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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


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


Minimum age: 12 Years. Maximum age: 19 Years. Gender(s): Both.


Inclusion Criteria:

- Persisting or constantly relapsing fatigue lasting 3 months or more

- Functional disability resulting from fatigue to a degree that prevent normal school


- Age between 12 and 19 years

Exclusion Criteria:

- Another disease process or current demanding life event that might explain the


- 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

Page last updated: August 20, 2015

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