Orbitofrontal Cortex (OFC) Influence on Addictive Medication Overuse Headache (MOH) Deriving From Migraine - Full Text View

Sponsor:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00833209

Purpose

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.

Condition	Intervention
Medication Overuse Headache	Procedure: PET (withdrawal) Procedure: Imaging

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

basal cerebral metabolism using (18F)FDG-PET [ Time Frame: before withdrawal, 3 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relapse [ Time Frame: All study long ] [ Designated as safety issue: No ]
Magnetic Resonance Imaging data [ Time Frame: before withdrawal and at one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Patients with Medication Overuse Headache (MOH)	Procedure: PET (withdrawal) 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)
Sham Comparator: 2 controls suffering from migraine	Procedure: Imaging 2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)
Sham Comparator: 3 controls without any neurological disease	Procedure: Imaging 1 MRI ; Iowa Gambling Task test and questionnaires.

Detailed Description:

We recently explored cerebral metabolism in these MOH patients using (18F)FDG-PET (Fluoro Dexoxy Glucose Positon Emission Tomography) comparing them with controls. Results showed a hypometabolism in the OFC, which persist immediately after the antimigraine drugs withdrawal. A similar pattern is observed in varied substance related disorders and should be a marker of addictive behaviour. It can be linked with difficulties in the decision-making process, which can be explored by the Iowa Gambling Task (IGT) test.

Several questions are still unanswered. What will this abnormality become in the long term ? Is it predictive of susceptibility for relapse? Can it be linked to a specific psychological profile (addictive behaviour)?

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria for patients :

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

Exclusion Criteria :

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833209

Contacts

Contact: Françoise RADAT, MD

05 56 79 87 11

francoise.radat@chu-bordeaux.fr

Locations

France
CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur	Recruiting
Bordeaux, France, 33076
Contact: Françoise RADAT, MD 05 56 79 87 11 francoise.radat@chu-bordeaux.fr
Contact: Virginie DOUSSET, MD 05 56 79 87 11 virginie.dousset@chu-bordeaux.fr
Principal Investigator: Françoise RADAT, MD
Sub-Investigator: Virginie DOUSSET, MD
C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire	Not yet recruiting
Bordeaux, France, 33076
Contact: Michèle ALLARD, MD michele.allard@chu-bordeaux.fr

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:

Françoise RADAT, MD

University Hospital, Bordeaux

More Information

No publications provided

Responsible Party:	Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00833209 History of Changes
Other Study ID Numbers:	CHUBX 2008/28
Study First Received:	January 29, 2009
Last Updated:	December 9, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

Orbitofrontal cortex
Medication Overuse Headache
Chronic headache
withdrawal

Additional relevant MeSH terms:

Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012