Headache, Migraine, Migraine With Aura, Migraine Without Aura
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room
Detailed description
Each patient will receive the usual migraine treatment: IV ketoprofen 100 mg and, if he suffers nausea and/or vomiting, additional IV metoclopramide 10 mg. Depending on randomization assignment, patient will receive additional placebo (standard treatment arm) or additional IV Clorazepate 20 mg (study arm). The central pharmacy will be responsible for preparing the medications, using a double-blind protocol.
Interventions
DRUGMetoclopramide
Metoclopramide 10 mg IV
DRUGClorazepate Dipotassium
Clorazepate Dipotassium : 20 mg intravenous injection
DRUGPlacebo
Placebo IV
DRUGKetoprofen
Ketoprofen 100 mg IV
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 70 * Patient suffering migraine or probable migraine (diagnosis made by neurologist according to IHCD3) * Present migraine attack lasting ≤ 72 hours * Headache intensity moderate or severe on the verbal ordinal scale (4 levels: no headache, mild, moderate or severe) * Patient requiring parenteral treatment * Affiliation to the French Health-care System sécurité sociale
Exclusion criteria
* abnormalities of neurological exam, seizure, fever (≥ 38°C), and/or SBP≥180 and/or DBP≥110 mmHg * suspicion of secondary headache * inability to understand the consent or scales * pregnancy or breast-feeding * known respiratory or liver insufficiency * acute alcohol consumption or alcoholism * myasthenia * Patient requiering treatment with sumatriptan SC, particularly in the event of failure of an anti-inflammatory drug at an effective dose taken within 6 hours * recent use of benzodiazepines (\< 24h diazepam, clonazepam, clorazepate ; \< 6h alprazolam, lorazepam, midazolam) * recent use of pain killers (\< 2h) * contraindication to any of the investigational medication * contraindication to intravenous access * previous participation to this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief | 2 hours | Percentage of patients pain-relief 2 hours after administration of the treatment |
Countries
France
Outcome results
None listed