E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
generalised anxiety disorder |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017571 |
E.1.2 | Term | GAD |
|
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 |
Clinical improvement of a GAD measured by means of a decrease of CGI score assessed at the end of the 8-week treatment vs. baseline score |
|
E.2.2 | Secondary objectives of the trial |
- Clinical improvement of a GAD measured by means of a decrease of HAM-A observer rating scale, Zung SAS and STAI self-rating scale scores assessed at the end of the 8-week treatment vs. baseline score - Clinical improvement of depression measured by means of a decrease of HAM-D observer rating scale and Zung SDA self-rating scale scores assessed at the end of the 8-week treatment vs. baseline score - Safety and tolerability of the treatment assessed by means of AEs and clinical laboratory assays - Evaluation of effects on CNS by means of EEG/ERP topography and tomography - Evaluation of hypnotic effects by means of all-night polysomnography - Evaluation of subjective sleep and awakening quality and thymopsychic state by means of SSA, Von Zerssen and VAS scores and psychometry. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Sex: males Age: 18-65 y old Anxiety: GAD newly diagnosed according to the DSM IV F41.1 codification Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study Informed Consent: signed written informed consent prior to inclusion in the study
|
|
E.4 | Principal exclusion criteria |
Physical findings: clinically relevant abnormal physical findings, which could interfere with the objectives of the study Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study Diseases: relevant history of other psychiatric, neurological, renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological or endocrine diseases, that may interfere with the aim of the study Concomitant therapy: any other psychopharmacological agents Investigative drug trials: participation in the evaluation of any drug within 1 month prior to the start of the study |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinical improvement of a GAD measured by means of a decrease of CGI score assessed at the end of the 8-week treatment vs. baseline score |
|
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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
2 treatment groups: ABIO 08/01 5, 10, 20 mg and 10, 20, 40 mg |
|
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 | 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
|
last visit of the last subject undergoing the trial |
|
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 | |
E.8.9.1 | In the Member State concerned days | |