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Pilot Study for the NorCAPITAL Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507701
First Posted: January 11, 2012
Last Update Posted: January 13, 2012
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.
Information provided by (Responsible Party):
Vegard Bruun Wyller, Oslo University Hospital
  Purpose

The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure responses when rising up), and c) reports of possible adverse effects.

A possible beneficial effect of clonidine in adolescent CFS will be investigated in NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.


Condition Intervention
Chronic Fatigue Syndrome Drug: Clonidine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot Study for the NorCAPITAL Trial

Resource links provided by NLM:


Further study details as provided by Vegard Bruun Wyller, Oslo University Hospital:

Primary Outcome Measures:
  • Plasma concentration level (Cmax and Co) of clonidine [ Time Frame: After 14 days of treatment ]

Secondary Outcome Measures:
  • Orthostatic cardiovascular responses (head-up tilt test) [ Time Frame: After 14 days of treatment ]
  • Reports of adverse effects [ Time Frame: Participants will be followed for the duration of treatment period, an expected average of 14 days ]
  • Plasma concentration (Cmax) of clonidine [ Time Frame: First day of treatment, approximately 5 hours after the first dose ]

Enrollment: 5
Study Start Date: January 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clonidine Drug: Clonidine
50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Age between 12 and 19 years

Exclusion Criteria:

  • Another disease process or current demanding life event that might explain the fatigue
  • Another chronic disease
  • Permanent use of drugs
  • Permanently bed-ridden
  • Positive pregnancy test
  • Supine systolic blood pressure (SBP) < 85 mm Hg
  • Fall in SPB upon standing > 30 mm Hg
  • Supine HR < 50 beats/min
  • Abnormal ECG
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507701


Locations
Norway
Oslo University Hospital Rikshospitalet, Dept. of Pediatrics
Oslo, Norway, NO-4950
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Vegard Bruun Wyller, MD, PhD Oslo University Hospital Rikshospitalet, Dept. of Pediatrics
  More Information

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: NCT01507701     History of Changes
Other Study ID Numbers: NorCAPITALps
First Submitted: December 22, 2011
First Posted: January 11, 2012
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Vegard Bruun Wyller, Oslo University Hospital:
adolescents

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