Pilot Study for the NorCAPITAL Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01507701

Enrollment

Registered

2012-01-11

Start date

2010-01-31

Completion date

Unknown

Last updated

2012-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome

Keywords

adolescents

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.

Interventions

DRUGClonidine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 19 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Plasma concentration level (Cmax and Co) of clonidine	After 14 days of treatment

Secondary

Measure	Time frame
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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026