Pilot Study for the NorCAPITAL Trial

Chronic Fatigue Syndrome Clinical Trial

Official title:

Pilot Study for the NorCAPITAL Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507701
• Other study ID #: NorCAPITALps
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: January 12, 2012
• Start date: January 2010

Study information

• Verified date: January 2012
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 19 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue Syndrome, Chronic

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital Rikshospitalet, Dept. of Pediatrics	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration level (Cmax and Co) of clonidine		After 14 days of treatment	Yes
Secondary	Orthostatic cardiovascular responses (head-up tilt test)		After 14 days of treatment	Yes
Secondary	Reports of adverse effects		Participants will be followed for the duration of treatment period, an expected average of 14 days	Yes
Secondary	Plasma concentration (Cmax) of clonidine		First day of treatment, approximately 5 hours after the first dose	Yes

External Links

•   NorCAPITAL study site