Protocol title study No. 10402:A 12-month Phase III safety study of gaboxadol 10 mg daily consisting of a 6-month double-blind, randomised, placebo-controlled, parallel-group periodfollowed by a 6-month open-label period in elderly outpatients with primary insomnia - NA
- Conditions
- Elderly outpatients with primary insomnia, diagnosed according to DSM IV-TR
- Registration Number
- EUCTR2004-001264-45-BE
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to obtain 12 month safety data of gaboxadol 10mg in elderly patients.;Secondary Objective: In addition efficacy, withdrawal symptoms and rebound insomnia after long-term gaboxadol treatment will be evaluated.;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.
- Secondary Outcome Measures
Name Time Method