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Completed

NCT Number: NCT01507701

Pilot Study for the NorCAPITAL Trial

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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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital Rikshospitalet, Dept. of Pediatrics

Oslo, NO-4950, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonidine

Drug

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

Primary outcomes

  1. Plasma concentration level (Cmax and Co) of clonidine

    Time frame: After 14 days of treatment

Secondary outcomes

  1. Orthostatic cardiovascular responses (head-up tilt test)

    Time frame: After 14 days of treatment

  2. Reports of adverse effects

    Time frame: Participants will be followed for the duration of treatment period, an expected average of 14 days

  3. Plasma concentration (Cmax) of clonidine

    Time frame: First day of treatment, approximately 5 hours after the first dose

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Jan 11, 2012
Registry last updated
Jan 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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