NCT00833209

Brief Summary

Medication Overuse Headache (MOH) is an illness affecting about 1,5 % of the general population. It is characterized by chronic headache occurring for at least 15 days a month, by a use of antimigraine drugs during at least 3 months for more than 10 days a month (for ergots, triptans, opiate derivates and combined analgesics) or for more than 15 days a month (for simple analgesics). The chronic headache must have occurred during the period of antimigraine drug abuse and the headache must have returned to its episodical pattern after withdrawal of antimigraine drugs. But, about 50% of the MOH patients will relapse during the first year following the antimigraine drugs withdrawal. The pathophysiology of MOH is still largely unknown, and the role of antimigraine drug abuse in the transformation from migraine through MOH is not fully understood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

2.4 years

First QC Date

January 29, 2009

Last Update Submit

July 31, 2012

Conditions

Medication Overuse Headache

Keywords

Orbitofrontal cortexMedication Overuse HeadacheChronic headachewithdrawal

Outcome Measures

Primary Outcomes (1)

  • basal cerebral metabolism using (18F)FDG-PET

    before withdrawal, 3 months, 1 year

Secondary Outcomes (2)

  • Relapse

    All study long

  • Magnetic Resonance Imaging data

    before withdrawal and at one year

Study Arms (3)

1

EXPERIMENTAL

Patients with Medication Overuse Headache (MOH)

Procedure: PET (withdrawal)

2

SHAM COMPARATOR

controls suffering from migraine

Procedure: Imaging

3

SHAM COMPARATOR

controls without any neurological disease

Procedure: Imaging

Interventions

PET (withdrawal)PROCEDURE

3 (18F)FDG-PET (before withdrawal, 3 months, 1 year), 2 MRI (before withdrawal, 1 year), will take the Iowa Gambling Task Test(before withdrawal) and will answer questionnaires measuring psychological dimensions (before withdrawal, 3 months, 1 year)

1
ImagingPROCEDURE

2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than eighteen years
  • suffering from MOH (ICHD-II criteria)
  • French speaking
  • who wish to go on a withdrawal procedure

You may not qualify if:

  • pregnant women or women of child bearing age who are not using contraception
  • post traumatic headaches
  • illnesses interfering with the central nervous system functionning
  • psychotic disorder or current major depressive episode
  • contraindication for PET or MRI (Magnetic Resonnance Imaging)
  • contraindication for all prophylactic treatment for migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire

Bordeaux, 33076, France

Location

CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur

Bordeaux, 33076, France

Location

Related Publications (1)

  • Meyer M, Di Scala G, Edde M, Dilharreguy B, Radat F, Allard M, Chanraud S. Brain structural investigation and hippocampal tractography in medication overuse headache: a native space analysis. Behav Brain Funct. 2017 Apr 8;13(1):6. doi: 10.1186/s12993-017-0124-5.

    PMID: 28390437DERIVED

MeSH Terms

Conditions

Headache Disorders, SecondaryHeadache Disorders

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleX-Rays

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Françoise RADAT, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2011

Study Completion

May 1, 2012

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

FR(2)