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Pilot Study for the NorCAPITAL Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vegard Bruun Wyller, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01507701
First received: December 22, 2011
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  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: Open Label
Official Title: Pilot Study for the NorCAPITAL Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

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

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

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

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
NorCAPITAL study site  This link exits the ClinicalTrials.gov site

No publications provided by Oslo University Hospital

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: NCT01507701     History of Changes
Other Study ID Numbers: NorCAPITALps
Study First Received: December 22, 2011
Last Updated: January 12, 2012
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by 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
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013