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The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial

NCT01040429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-11-20

No results posted yet for this study

Summary

The purpose of this study IS to

* explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents, particularly focusing on genetics, infections/immunology, endocrinology, autonomic control and cognitions
* to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity) in adolescent CFS.

Conditions

  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis

Interventions

DRUG

Clonidine

Day 1-56 (week 1-8): 25 microgram (1 capsula) x 2/day for patients \< 35 kg; 50 microgram (2 capsula) x 2/day for patients \> 35 kg. Day 57-63 (week 9): 25 microgram (1 capsula) x 1/day for patients \< 35 kg; 25 microgram (2 capsula) x 2/day for patients \> 35 kg.

DRUG

Lactose capsula

Day 1-56 (week 1-8): 1 capsula x 2/day for patients \< 35 kg; 2 capsula x 2/day for patients \> 35 kg. Day 57-63 (week 9): 1 capsula x 1/day for patients \< 35 kg; 1 capsula x 2/day for patients \> 35 kg

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Vegard Bruun Wyller, MD, PhD · Dept. of Pediatrics, Oslo University Hospital, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2012-11-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01040429 on ClinicalTrials.gov