Trial record 6 of 65 for:    "Chronic Fatigue Syndrome"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vegard Bruun Wyller, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01040429
First received: December 28, 2009
Last updated: November 19, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Oslo University Hospital:

Primary Outcome Measures:
  • Mean steps/day count during one week [ Time Frame: 8 weeks after inclusion ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vegard Bruun Wyller, Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01040429     History of Changes
Other Study ID Numbers: NorCAPITAL.02
Study First Received: December 28, 2009
Last Updated: November 19, 2012
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Adolescent
Clonidine
Autonomic nervous system
Stress

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

ClinicalTrials.gov processed this record on July 23, 2014