Chronic fatigue syndrom/myalgic encephalomyelitis (CFS/ME) in adolescents
Conditions
Interventions
Trade Name: Catapresan
Product Name: Catapresan
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Division of Paediatrics, Rikshospitalet University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Persisting or constantly relapsing fatigue lasting 3 months or more. - Functional disability resulting from fatigue to a degree that prevent normal school attendance - Age = 12 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Another disease process or current demanding life event that might explain the fatigue - Another chronic disease - Permanent use of pharmaceuticals (including hormone drugs) - Permanently bed-ridden - Positive pregnancy test - Supine heart rate 30 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Whether treatment with clonidine improves symptom scores, school attendance, quality of life, autonomic responses and endocrine responses (secondary end points) as compared to placebo in adolescents with CFS/ME - Whether treatment with clonidine improves cognitive functions (executive control functions and emotional memory in particular) and alters functional neuroradiological findings as compared to placebo in adolescents with CFS/ME - Whether eventual differences among the treatment group and the placebo group persist after discontinuation of the drug;Primary end point(s): Mean steps/day count during one week 8 weeks after inclusion;Main Objective: Whether treatment with clonidine increase activity level as compared to placebo in adolescents with CFS/ME | — |
Countries
Norway
Outcome results
None listed