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Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial.


ABSTRACT: BACKGROUND: This pilot study (ClinicalTrials.gov ID: NCT01507701) assessed the feasibility and safety of clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, we assessed clonidine dosage in relation to a) plasma concentration levels, b) orthostatic cardiovascular responses, and c) possible adverse effects. FINDINGS: Five adolescent CFS patients (14-19 years old) received 50 ?g clonidine twice per day during 14 days in an open, uncontrolled design. Plasma concentration of clonidine was assayed by standard laboratory methods. Changes in orthostatic cardiovascular responses were assessed by a 20o head-up tilt-test (HUT). Adverse effects were mapped by a questionnaire.After 14 days, C0 median (range) of clonidine was 0.21 (0.18-0.36) ?g/L, and Cmax median (range) of clonidine was 0.41 (0.38-0.56) ?g/L. Also, supine blood pressures and heart rate were lower during clonidine treatment, and the HUT response was closer to the normal response. No serious adverse effects were registered. CONCLUSION: Clonidine 50 ?g BID seems to be safe enough to proceed from a pilot study to a controlled trial in a select group of adolescents with CFS (ClinicalTrials.gov ID: NCT01040429).

SUBMITTER: Fagermoen E 

PROVIDER: S-EPMC3461473 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial.

Fagermoen Even E   Sulheim Dag D   Winger Anette A   Andersen Anders M AM   Vethe Nils Tore NT   Saul J Philip JP   Thaulow Erik E   Wyller Vegard Bruun VB  

BMC research notes 20120807


<h4>Background</h4>This pilot study (ClinicalTrials.gov ID: NCT01507701) assessed the feasibility and safety of clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, we assessed clonidine dosage in relation to a) plasma concentration levels, b) orthostatic cardiovascular responses, and c) possible adverse effects.<h4>Findings</h4>Five adolescent CFS patients (14-19 years old) received 50 μg clonidine twice per day during 14 days in an open, uncontrolled design. Plasma concentrati  ...[more]

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