Adults of full age, excluding pregnant or breastfeeding women, admitted to the CUC for headaches
Conditions
Interventions
Trade Name: Tranxène
Product Name: Tranxene
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
INN or Proposed INN: Clorazepate dipotassique
Other descriptive name: CHLORAZEPATE
Sponsors
Assistance Publique- Hôpiaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient 18 to 70 years old - Patient with a migraine or probable migraine, with or without aura, episodic or chronic, meeting the IHCD3 (International Classification of Headache Disorders 3rd edition) criteria, the diagnosis being made by a neurologist. - Crisis of a duration = 72h - Intensity of moderate or severe headache on the ordinal verbal pain scale - Patient affiliated to a social security scheme Translated with www.DeepL.com/Translator (free version) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 420 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 420
Exclusion criteria
Exclusion criteria: - Abnormalities of neurological examination, coma attack and/or fever (temperature = 38°C), PAS=180 and/or PAD=110 mmHg - Suspicion of secondary headache - Inability to understand informed consent or questionnaires - Pregnancy and breastfeeding - Known respiratory insufficiency and/or sleep apnea - Known liver failure - Acute or chronic alcohol poisoning - Myasthenia gravis - Recent use of benzodiazepines o < 24h for long-acting benzodiazepines (diazepam, clonazepam, CDP) o < 6 hours for shorter acting benzodiazepines (alprazolam, lorazepam, midazolam) - Taking recent analgesics (<2h) - Allergy, or known hypersensitivity and/or other contraindications to CDP, another benzodiazepine, ketoprofen and/or metoclopramide - Contraindication to the use of an intravenous approach - Patient who has already participated in this study - Patient participating in other research involving the human person
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the value of CDP IV as an add-on to the standard treatment of migraine attacks (ketoprofen +/- metoclopramide) compared to placebo for the relief of migraine headache in the emergency department.;Secondary Objective: - Evaluate the efficacy of CDP IV compared to placebo o on complete headache relief o on the recurrence of headache at 24 hours o on the need for rescue treatment o on the intensity of acute anxiety at 2 and 24 hours after administration o on the signs associated with headaches (nausea/vomiting, photophobia, phonophobia) o on the frequency and intensity of metoclopramide-induced akathisia within 2 hours of administration. o on the memory of the stay in the emergency room o on the impact of the crisis o on overall patient satisfaction - Assess CDP tolerance (drowsiness) Translated with www.DeepL.com/Translator (free version);Primary end point(s): Percentage of patients reporting partial or complete relief at 2 hours ("pain relief"): change from severe or moderate intensity to mild or absent on the EVO (Ordinal Verbal Pain Scale), 4-level scale: severe-moderate-light-absent.;Timepoint(s) of evaluation of this end point: 2 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients reporting total relief at 2 hours ("pain free"): change from severe or moderate intensity to mild or no EVO - Percentage of patients with sustained pain free: complete relief at 2 hours (EVO) with no recurrence of moderate or severe headache and no pain medication at 24 hours. - Change in headache intensity from T0 (IV administration) to T+2h and T+24h, as assessed by the Analogue Verbal Pain Scale 0-10 (AVS). - Percentage of patients reporting total relief within 2 hours of their most troublesome migraine symptom among nausea, photophobia and phonophobia - Percentage of Patients Requiring Additional Crisis Treatment in the Emergency Department (Salvage Treatment) - Variation in the intensity of acute anxiety at 2 hours and 24 hours: Visual Anxiety Analog Scale (VASnx) - Akathisia scale (no agitation, slightly agitated, clearly agitated) at 2 hours - Sleepiness Score: 3-level ordinal scale (not drowsy, slightly drowsy but able to function normally or too drowsy to function normally) at 2:00 a.m. and question: "Have you slept since the treatments were administered? "at 2:00 a.m. - Transient anterograde amnesia scale: verbal analogue scale between 0 and 10 at 24 hours - Impact Scale: 4-level ordinal scale: absent, mild, moderate, severe - Composite overall satisfaction scores : o Patient global impression of change (PGIC) scale between 1 and 7, from 1 = significant improvement to 7 = significant worsening at 2hrs. o Dichotomous criterion "would you like to receive the same treatment the next time you go to the emergency room" at 24 hrs. ;Timepoint(s) of evaluation of this end point: 24h | — |
Countries
France
Contacts
Public ContactLaura Blanchet/ Karine SEYMOUR
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed