Pilot Study for the NorCAPITAL Trial

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01507701

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome	Drug: Clonidine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Pilot Study for the NorCAPITAL Trial

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clonidine	Drug: Clonidine 50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.

Arm

Intervention/Treatment

Experimental: Clonidine

Drug: Clonidine

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

Outcome Measures

Primary Outcome Measures

Plasma concentration level (Cmax and Co) of clonidine [After 14 days of treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital Rikshospitalet, Dept. of Pediatrics	Oslo		Norway	NO-4950

Sponsors and Collaborators

Oslo University Hospital

Investigators

Principal Investigator: Vegard Bruun Wyller, MD, PhD, Oslo University Hospital Rikshospitalet, Dept. of Pediatrics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vegard Bruun Wyller, Associate Professor, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01507701

Other Study ID Numbers:

NorCAPITALps

First Posted:

Jan 11, 2012

Last Update Posted:

Jan 13, 2012

Last Verified:

Jan 1, 2012

Keywords provided by Vegard Bruun Wyller, Associate Professor, Oslo University Hospital

adolescents

Additional relevant MeSH terms:

Fatigue Syndrome, Chronic

Clonidine

Study Results

No Results Posted as of Jan 13, 2012