NCT02302027

Brief Summary

Chronic headache is most often associated with drug abuse and medication overuse headache (MOH) is the main complication of migraine disease results in chronic daily headache. The first phase of treatment consists of drug withdrawal . The second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use. The aim of this study is

  1. 1.verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
  2. 2.use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

November 24, 2014

Last Update Submit

January 6, 2016

Conditions

Chronic Headache

Keywords

withdrawal therapyoxygen therapy

Outcome Measures

Primary Outcomes (1)

  • percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases

    6th month

Secondary Outcomes (7)

  • number of headache days per month

    6th month

  • number of session of oxygen during the 6 months

    6th month

  • number of rescue medication taking on the 6 months

    6th month

  • Hospital Anxiety and Depression Scale

    1st month, 2d month and 3rd month

  • Headache Impact Test- 6

    1st, 2d and 3rd month

  • +2 more secondary outcomes

Study Arms (1)

platinium IRC9LXO2AWQ

EXPERIMENTAL

Normobaric oxygen therapy with high flow concentrator to treat headaches attacks, 30 minutes of oxygene inhalation with mask, 9l/minute, no frequency limitation

Device: platinium IRC9LXO2AWQ

Interventions

platinium IRC9LXO2AWQDEVICE

high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 \* 67 \* 36 cm

platinium IRC9LXO2AWQ

Eligibility Criteria

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

You may qualify if:

  • Migrainous according to the criteria of the International Headache Society
  • Medication-overuse headaches according of the International Headache Society
  • No prophylaxis treatment or same prophylaxis treatment from more than one month
  • Signed informed consent

You may not qualify if:

  • Pregnancy
  • One or more failed withdrawal treatment
  • analgesic treatment for another reason than headache
  • Contraindication of normobaric oxygen therapy
  • Contraindication of ketoprofen (rescue therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Urgence des Céphalées, hôpital Lariboisière

Paris, 75010, France

RECRUITING

Related Publications (3)

  • Kavuk I, Katsarava Z, Selekler M, Sayar K, Agelink MW, Limmroth V, Diener HC. Clinical features and therapy of medication overuse headache. Eur J Med Res. 2004 Dec 22;9(12):565-9.

    PMID: 15689304RESULT

  • Lanteri-Minet M, Valade D, Geraud G, Chautard MH, Lucas C. Migraine and probable migraine--results of FRAMIG 3, a French nationwide survey carried out according to the 2004 IHS classification. Cephalalgia. 2005 Dec;25(12):1146-58. doi: 10.1111/j.1468-2982.2005.00977.x.

    PMID: 16305603RESULT

  • Evers S, Marziniak M. Clinical features, pathophysiology, and treatment of medication-overuse headache. Lancet Neurol. 2010 Apr;9(4):391-401. doi: 10.1016/S1474-4422(10)70008-9.

    PMID: 20298963RESULT

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Caroline Roos, MD

CONTACT

00 33 1 49 95 89 53caroline.roos@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 24, 2014

First Posted

November 26, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

FR(1)