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History of Changes for Study: NCT01040429
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial (NorCAPITAL)
Latest version (submitted November 19, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 28, 2009 None (earliest Version on record)
2 March 1, 2010 Recruitment Status, Arms and Interventions, Study Status and Contacts/Locations
3 July 18, 2011 Study Status and Outcome Measures
4 December 14, 2011 Sponsor/Collaborators and Study Status
5 June 4, 2012 Recruitment Status, Study Status and Contacts/Locations
6 November 19, 2012 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT01040429
Submitted Date:  December 28, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: NorCAPITAL.02
Brief Title: The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial (NorCAPITAL)
Official Title: The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2009
Overall Status: Not yet recruiting
Study Start: February 2010
Primary Completion: December 2010 [Anticipated]
Study Completion: August 2011 [Anticipated]
First Submitted: December 28, 2009
First Submitted that
Met QC Criteria:
December 28, 2009
First Posted: December 29, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 28, 2009
Last Update Posted: December 29, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Oslo University Hospital
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Keywords: Adolescent
Clonidine
Autonomic nervous system
Stress
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Clonidine capsula Drug: Clonidine

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

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

Placebo Comparator: Lactose capsula Drug: Clonidine

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

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

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Mean steps/day count during one week
[ Time Frame: 8 weeks after inclusion ]

Secondary Outcome Measures:
1. Fatigue scores
[ Time Frame: 8 and 30 weeks after inclusion ]

2. Pain scores
[ Time Frame: 8 and 30 weeks after inclusion ]

3. Algometer testing response
[ Time Frame: 8 and 30 weeks after inclusion ]

4. Autonomic symptom scores
[ Time Frame: 8 and 30 weeks after inclusion ]

5. Quality of life-score
[ Time Frame: 8 and 30 weeks after inclusion ]

6. Disability scores
[ Time Frame: 8 and 30 weeks after inclusion ]

7. School attendance
[ Time Frame: 8 and 30 weeks after inclusion ]

8. Mean steps/day count during one week
[ Time Frame: 30 weeks after inclusion ]

9. Scores on cognitive function tests
[ Time Frame: 8 and 30 weeks after inclusion ]

10. The change in mean arterial pressure (MAP) during head-up tilt-test
[ Time Frame: 8 and 30 weeks after inclusion ]

11. The change in heart rate during head-up tilt-test
[ Time Frame: 8 and 30 weeks after inclusion ]

12. The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test
[ Time Frame: 8 and 30 weeks after inclusion ]

13. Hormonal levels
[ Time Frame: 8 and 30 weeks after inclusion ]

14. Microbiological analyses
[ Time Frame: 8 and 30 weeks after inclusion ]

Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age: 18 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Vegard Bruun Wyller, MD, PhD
Telephone: +4723070000
Email: vegard.bruun.wyller@rikshospitalet.no
Study Officials: Vegard Bruun Wyller, MD, PhD
Principal Investigator
Dept. of Pediatrics, Oslo University Hospital, Norway
Locations: Norway
Dept. of Pediatrics, Oslo University Hospital
Oslo, Norway, NO-0027
Contact:Contact: Vegard Bruun Wyller, MD, PhD +4723070000 vegard.bruun.wyller@rikshospitalet.no
Contact:Principal Investigator: Vegard Bruun Wyller, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. Epub 2007 Feb 16. PubMed 17398200
Links:
Available IPD/Information:

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