study. This would include any significant illness or unstable medical condition that could lead to difficulty in complying with the protocol. Mild, stable asthma is not exclusionary.
• Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.
• Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
• Subject has any clinically significant ECG prior to the Baseline Visit (Visit 0).
• Subject has any clinically significant laboratory abnormality prior to the Baseline Visit (Visit 0). Subjects with hypokalemia at the Screening Visit or prior to the Baseline Visit (Visit 0) will be excluded.
• Subject has a history of moderate or severe hypertension or has a resting average (of 3 readings) sitting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at the Screening Visit (Visit -1) and/or Baseline Visit (Visit 0). NOTE: Subjects with mild (Stage 1), well-controlled hypertension on a stable antihypertensive treatment regimen, defined as having maintained the current dose for a period of at least 3 months or longer at the time of the Screening Visit (Visit -1), are allowed.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| Change from baseline to Visit 8 (Weeks 11 and 12) in the number of binge days per week. Baseline is defined as the weekly average of the number of binge days per week for the 14 days prior to the Baseline Visit (Visit 0). |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Subject Daily Diary: Visit 0 and Visit 8 |
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| E.5.2 | Secondary end point(s) |
Key Secondary Efficacy Endpoints
1. The CGI-I at Visit 8 (Week 12)/ET.
2. Proportion of subjects with 4-week cessation from binge eating at for the last 28 days prior to Visit 8/ET.
3. The percent change in body weight from Baseline Visit (Visit 0) to Visit 8 (Week 12).
4. The change from baseline (Visit 0) in Y-BOCS-BE at Visit 8 (Week 12).
5. The change from baseline (Visit -1) in TG from fasted samples at Visit 8 (Week 12).
Secondary Efficacy Endpoints
1. The change from screening (Visit -1) in TC from fasted samples at Visit 8 (Week 12).
2. The change from screening (Visit -1) in HbA1c from fasted samples at Visit 8 (Week 12).
3. The change from baseline in the number of binge episodes per week at Visit 8 (Weeks 11 and 12). Baseline is defined as the weekly average of the number of binge episodes per week for the 14 days prior to the Baseline Visit (Visit 0).
4. The response status in binge eating behavior at Visit 8 (Weeks 11 and 12)/ET based on the number of binge episodes per week.
5. The change from baseline (Visit 0) in Eating Inventory at Visit 8 (Week 12).
6. The change from baseline (Visit 0) in the BES at Visit 8 (Week 12).
7. The change from baseline (Visit 0) in the FrSBe at Visit 8 (Week 12).
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Key Secondary Efficacy Endpoints
CGI-I: Visit 8/ET
Subject Daily Diary: V6-V8/ET
Weight: Visit 0 and Visit 8
Y-BOCS-BE: Visit 0 and Visit 8
TG: Visit -1 and Visit 8
Secondary Efficacy Endpoints
TC: Visit -1 and Visit 8
HbA1c: Visit -1 and Visit 8
Subject Daily Diary: Visit 0 and Visit 8
Subject Daily Diary: Visit 8
Eating Inventory: Visit 0 and Visit 8
BES: Visit 0 and Visit 8
FrSBe: Visit 0 and Visit 8
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | Yes |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| Dose-optimization followed by Dose-maintenance |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 17 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| The end of the trial is signified by the last patient finishing the last visit (the Follow-up Visit) of the trial. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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