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Chronic Fatigue SyndromePhase 2NorCAPITALNCT01040429

The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial

A Phase 2 study testing Clonidine and Lactose capsula in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study IS to explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents, particularly focusing on genetics, infections/immunology, endocrinology, autonomic control and cognitions to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity) in… Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
What is being tested?
Clonidine and Lactose capsula
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteNorway
Study dates
Feb 2010to Nov 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Persisting or constantly relapsing fatigue lasting 3 months or more.
  • Functional disability resulting from fatigue to a degree that prevent normal school attendance

Who cannot join

  • Another disease process or current demanding life event that might explain the fatigue
  • Another chronic disease (in particular pheochromocytoma, polyneuropathy, Renal insufficiency)
  • Permanent use of pharmaceuticals (including hormone drugs)
  • Permanently bed-ridden
  • Positive pregnancy test
  • Evidence of reduced cerebral and/or peripheral circulation due to vessel disease
Show all 11Show fewer
  • Know hypersensitivity towards clonidine or inert substances (lactose, sakkarose) in capsula
  • Abnormal ECG (in particular bradyarrythmias due to sick sinus syndrome or AV-block. Isolated ectopic beats do not lead to exclusion)
  • Supine heart rate < 50 beats/min
  • Supine systolic blood pressure < 85 mmHg
  • Systolic blood pressure fall upon standing > 30 mmHg

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Dept. of Pediatrics, Oslo University Hospital Rikshospitalet

    Oslo, Oslo, PO box 4950 Nydalen, 0424 Oslo

Other trials in Norway

About this study

The purpose of this study IS to

  • explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents, particularly focusing on genetics, infections/immunology, endocrinology, autonomic control and cognitions
  • to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity) in adolescent CFS.
Being tested
Clonidine, Lactose capsula
Keywords
Adolescent, Clonidine, Autonomic nervous system, Stress
Medical subject headings
Fatigue Syndrome, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClonidineDrug

    Day 1-56 (week 1-8): 25 microgram (1 capsula) x 2/day for patients < 35 kg; 50 microgram (2 capsula) x 2/day for patients > 35 kg.

    Day 57-63 (week 9): 25 microgram (1 capsula) x 1/day for patients < 35 kg; 25 microgram (2 capsula) x 2/day for patients > 35 kg.

  • Lactose capsulaDrug

    Day 1-56 (week 1-8): 1 capsula x 2/day for patients < 35 kg; 2 capsula x 2/day for patients > 35 kg.

    Day 57-63 (week 9): 1 capsula x 1/day for patients < 35 kg; 1 capsula x 2/day for patients > 35 kg

Study groups in NCT01040429
Study groupRoleWhat they receive
Clonidine capsulaActive comparatorNot described
Receives: Drug: Clonidine
Lactose capsulaPlacebo comparatorNot described
Receives: Drug: Lactose capsula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean steps/day count during one week

    Measured: 8 weeks after inclusion

Secondary outcomes (14)

