Chronic HeadacheO214NCT02302027
Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache
A study testing platinium IRC9LXO2AWQ in people with Chronic Headache, run by Association pour la Recherche au Centre d'Urgence des Céphalées at 1 site in France.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Headache
- What is being tested?
- platinium IRC9LXO2AWQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- One or more failed withdrawal treatment
- analgesic treatment for another reason than headache
- Contraindication of normobaric oxygen therapy
- Contraindication of ketoprofen (rescue therapy)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre d'Urgence des Céphalées, hôpital Lariboisière
Paris, 75010
Caroline Roos, MD, 00 33 1 49 95 89 53, caroline.roos@aphp.fr
Dominique Valade, MD
About this study
Official title: Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers
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.
Read more
The aim of this study is
- verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
- 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
- Conditions
- Chronic Headache
- Being tested
- platinium IRC9LXO2AWQ
- Keywords
- withdrawal therapy, oxygen therapy
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platinium IRC9LXO2AWQDevice
high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: platinium IRC9LXO2AWQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
Measured: 6th month
Secondary outcomes (7)
number of headache days per month
Measured: 6th month
number of session of oxygen during the 6 months
Measured: 6th month
number of rescue medication taking on the 6 months
Measured: 6th month
Hospital Anxiety and Depression Scale
Measured: 1st month, 2d month and 3rd month
Headache Impact Test- 6
Measured: 1st, 2d and 3rd month
Patient Global Impressions of Change Scale
Measured: 1st, 2d, 3rd, 4th, 5th and 6th month
Migraine Disability Assessment Questionnaire Scale
Measured: 3rd and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour la Recherche au Centre d'Urgence des Céphalées
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline ROOS, Association pour la Recherche au Centre d'Urgence des Céphalées
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302027
- Sponsor's protocol ID
- ARCUC
- Acronym
- O214
- Status last verified
- Jan 2016
- First submitted
- 24 Nov 2014
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15689304Lanteri-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.
PubMed 16305603Evers 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.
PubMed 20298963
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers
- ClinicalTrials.gov ID
- NCT02302027
- Acronym / sponsor ID
- O214 / ARCUC
- Conditions
- Chronic Headache
- Keywords
- withdrawal therapy, oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Association pour la Recherche au Centre d'Urgence des CéphaléesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platinium IRC9LXO2AWQ | Experimental | Device: platinium IRC9LXO2AWQNormobaric oxygen therapy with high flow concentrator to treat headaches attacks, 30 minutes of oxygene inhalation with mask, 9l/minute, no frequency limitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- One or more failed withdrawal treatment
- analgesic treatment for another reason than headache
- Contraindication of normobaric oxygen therapy
- Contraindication of ketoprofen (rescue therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platinium IRC9LXO2AWQhigh flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm | Device | platinium IRC9LXO2AWQ |
Primary outcome
percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
Time frame: 6th month
7 secondary outcomes
number of headache days per month
Time frame: 6th month
number of session of oxygen during the 6 months
Time frame: 6th month
number of rescue medication taking on the 6 months
Time frame: 6th month
Hospital Anxiety and Depression Scale
Time frame: 1st month, 2d month and 3rd month
Headache Impact Test- 6
Time frame: 1st, 2d and 3rd month
Patient Global Impressions of Change Scale
Time frame: 1st, 2d, 3rd, 4th, 5th and 6th month
Migraine Disability Assessment Questionnaire Scale
Time frame: 3rd and 6th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Results publication: PubMed 15689304Kavuk 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.
- Results publication: PubMed 16305603Lanteri-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.
- Results publication: PubMed 20298963Evers 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.
Related trials for Chronic Headache
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
MMA Embolization for Refractory Chronic Migraine
Migraine Disorders
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platinium IRC9LXO2AWQ in people with Chronic Headache, run by Association pour la Recherche au Centre d'Urgence des Céphalées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Roos, MD (00 33 1 49 95 89 53, caroline.roos@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases (time frame: 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302027, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.