Elderly outpatients with primary insomnia, diagnosed according to DSM IV -TR
Conditions
Interventions
Product Name: Gaboxadol monohydrate
Product Code: Lu 02-030-X
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: gaboxadol
CAS Number: 64603-91-4
Current Sponsor code: Lu 02-030-X
Concentration n
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: NA;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. | — |
Countries
Belgium
Outcome results
None listed