Pilot Study for the NorCAPITAL Trial
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Fatigue Syndrome
Intervention: Clonidine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Oslo University Hospital Official(s) and/or principal investigator(s):
Vegard Bruun Wyller, MD, PhD, Principal Investigator, Affiliation: Oslo University Hospital Rikshospitalet, Dept. of Pediatrics
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.
Clinical Details
Official title: Pilot Study for the NorCAPITAL Trial
Study design: Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Plasma concentration level (Cmax and Co) of clonidine
Secondary outcome: Orthostatic cardiovascular responses (head-up tilt test)Reports of adverse effects Plasma concentration (Cmax) of clonidine
Eligibility
Minimum age: 12 Years.
Maximum age: 19 Years.
Gender(s): Both.
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 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
Locations and Contacts
Oslo University Hospital Rikshospitalet, Dept. of Pediatrics, Oslo NO-4950, Norway
Additional Information
NorCAPITAL study site
Starting date: January 2010
Last updated: January 12, 2012
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