Pilot Study for the NorCAPITAL Trial

Not Applicable

Completed

• Conditions: Chronic Fatigue Syndrome
• Interventions: Drug: Clonidine

• Registration Number: NCT01507701
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-03
• Study First Submitted: 2011-12-22
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Last Update Submitted: 2012-01-12
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clonidine	Clonidine	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration level (Cmax and Co) of clonidine	After 14 days of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oslo University Hospital Rikshospitalet, Dept. of Pediatrics; 🇳🇴 Oslo, Norway