Pilot Study for the NorCAPITAL Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Plasma concentration level (Cmax and Co) of clonidine
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 between 12 and 19 years
Exclusion Criteria
- •Another disease process or current demanding life event that might explain the fatigue
- •Another chronic disease
- •Permanent use of drugs
- •Permanently bed-ridden
- •Positive pregnancy test
- •Supine systolic blood pressure (SBP) < 85 mm Hg
- •Fall in SPB upon standing > 30 mm Hg
- •Supine HR < 50 beats/min
- •Abnormal ECG
Arms & Interventions
Clonidine
Intervention: Clonidine (Drug)
Outcomes
Primary Outcomes
Plasma concentration level (Cmax and Co) of clonidine
Time Frame: After 14 days of treatment
Secondary Outcomes
- Orthostatic cardiovascular responses (head-up tilt test)(After 14 days of treatment)
- Reports of adverse effects(Participants will be followed for the duration of treatment period, an expected average of 14 days)
- Plasma concentration (Cmax) of clonidine(First day of treatment, approximately 5 hours after the first dose)
Investigators
Vegard Bruun Wyller
Associate Professor
Oslo University Hospital