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Trial record 90 of 326 for:    clonidine

Pilot Study for the NorCAPITAL Trial

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. Identifier: NCT01507701
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 13, 2012
Information provided by (Responsible Party):
Vegard Bruun Wyller, Oslo University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Drug: Clonidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot Study for the NorCAPITAL Trial
Study Start Date : January 2010
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Clonidine Drug: Clonidine
50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.

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

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

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

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

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 identifier (NCT number): NCT01507701

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vegard Bruun Wyller, Associate Professor, Oslo University Hospital Identifier: NCT01507701     History of Changes
Other Study ID Numbers: NorCAPITALps
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012
Keywords provided by Vegard Bruun Wyller, Oslo University Hospital:
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action