Pilot Study for the NorCAPITAL Trial

NCT01507701 | Completed DMC

• 1 other identifier: NorCAPITALps
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Keywords

adolescents

Outcome Measures

Primary Outcomes (1)

• Plasma concentration level (Cmax and Co) of clonidine

  After 14 days of treatment

Secondary Outcomes (3)

• Orthostatic cardiovascular responses (head-up tilt test)

  After 14 days of treatment

• Reports of adverse effects

  Participants will be followed for the duration of treatment period, an expected average of 14 days

• Plasma concentration (Cmax) of clonidine

  First day of treatment, approximately 5 hours after the first dose

Study Arms (1)

Clonidine

EXPERIMENTAL

Drug: Clonidine

Interventions

Clonidine DRUG

50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.

Clonidine

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital Rikshospitalet, Dept. of Pediatrics

Oslo, NO-4950, Norway

Location

Related Publications (1)

• Fagermoen E, Sulheim D, Winger A, Andersen AM, Vethe NT, Saul JP, Thaulow E, Wyller VB. Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial. BMC Res Notes. 2012 Aug 7;5:418. doi: 10.1186/1756-0500-5-418.

  PMID: 22871021 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vegard Bruun Wyller, MD, PhD

  Oslo University Hospital Rikshospitalet, Dept. of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 11, 2012
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Last Updated: January 13, 2012

Record last verified: 2012-01

Locations

NO (1)