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Pilot Study for the NorCAPITAL Trial

NCT01507701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-01-13

No results posted yet for this study

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.

Conditions

  • Chronic Fatigue Syndrome

Interventions

DRUG

Clonidine

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

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Vegard Bruun Wyller, MD, PhD · Oslo University Hospital Rikshospitalet, Dept. of Pediatrics

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-03-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507701 on ClinicalTrials.gov