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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01040429
First Posted: December 29, 2009
Last Update Posted: November 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vegard Bruun Wyller, Oslo University Hospital
  Purpose

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.

Condition Intervention Phase
Chronic Fatigue Syndrome Myalgic Encephalomyelitis Drug: Clonidine Drug: Lactose capsula Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial

Resource links provided by NLM:


Further study details as provided by Vegard Bruun Wyller, Oslo University Hospital:

Primary Outcome Measures:
  • Mean steps/day count during one week [ Time Frame: 8 weeks after inclusion ]

Secondary Outcome Measures:
  • Fatigue scores [ Time Frame: 8 and 30 weeks after inclusion ]
  • Pain scores [ Time Frame: 8 and 30 weeks after inclusion ]
  • Algometer testing response [ Time Frame: 8 and 30 weeks after inclusion ]
  • Autonomic symptom scores [ Time Frame: 8 and 30 weeks after inclusion ]
  • Quality of life-score [ Time Frame: 8 and 30 weeks after inclusion ]
  • Disability scores [ Time Frame: 8 and 30 weeks after inclusion ]
  • School attendance [ Time Frame: 8 and 30 weeks after inclusion ]
  • Mean steps/day count during one week [ Time Frame: 30 weeks after inclusion ]
  • Scores on cognitive function tests [ Time Frame: 8 and 30 weeks after inclusion ]
  • The change in mean arterial pressure (MAP) during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
  • The change in heart rate during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
  • The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test [ Time Frame: 8 and 30 weeks after inclusion ]
  • Hormonal levels (inluding tryptophan metabolites) [ Time Frame: 8 and 30 weeks after inclusion ]
  • Microbiological analyses [ Time Frame: 8 and 30 weeks after inclusion ]

Enrollment: 120
Study Start Date: February 2010
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clonidine capsula Drug: Clonidine

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.

Placebo Comparator: Lactose capsula Drug: Lactose capsula

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


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040429


Locations
Norway
Dept. of Pediatrics, Oslo University Hospital Rikshospitalet
Oslo, Norway, PO box 4950 Nydalen, 0424 Oslo
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Vegard Bruun Wyller, MD, PhD Dept. of Pediatrics, Oslo University Hospital, Norway
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Nguyen CB, Alsøe L, Lindvall JM, Sulheim D, Fagermoen E, Winger A, Kaarbø 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.
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. Erratum in: J Transl Med. 2017 Jul 18;15(1):157.
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.
Winger A, Kvarstein G, Wyller VB, Sulheim D, Fagermoen E, Småstuen 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.
Sulheim D, Fagermoen E, Winger A, Andersen AM, Godang K, Müller F, Rowe PC, Saul JP, Skovlund E, Øie 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.
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.

Responsible Party: Vegard Bruun Wyller, Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01040429     History of Changes
Other Study ID Numbers: NorCAPITAL.02
First Submitted: December 28, 2009
First Posted: December 29, 2009
Last Update Posted: November 20, 2012
Last Verified: November 2012

Keywords provided by Vegard Bruun Wyller, Oslo University Hospital:
Adolescent
Clonidine
Autonomic nervous system
Stress

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Encephalomyelitis
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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