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Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room

Primary Purpose

Migraine, Migraine Without Aura, Migraine With Aura

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Clorazepate Dipotassium
Placebo
Ketoprofen
Metoclopramide
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital LariboisièreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control arm

Experimental arm

Arm Description

placebo and standard care : Placebo IV Ketoprofen 100 mg IV (if nausea-vomiting) Metoclopramide 10 mg IV(if nausea-vomiting)

clorazepate and standard care : Clorazepate 20 mg IV Ketoprofen 100 mg IV (if nausea-vomiting) Metoclopramide 10 mg IV(if nausea-vomiting)

Outcomes

Primary Outcome Measures

Pain relief
Percentage of patients "pain-relief" 2 hours after administration of the treatment

Secondary Outcome Measures

Full Information

First Posted
January 24, 2021
Last Updated
September 6, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04726592
Brief Title
Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
Official Title
Randomized Double Blinded Monocentric Study Evaluating the Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Migraine Without Aura, Migraine With Aura, Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
placebo and standard care : Placebo IV Ketoprofen 100 mg IV (if nausea-vomiting) Metoclopramide 10 mg IV(if nausea-vomiting)
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
clorazepate and standard care : Clorazepate 20 mg IV Ketoprofen 100 mg IV (if nausea-vomiting) Metoclopramide 10 mg IV(if nausea-vomiting)
Intervention Type
Drug
Intervention Name(s)
Clorazepate Dipotassium
Other Intervention Name(s)
TRANXENE
Intervention Description
Clorazepate Dipotassium : 20 mg intravenous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo IV
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Intervention Description
Ketoprofen 100 mg IV
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Intervention Description
Metoclopramide 10 mg IV
Primary Outcome Measure Information:
Title
Pain relief
Description
Percentage of patients "pain-relief" 2 hours after administration of the treatment
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme Dr MAWET
Phone
01 49 95 24 77
Ext
+33
Email
jerome.mawet@aphp.fr
Facility Information:
Facility Name
Hôpital Lariboisière
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme JM MAWET, Dr
Phone
01 49 95 24 77
Ext
+33
Email
jerome.mawet@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room

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