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

Chronic Fatigue Syndrome Clinical Trial

— NorCAPITAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040429
• Other study ID #: NorCAPITAL.02
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2009
• Last updated: November 19, 2012
• Start date: February 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical 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 adolescent CFS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Myalgic Encephalomyelitis
• Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
Norway	Dept. of Pediatrics, Oslo University Hospital Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean steps/day count during one week		8 weeks after inclusion	No
Secondary	Fatigue scores		8 and 30 weeks after inclusion	No
Secondary	Pain scores		8 and 30 weeks after inclusion	No
Secondary	Algometer testing response		8 and 30 weeks after inclusion	No
Secondary	Autonomic symptom scores		8 and 30 weeks after inclusion	No
Secondary	Quality of life-score		8 and 30 weeks after inclusion	No
Secondary	Disability scores		8 and 30 weeks after inclusion	No
Secondary	School attendance		8 and 30 weeks after inclusion	No
Secondary	Mean steps/day count during one week		30 weeks after inclusion	No
Secondary	Scores on cognitive function tests		8 and 30 weeks after inclusion	No
Secondary	The change in mean arterial pressure (MAP) during head-up tilt-test		8 and 30 weeks after inclusion	Yes
Secondary	The change in heart rate during head-up tilt-test		8 and 30 weeks after inclusion	Yes
Secondary	The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test		8 and 30 weeks after inclusion	No
Secondary	Hormonal levels (inluding tryptophan metabolites)		8 and 30 weeks after inclusion	No
Secondary	Microbiological analyses		8 and 30 weeks after inclusion	No

External Links

•   Statistical analysis plan - NorCAPITAL intervention arm
•   Unit for Chronic Fatigue Syndrome in Adolescent, Oslo University Hospital