ClinicalTrials.Veeva

Menu

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

University of Oslo (UIO) logo

University of Oslo (UIO)

Status and phase

Completed
Phase 2

Conditions

Myalgic Encephalomyelitis
Chronic Fatigue Syndrome

Treatments

Drug: Clonidine
Drug: Lactose capsula

Study type

Interventional

Funder types

Other

Identifiers

NCT01040429
NorCAPITAL.02

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

12 to 18 years old

Volunteers

Accepts 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

Exclusion criteria

  • Another disease process or current demanding life event that might explain the fatigue
  • Another chronic disease (in particular pheochromocytoma, polyneuropathy, Renal insufficiency)
  • Permanent use of pharmaceuticals (including hormone drugs)
  • Permanently bed-ridden
  • Positive pregnancy test
  • Evidence of reduced cerebral and/or peripheral circulation due to vessel disease
  • Know hypersensitivity towards clonidine or inert substances (lactose, sakkarose) in capsula
  • Abnormal ECG (in particular bradyarrythmias due to sick sinus syndrome or AV-block. Isolated ectopic beats do not lead to exclusion)
  • Supine heart rate < 50 beats/min
  • Supine systolic blood pressure < 85 mmHg
  • Systolic blood pressure fall upon standing > 30 mmHg

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups, including a placebo group

Clonidine capsula
Active Comparator group
Treatment:
Drug: Clonidine
Lactose capsula
Placebo Comparator group
Treatment:
Drug: Lactose capsula

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems