Pilot Study for the NorCAPITAL Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Fatigue Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Clonidine

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.

Interventions

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Clonidine

50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No