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
|
|
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 objective of the study is to obtain 12 month safety data of gaboxadol 10mg in elderly patients. |
|
E.2.2 | Secondary objectives of the trial |
In addition efficacy, withdrawal symptoms and rebound insomnia after long-term gaboxadol treatment will be evaluated. |
|
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 patient information sheet. 2. has given signed informed consent . 3.has completed Study 10403. 4.is an outpatient who is 65 years of age or older. 5.suffers from Primary Insomnia as diagnosed according to DSM IV-TRTM at time of entry into study 10403. 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.the patient is, in the investigator’s opinion, otherwise healthy, or any existing disease does not interfere with patient’s participation in the study. 8.In the clinical opinion of the investigator continued treatment with a hypnotic is indicated. |
|
E.4 | Principal exclusion criteria |
1.Patient has a history of or current abuse or dependence on any substance with abuse potential according to DSM-IV-TRTM (alcohol, hypnotics, and drugs of abuse, but excludes nicotine dependence). 2.Patient has a current diagnosis of personality disorder according to DSM-IV-TRTM.3.Any psychotic disorder as defined in DSM-IV-TRTM, 4.Patient has any other major current Axis I diagnosis other than primary insomnia (operationalised by the MINI). 5.Patient 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 10.History of severe drug allergy or hypersensitivity, or known hypersensitivity to gaboxadol or clinically relevant lactose intolerance. 11.Patient has a known positive HIV test.12.Diseases/medication, which, judged by the investigator, could interfere with the assessments |
|
E.5 End points |
E.5.1 | Primary end point(s) |
General safety and tolerability as monitored by AE/SAE reporting, physical examination, vital signs, ECG, blood sampling for clinical chemistry and haematology, urinanalysis and drug screen. |
|
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 | Information not present in EudraCT |
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 | Yes |
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 |
For clarification: last 6 months are open label |
|
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 |
|
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
|
Last patient visit is foreseen for 29/10/2006 |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |