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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | 50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration level (Cmax and Co) of clonidine | After 14 days of treatment |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vegard Bruun Wyller, MD, PhD | Oslo University Hospital Rikshospitalet, Dept. of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital Rikshospitalet, Dept. of Pediatrics | Oslo | NO-4950 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22871021 | Derived | 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. |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Plasma concentration (Cmax) of clonidine | First day of treatment, approximately 5 hours after the first dose |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |