Pilot Study for the NorCAPITAL Trial
The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure responses when rising up), and c) reports of possible adverse effects.
A possible beneficial effect of clonidine in adolescent CFS will be investigated in NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Pilot Study for the NorCAPITAL Trial|
- Plasma concentration level (Cmax and Co) of clonidine [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: Yes ]
- Orthostatic cardiovascular responses (head-up tilt test) [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: Yes ]
- Reports of adverse effects [ Time Frame: Participants will be followed for the duration of treatment period, an expected average of 14 days ] [ Designated as safety issue: Yes ]
- Plasma concentration (Cmax) of clonidine [ Time Frame: First day of treatment, approximately 5 hours after the first dose ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.
|Oslo University Hospital Rikshospitalet, Dept. of Pediatrics|
|Oslo, Norway, NO-4950|
|Principal Investigator:||Vegard Bruun Wyller, MD, PhD||Oslo University Hospital Rikshospitalet, Dept. of Pediatrics|