| 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 evaluate the long-term safety and tolerability of SPD489 (50 and 70mg/day) for the treatment of BED in adults 18-55 years of age (inclusive at the time of consent for the respective antecedent SPD489 BED trial). Long-term safety will be described using:
1. Occurrence of TEAEs.
2. Response to the Columbia Suicide Severity Rating Scale (C-SSRS).
3. Specific evaluation of blood pressure and pulse, weight and waist circumference, clinical laboratory evaluations, and ECG results.
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| E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the effect of SPD489 on the following clinical experience outcomes (including efficacy and quality of life [QoL]):
1. The global impressions of BED improvement as measured by the Clinical Global Impressions of Improvement (CGI-I) scale.
2. The response in binge eating behavior as measured by Eating Disorder Questionnaire (EDE-Q).
3. QoL as measured by the EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L).
Exploratory Objectives:
1. To explore the utilization of healthcare resources in subjects with moderate to severe BED using the Patient Resource Utilization Questionnaire for Binge Eating Disorder (PRUQ BED).
2. To explore the role of additional parameters of interest in the treatment of BED. Potential parameters that may be studied include, but are not limited to, C-reactive protein (CRP), leptin, and ghrelin. |
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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 inclusion criteria (including test results) are confirmed.
All subjects must meet the following criteria:
• Subject has completed 1 of the respective antecedent SPD489 BED trials.
• 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 from the antecedent trial.
• Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
• Subject has a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by physical examination findings, clinical laboratory test results, ECG results, or vital sign results that would preclude treatment with SPD489.
• Subject has an understanding, ability, and willingness to fully comply with study related procedures and restrictions.
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| E.4 | Principal exclusion criteria |
Subjects that have a gap in participation of 30 days or more from completion of the antecedent study Follow-up Visit are excluded from the study if any of the following criteria are met:
• Subject has current diagnosis of bulimia nervosa or anorexia nervosa, confirmed by SCID-I Module H.
• 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).
Subjects are excluded from the study if any of the following exclusion criteria are met:
• 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 Diagnostic Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (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 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.
• Subjects with a history of moderate to severe hypertension or an average (of 3 readings) resting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at study entry. 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 more at the time of the Screening Visit (Visit -1) are allowed.
• Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious disease 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 complying with the protocol. Mild, stable asthma is not exclusionary.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
• The number and percentage of TEAEs
• Response to the C-SSRS
• Specific evaluation of blood pressure and pulse, weight and waist circumference, BMI, clinical laboratory evaluations, and ECG results.
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
• TEAEs, C-SSRS, BP/Pulse, Weight: Visits Scr/0-17
• Waist Circumference: Visits Scr/0, 4, 8, 12, 16/ET
• BMI: Visits Scr/0
• Labs: Scr/0, 6, 9, 16/ET
• ECG: Scr/0-4, 8, 12, 16/ET-17 |
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| E.5.2 | Secondary end point(s) |
• CGI-I
• EDE-Q
• EQ-5D-5L |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
• CGI-I: Visits 1- 16/ET
• EDE-Q: Visits 5 – 16/ET
• EQ-5D-5L: Visits 0, 8 and 16/ET
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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 | No |
| 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 | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| Open-label, Dose Optimization followed by 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 | No |
| E.8.2.3 | Other | No |
| 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 | 7 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 32 |
| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | 9 |
| 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 | 9 |
| E.8.9.2 | In all countries concerned by the trial days | 9 |
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