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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

Tracking Information
First Submitted Date  ICMJE December 28, 2009
First Posted Date  ICMJE December 29, 2009
Last Update Posted Date November 20, 2012
Study Start Date  ICMJE February 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2009)
Mean steps/day count during one week [ Time Frame: 8 weeks after inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Official Title  ICMJE The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Brief 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 adolescent CFS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • Active Comparator: Clonidine capsula
    Intervention: Drug: Clonidine
  • Placebo Comparator: Lactose capsula
    Intervention: Drug: Lactose capsula
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2009)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01040429
Other Study ID Numbers  ICMJE NorCAPITAL.02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vegard Bruun Wyller, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vegard Bruun Wyller, MD, PhD Dept. of Pediatrics, Oslo University Hospital, Norway
PRS Account Oslo University Hospital
Verification Date November 2012

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