Pilot Study for the NorCAPITAL Trial
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|ClinicalTrials.gov Identifier: NCT01507701|
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome||Drug: Clonidine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study for the NorCAPITAL Trial|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||March 2010|
50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.
- Plasma concentration level (Cmax and Co) of clonidine [ Time Frame: After 14 days of treatment ]
- Orthostatic cardiovascular responses (head-up tilt test) [ Time Frame: After 14 days of treatment ]
- Reports of adverse effects [ Time Frame: Participants will be followed for the duration of treatment period, an expected average of 14 days ]
- Plasma concentration (Cmax) of clonidine [ Time Frame: First day of treatment, approximately 5 hours after the first dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507701
|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|