Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
70
Countries
1
Sites
5
MIGRAINE
To Study the effectiveness of high-throughput oxygen therapy on migraine attacks in emergency departments.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 11 May 2023 → ongoing
- Decision date (initial)
- 2023-01-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To Study the effectiveness of high-throughput oxygen therapy on migraine attacks in emergency departments.
Secondary objectives 5
- Evaluate the effectiveness of high-throughput oxygen therapy on any associated symptoms (such as nausea, photophobia, neurological disorders)
- Assess possible recurrence of pain at 60 and 90 minutes
- Evaluate the occurrence of side effects
- Evaluate the time spent in emergency rooms
- Evaluating the use of relief analgesics
Conditions and MedDRA coding
MIGRAINE
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10010108 | Common migraine | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients 18 years of age or older
- Admitted to the emergency department for migraine-evocative headache according to the criteria of the International Classification of Headaches 3rd edition ICHD-3
- Written consent to participate after being informed of the study
- Pain intensity at least equal to 6 assessed by the patient’s verbal pain self-assessment
Exclusion criteria 7
- Patients with risk of respiratory failure by hypercapnia (COPD, cystic fibrosis, morbid obesity, malformation of the chest wall, neuromuscular disorder)
- Patients under legal protection
- Patients treated with triptan in the last 2 weeks
- Patients who consumed NSAIDs in the hour prior to physician review
- Disabling migraine crisis during for more than 72 hours
- History of paraquat poisoning
- History of treatment with amiodarone, bleomycin or nitrofurantoin
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PProportion of subjects with a score less than or equal to 3 on the Simple Numerical Scale (SLA) of verbal self-assessment of patient pain (0-10), 30 minutes after the start of inhaled treatment.
Secondary endpoints 5
- Disappearance of any associated symptoms (nausea, photophobia, etc.): frequencies at t=0, 30, 60 and 90 minutes after the start of the oxygen or placebo session (air)
- Verbal Patient Pain Self-Assessment SLAs at 60 and 90 minutes (assess possible recurrence of pain)
- Frequency of occurrence of side effects
- Average time spent in emergency rooms
- Frequency of emergency painkillers
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Oxigen medicinal comprimat gaz medicinal comprimat
PRD3596354 · Product
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 450 l litre(s)
- Max total dose
- 450 l litre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- 4800/2012/01
- MA holder
- SIAD ROMANIA SRL
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Medicinal Air Synthetic, 21.75% v/v medicinal gas, compressed
PRD713823 · Product
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 450 l litre(s)
- Max total dose
- 450 l litre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AN05 — -
- Marketing authorisation
- PL 35326/0005
- MA holder
- SOL SPA
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Julie CONTENTI
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Céline CELLIER-COËLLE
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 70 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Les Hopitaux De Chartres
Accueil Urgences, 4 Rue Claude Bernard, 28630, Le Coudray
Clinique Les Cèdres
Emergency, Route de Mondonville, 31700, Cornebarrieu
Clinique Croix du Sud
Emergency, 52 chemin de Ribaute, 31130, Quint Fonsegrives
Centre Hospitalier Regional De Marseille
Emergency, 144 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Nice
Urgences, 151 Route De Saint Antoine, 06200, Nice
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-05-11 | 2023-10-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2022-501133-23-00_Protocole_MiOx_FP | 2.0 |
| Recruitment arrangements (for publication) | 2022-501123-33-00_RECRUTEMENT_V0_20220617_MiOx | 0 |
| Recruitment arrangements (for publication) | 2022-501123-33-00_RECRUTEMENT_V01_20221107_MiOx | 01 |
| Recruitment arrangements (for publication) | 2022-501133-23-00_ADDITIONNEL_V0_20220617_For Pub | 1 |
| Recruitment arrangements (for publication) | 2022-501133-23-00_ADDITIONNEL_V0_20220617_For Pub | 1 |
| Subject information and informed consent form (for publication) | 2022-501133-23-00_NICE MiOx_V0_20220315_FP | 0 |
| Subject information and informed consent form (for publication) | 2022-501133-23-00_NICE MiOx_V01_20221107_FP | 01 |
| Subject information and informed consent form (for publication) | 2022-501133-23-00_NICE MiOx_V02_Clean_20221118_FP | 1.0 |
| Subject information and informed consent form (for publication) | 2022-501133-23-00_NICE Proche MiOx_V0_20221107_FP | 0 |
| Subject information and informed consent form (for publication) | 2022-501133-23-00_NICE Proche MiOx_V01_Clean_20221118_FP | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2022-501133-23-00_RCP_Oxygene Medicinal_MiOx_RFI | 1 |
| Synopsis of the protocol (for publication) | 2022-501133-23-00_Resume_MiOx_FP | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-19 | France | Acceptable 2023-01-10
|
2023-01-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-15 | France | Acceptable 2024-08-30
|
2024-09-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-02 | France | Acceptable 2025-01-16
|
2025-02-05 |