Study of the efficacy of dipotassium clorazepate in the treatment of migraine in the emergency department

Phase 1

Active, not recruiting

• Conditions: Adults of full age, excluding pregnant or breastfeeding women, admitted to the CUC for headaches; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-000503-16-FR
• Lead Sponsor: Assistance Publique- Hôpiaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-08
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 420

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified