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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10mg-
Pharmaceutica
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium
Outcome results
None listed