  1. Fatigue scores

    Measured: 8 and 30 weeks after inclusion

  2. Pain scores

    Measured: 8 and 30 weeks after inclusion

  3. Algometer testing response

    Measured: 8 and 30 weeks after inclusion

  4. Autonomic symptom scores

    Measured: 8 and 30 weeks after inclusion

  5. Quality of life-score

    Measured: 8 and 30 weeks after inclusion

  6. Disability scores

    Measured: 8 and 30 weeks after inclusion

  7. School attendance

    Measured: 8 and 30 weeks after inclusion

  8. Mean steps/day count during one week

    Measured: 30 weeks after inclusion

  9. Scores on cognitive function tests

    Measured: 8 and 30 weeks after inclusion

  10. The change in mean arterial pressure (MAP) during head-up tilt-test

    Measured: 8 and 30 weeks after inclusion

  11. The change in heart rate during head-up tilt-test

    Measured: 8 and 30 weeks after inclusion

  12. The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test

    Measured: 8 and 30 weeks after inclusion

  13. Hormonal levels (inluding tryptophan metabolites)

    Measured: 8 and 30 weeks after inclusion

  14. Microbiological analyses

    Measured: 8 and 30 weeks after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionJun 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01040429
Sponsor's protocol ID
NorCAPITAL.02
Acronym
NorCAPITAL
Status last verified
Nov 2012
First submitted
28 Dec 2009
Last updated
20 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Wyller VB, Eriksen HR, Malterud K. Can sustained arousal explain the Chronic Fatigue Syndrome? Behav Brain Funct. 2009 Feb 23;5:10. doi: 10.1186/1744-9081-5-10.

    PubMed 19236717

  • Wyller VB, Due R, Saul JP, Amlie JP, Thaulow E. Usefulness of an abnormal cardiovascular response during low-grade head-up tilt-test for discriminating adolescents with chronic fatigue from healthy controls. Am J Cardiol. 2007 Apr 1;99(7):997-1001. doi: 10.1016/j.amjcard.2006.10.067. Epub 2007 Feb 16.

    PubMed 17398200

  • Asprusten TT, Sletner L, Wyller VBB. Are there subgroups of chronic fatigue syndrome? An exploratory cluster analysis of biological markers. J Transl Med. 2021 Jan 30;19(1):48. doi: 10.1186/s12967-021-02713-9.

    PubMed 33516248

  • Wyller VB, Nguyen CB, Ludviksen JA, Mollnes TE. Transforming growth factor beta (TGF-beta) in adolescent chronic fatigue syndrome. J Transl Med. 2017 Dec 4;15(1):245. doi: 10.1186/s12967-017-1350-1.

    PubMed 29202780

  • Nguyen CB, Alsoe L, Lindvall JM, Sulheim D, Fagermoen E, Winger A, Kaarbo M, Nilsen H, Wyller VB. Whole blood gene expression in adolescent chronic fatigue syndrome: an exploratory cross-sectional study suggesting altered B cell differentiation and survival. J Transl Med. 2017 May 11;15(1):102. doi: 10.1186/s12967-017-1201-0.

    PubMed 28494812

  • Wyller VB, Vitelli V, Sulheim D, Fagermoen E, Winger A, Godang K, Bollerslev J. Altered neuroendocrine control and association to clinical symptoms in adolescent chronic fatigue syndrome: a cross-sectional study. J Transl Med. 2016 May 5;14(1):121. doi: 10.1186/s12967-016-0873-1.

    PubMed 27149955

  • Fagermoen E, Sulheim D, Winger A, Andersen AM, Gjerstad J, Godang K, Rowe PC, Saul JP, Skovlund E, Wyller VB. Effects of low-dose clonidine on cardiovascular and autonomic variables in adolescents with chronic fatigue: a randomized controlled trial. BMC Pediatr. 2015 Sep 10;15:117. doi: 10.1186/s12887-015-0428-2.

    PubMed 26357864

  • Winger A, Kvarstein G, Wyller VB, Sulheim D, Fagermoen E, Smastuen MC, Helseth S. Pain and pressure pain thresholds in adolescents with chronic fatigue syndrome and healthy controls: a cross-sectional study. BMJ Open. 2014 Oct 6;4(9):e005920. doi: 10.1136/bmjopen-2014-005920.

    PubMed 25287104

  • Sulheim D, Fagermoen E, Winger A, Andersen AM, Godang K, Muller F, Rowe PC, Saul JP, Skovlund E, Oie MG, Wyller VB. Disease mechanisms and clonidine treatment in adolescent chronic fatigue syndrome: a combined cross-sectional and randomized clinical trial. JAMA Pediatr. 2014 Apr;168(4):351-60. doi: 10.1001/jamapediatrics.2013.4647.

    PubMed 24493300

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clonidine and Lactose capsula in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean steps/day count during one week (time frame: 8 weeks after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01040429, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.

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