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CompletedNCT01507701Updated Jan 13, 2012

Pilot Study for the NorCAPITAL Trial

An interventional study of Clonidine in Chronic Fatigue Syndrome, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2012-01-13.

Sponsored by Oslo University Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
12 Years to 19 Years
Sex
All
01

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.

02

Conditions studied

  • Chronic Fatigue Syndrome

Keywords

  • adolescents
03

In context

Fatigue Syndrome, Chronic

246 studies on the registry are indexed under Fatigue Syndrome, Chronic; 58 are open to participants now.

This study's enrollment of 5 is below the median of 60 across 166 interventional studies indexed under Fatigue Syndrome, Chronic.

Browse Fatigue Syndrome, Chronic studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Clonidine

    Drug: Clonidine

Interventions

  • DrugClonidine

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

06

What researchers measure

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

07

Study locations

1 site
  • Oslo University Hospital Rikshospitalet, Dept. of Pediatrics
    Oslo, NO-4950, Norway
08

References and documents

Publications

  • Fagermoen E, Sulheim D, Winger A, Andersen AM, Vethe NT, Saul JP, Thaulow E, Wyller VB. Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial. BMC Res Notes. 2012 Aug 7;5:418. doi: 10.1186/1756-0500-5-418. PubMed 22871021 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01507701
Lead sponsor
Oslo University Hospital
Responsible party
Vegard Bruun Wyller (Associate Professor, Oslo University Hospital) — Principal investigator
First posted
Jan 11, 2012
Start date
Jan 2010
Primary completion
Mar 2010
Last update
Jan 13, 2012

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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