Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02302027
Other study ID # ARCUC
Secondary ID
Status Recruiting
Phase N/A
First received November 24, 2014
Last updated January 6, 2016
Start date December 2014
Est. completion date October 2016

Study information

Verified date January 2016
Source Association pour la Recherche au Centre d'Urgence des Céphalées
Contact Caroline Roos, MD
Phone 00 33 1 49 95 89 53
Email caroline.roos@aphp.fr
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial 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. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator

2. use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period.

It is a feasibility pilot study in chronic headache with or without medication-overuse. All patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". The subsequent attacks will be treated with NOT from a high-flow concentrator

Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of patients who accepted NOT during the withdrawal phase then to treat attacks.

Secondary endpoints. Efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake).

Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months

Effective : 30 patients


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Pregnancy

- One or more failed withdrawal treatment

- analgesic treatment for another reason than headache

- Contraindication of normobaric oxygen therapy

- Contraindication of ketoprofen (rescue therapy)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
platinium IRC9LXO2AWQ
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm

Locations

Country Name City State
France Centre d'Urgence des Céphalées, hôpital Lariboisière Paris

Sponsors (1)

Lead Sponsor Collaborator
Association pour la Recherche au Centre d'Urgence des Céphalées

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

Lantéri-Minet M, Valade D, Géraud 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases 6th month No
Secondary number of headache days per month 6th month No
Secondary number of session of oxygen during the 6 months 6th month No
Secondary number of rescue medication taking on the 6 months 6th month No
Secondary Hospital Anxiety and Depression Scale 1st month, 2d month and 3rd month No
Secondary Headache Impact Test- 6 1st, 2d and 3rd month No
Secondary Patient Global Impressions of Change Scale 1st, 2d, 3rd, 4th, 5th and 6th month No
Secondary Migraine Disability Assessment Questionnaire Scale 3rd and 6th month No
See also
  Status Clinical Trial Phase
Recruiting NCT05414513 - The Turkish Fear of Pain Questionnaire
Not yet recruiting NCT06077747 - Lumbar Vein Embolization for Chronic Headaches With Nutcracker Physiology N/A
Completed NCT02514148 - Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients N/A
Not yet recruiting NCT00897780 - Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache N/A
Completed NCT00228267 - Propofol Injection for Daily Headache Phase 2
Completed NCT02684916 - Chiropractic Treatment for Headache Among Children Aged 7-14 N/A
Not yet recruiting NCT05613582 - The Effectiveness of Transcranial Direct Current Stimulation as Adjunctive Treatment for Chronic Daily Headache in Systemic Lupus Erythematosus N/A
Completed NCT02440997 - A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache N/A
Completed NCT01314768 - Brief Intervention for Medication Overuse Headache N/A
Enrolling by invitation NCT06127888 - Impementation of the Exercise Recommendations for the Treatment of Primary Headaches: A Qualitative Approach to the Headache Units in Catalonia
Completed NCT00417742 - Project CHEER (Comprehensive Headache Evaluation, Education, Relief) N/A
Terminated NCT02141568 - Effectiveness of Mind-Body Interventions for Frequent Attendees Suffering From Medically Unexplained Symptoms (MUS) N/A
Recruiting NCT04195685 - Neurofeedback Impact on Veterans With mTBI N/A
Completed NCT03080779 - Long Term Outcomes After Accidental Dural Puncture ADP Study
Not yet recruiting NCT00286923 - Does Topiramate Adjust the Excitability of the Brain in Migraine Sufferers? N/A
Completed NCT04696627 - Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.
Completed NCT03503734 - Integrated Care for Migraine and Chronic Tension-type Headaches
Recruiting NCT02753933 - Direct Access to MRI and Neurology Referrals for the Management of Patients With Chronic Headache. N/A