E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elderly outpatients with primary insomnia, diagnosed according to DSM IV -TR |
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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 |
The main objectives of the study are to compare the hypnotic efficacy and safety of Gaboxadol 5 mg and 10 mg daily with that of placebo over a 4 weeks treatment period in a population of outpatients suffering from primary insomnia. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The patient 1.is able to read and understand the PI sheet.2.has given signed informed consent. 3.is an outpatient who is 65 year of age or older.4.has a usual bedtime between 20:00 and 24:00. 5. suffers from Primary Insomnia as diagnosed according to DSM IV-TRTM. 6.has a self-reported total sleep time < 6.0 hours and a self-reported time to sleep onset of 45 minutes or more on at least 4 out of 7 nights. 7. is, in the investigator’s opinion, otherwise healthy, or any existing disease does not interfere with patient’s participation in the study. 9.is willing to abstain from alcohol 5 hours prior to bedtime and during the night throughout study period.
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E.4 | Principal exclusion criteria |
Patient 1.has a history of or current abuse or dependence on any substance with abuse potential according to DSM-IV-TRTM. 2.has a current diagnosis of personality disorder according to DSM-IV-TRTM. 3.Any psychotic disorder as defined in DSM-IV-TRTM, current or history thereof.4.has any other major current Axis I diagnosis other than primary insomnia (operationalised by the MINI).5. has any of the following conditions:sleep apnoe syndrome, restless leg syndrome,severe or acute respiratory failure,myasthenia gravis,History of muscle spasm or epileptic seizure 7.Use of disallowed recent/concomitant therapy: 10.History of severe drug allergy or hypersensitivity, or known hypersensitivity to Gaboxadol or clinically relevant lactose intolerance. 11.has a known positive HIV test. 12. Diseases/medication, which, judged by the investigator, could interfere with the assessments of safety, tolerability or efficacy. 13. Unstable serious illness and/or serious sequelae thereof, including liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, metabolic disturbances or if leading cause of insomnia is pain. (If there is history of such disease but the condition has been stable for at least one year and is judged by the investigator not to lead to an unsafe inclusion and not to interfere with the patient’s participation in the study, the patient may be included).
14. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any other reasons. 15. Laboratory values at screening outside the normal ranges, considered by the investigator to be clinically significant 16. Patient has a positive urine drug screen 17. Previous participation in this study or another Gaboxadol study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be based on weekly (week 1-4) means of change in subjective sleep total time compared to baseline between each gaboxadol treatment group and placebo. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 patient visit is foreseen for 27/09/2005 |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |