ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01040429
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
Vegard Bruun Wyller, Oslo University Hospital

December 28, 2009
December 29, 2009
November 20, 2012
February 2010
June 2012   (Final data collection date for primary outcome measure)
Mean steps/day count during one week [ Time Frame: 8 weeks after inclusion ]
Same as current
Complete list of historical versions of study NCT01040429 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 [ Time Frame: 8 and 30 weeks after inclusion ]
  • Microbiological analyses [ Time Frame: 8 and 30 weeks after inclusion ]
Not Provided
Not Provided
 
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis
  • 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.

  • 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

  • Active Comparator: Clonidine capsula
    Intervention: Drug: Clonidine
  • Placebo Comparator: Lactose capsula
    Intervention: Drug: Lactose capsula

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Same as current
November 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01040429
NorCAPITAL.02
Yes
Not Provided
Not Provided
Vegard Bruun Wyller, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Vegard Bruun Wyller, MD, PhD Dept. of Pediatrics, Oslo University Hospital, Norway
Oslo University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP