Pilot Study for the NorCAPITAL Trial

January 12, 2012 updated by: Vegard Bruun Wyller, Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, NO-4950
        • Oslo University Hospital Rikshospitalet, Dept. of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration level (Cmax and Co) of clonidine
Time Frame: After 14 days of treatment
After 14 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Orthostatic cardiovascular responses (head-up tilt test)
Time Frame: After 14 days of treatment
After 14 days of treatment
Reports of adverse effects
Time Frame: Participants will be followed for the duration of treatment period, an expected average of 14 days
Participants will be followed for the duration of treatment period, an expected average of 14 days
Plasma concentration (Cmax) of clonidine
Time Frame: First day of treatment, approximately 5 hours after the first dose
First day of treatment, approximately 5 hours after the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 12, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorCAPITALps

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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