NCT01040429

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

2.3 years

First QC Date

December 28, 2009

Last Update Submit

November 19, 2012

Conditions

Chronic Fatigue SyndromeMyalgic Encephalomyelitis

Keywords

AdolescentClonidineAutonomic nervous systemStress

Outcome Measures

Primary Outcomes (1)

  • Mean steps/day count during one week

    8 weeks after inclusion

Secondary Outcomes (14)

  • Fatigue scores

    8 and 30 weeks after inclusion

  • Pain scores

    8 and 30 weeks after inclusion

  • Algometer testing response

    8 and 30 weeks after inclusion

  • Autonomic symptom scores

    8 and 30 weeks after inclusion

  • Quality of life-score

    8 and 30 weeks after inclusion

  • +9 more secondary outcomes

Study Arms (2)

Clonidine capsula

ACTIVE COMPARATOR
Drug: Clonidine

Lactose capsula

PLACEBO COMPARATOR
Drug: Lactose capsula

Interventions

ClonidineDRUG

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.

Clonidine capsula
Lactose capsulaDRUG

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

Lactose capsula

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Persisting or constantly relapsing fatigue lasting 3 months or more.
  • Functional disability resulting from fatigue to a degree that prevent normal school attendance

You may not qualify if:

  • 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
  • Supine heart rate \< 50 beats/min
  • Supine systolic blood pressure \< 85 mmHg
  • Systolic blood pressure fall upon standing \> 30 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Pediatrics, Oslo University Hospital Rikshospitalet

Oslo, Oslo County, PO box 4950 Nydalen, 0424 Oslo, Norway

Location

Related Publications (10)

  • Wyller VB, Eriksen HR, Malterud K. Can sustained arousal explain the Chronic Fatigue Syndrome? Behav Brain Funct. 2009 Feb 23;5:10. doi: 10.1186/1744-9081-5-10.

    PMID: 19236717BACKGROUND

  • Wyller VB, Due R, Saul JP, Amlie JP, Thaulow E. Usefulness of an abnormal cardiovascular response during low-grade head-up tilt-test for discriminating adolescents with chronic fatigue from healthy controls. Am J Cardiol. 2007 Apr 1;99(7):997-1001. doi: 10.1016/j.amjcard.2006.10.067. Epub 2007 Feb 16.

    PMID: 17398200BACKGROUND

  • Asprusten TT, Sletner L, Wyller VBB. Are there subgroups of chronic fatigue syndrome? An exploratory cluster analysis of biological markers. J Transl Med. 2021 Jan 30;19(1):48. doi: 10.1186/s12967-021-02713-9.

    PMID: 33516248DERIVED

  • Wyller VB, Nguyen CB, Ludviksen JA, Mollnes TE. Transforming growth factor beta (TGF-beta) in adolescent chronic fatigue syndrome. J Transl Med. 2017 Dec 4;15(1):245. doi: 10.1186/s12967-017-1350-1.

    PMID: 29202780DERIVED

  • Nguyen CB, Alsoe L, Lindvall JM, Sulheim D, Fagermoen E, Winger A, Kaarbo M, Nilsen H, Wyller VB. Whole blood gene expression in adolescent chronic fatigue syndrome: an exploratory cross-sectional study suggesting altered B cell differentiation and survival. J Transl Med. 2017 May 11;15(1):102. doi: 10.1186/s12967-017-1201-0.

    PMID: 28494812DERIVED

  • Wyller VB, Vitelli V, Sulheim D, Fagermoen E, Winger A, Godang K, Bollerslev J. Altered neuroendocrine control and association to clinical symptoms in adolescent chronic fatigue syndrome: a cross-sectional study. J Transl Med. 2016 May 5;14(1):121. doi: 10.1186/s12967-016-0873-1.

    PMID: 27149955DERIVED

  • Fagermoen E, Sulheim D, Winger A, Andersen AM, Gjerstad J, Godang K, Rowe PC, Saul JP, Skovlund E, Wyller VB. Effects of low-dose clonidine on cardiovascular and autonomic variables in adolescents with chronic fatigue: a randomized controlled trial. BMC Pediatr. 2015 Sep 10;15:117. doi: 10.1186/s12887-015-0428-2.

    PMID: 26357864DERIVED

  • Winger A, Kvarstein G, Wyller VB, Sulheim D, Fagermoen E, Smastuen MC, Helseth S. Pain and pressure pain thresholds in adolescents with chronic fatigue syndrome and healthy controls: a cross-sectional study. BMJ Open. 2014 Oct 6;4(9):e005920. doi: 10.1136/bmjopen-2014-005920.

    PMID: 25287104DERIVED

  • Sulheim D, Fagermoen E, Winger A, Andersen AM, Godang K, Muller F, Rowe PC, Saul JP, Skovlund E, Oie MG, Wyller VB. Disease mechanisms and clonidine treatment in adolescent chronic fatigue syndrome: a combined cross-sectional and randomized clinical trial. JAMA Pediatr. 2014 Apr;168(4):351-60. doi: 10.1001/jamapediatrics.2013.4647.

    PMID: 24493300DERIVED

  • 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.

    PMID: 22871021DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Vegard Bruun Wyller, MD, PhD

    Dept. of Pediatrics, Oslo University Hospital, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 29, 2009

Study Start

February 1, 2010

Primary Completion

June 1, 2012

Study Completion

November 1, 2012

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

NO(1)