E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
severe chronic Anorexia Nervosa |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002649 |
E.1.2 | Term | Anorexia nervosa |
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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 reveal through a pilot trial if treatment of patients with severe chronic Anorexia Nervosa with cannabinoid type 1 receptor agonist has significant effect on weight
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E.2.2 | Secondary objectives of the trial |
To reveal through a pilot trial if treatment of patients with severe chronic Anorexia Nervosa with cannabinoid type 1 receptor agonist has significant effect on: • Weight gain (primary endpoint) • Eating Disorder Inventory (EDI) scale • Motor and inner restlessness (estimated by accelerometry) • Endocrine parameters
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1 Patients under treatment for AN. 2 Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period. 3 Patients admitted to Department of Endocrinology M or Psychiatric department P which are not expected to be discharged during the study period. 4 Age over 18. 5 Duration of the disease over 5 years.
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E.4 | Principal exclusion criteria |
1 Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression. 2 Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study. 3 Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest). 4 Patients not attending to the weekly controls. 5 If other severe adverse events (SAE) / drug reactions (SADR) are suspected. 6 Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse. 7 Patients with known allergy to dronabinol or sesam oil. 8 Fertile, menstruating women not using safe contraception*. 9 Pregnancy.
* - Patients with chronic AN have per definition amenorrhea and seldom vita sexualis.
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E.5 End points |
E.5.1 | Primary end point(s) |
Weight gain on Marinol (dronabinol / cannabinoid type 1 receptor agonist) therapy |
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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 | No |
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 | No |
E.6.12 | Pharmacoeconomic | No |
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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 last visit of the last subject undergoing 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |