Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platinium IRC9LXO2AWQ | Device | high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases | 6th month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Roos, MD | Contact | 00 33 1 49 95 89 53 | caroline.roos@aphp.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Urgence des Céphalées, hôpital Lariboisière | Recruiting | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15689304 | Result | 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. | |
| 16305603 | Result | 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. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 9, 2018 | |
| Reset | Mar 5, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 9, 2018 | Mar 5, 2019 |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6th month |
| Hospital Anxiety and Depression Scale | 1st month, 2d month and 3rd month |
| Headache Impact Test- 6 | 1st, 2d and 3rd month |
| Patient Global Impressions of Change Scale | 1st, 2d, 3rd, 4th, 5th and 6th month |
| Migraine Disability Assessment Questionnaire Scale | 3rd and 6th month |
| 20298963 | Result | 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. |