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Migraine ER drug trial halted early – no clear results

NCT ID NCT04726592

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether adding clorazepate (a sedative) to standard migraine medications could provide faster pain relief for people having a migraine attack in the emergency room. The trial included 323 adults with moderate to severe migraine. However, the study was terminated early, so we don't have enough data to know if it worked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clorazepate (a sedative) plus usual migraine drugs (ketoprofen and metoclopramide)
What this could lead to
If it had worked, this could have pointed to a new option for quickly easing migraine pain in the emergency room.
What could go wrong
The trial was terminated early, so we don't have clear evidence it works. It was also a small, single-center study, so results may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

323 people

The number who actually took part.

Started

Jul 2021

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Headache headache disorder migraine disorder migraine with aura migraine without aura

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Headache Migraine Migraine with aura Migraine without aura

Contacts and locations

Locations

  • Hôpital Lariboisière

    Paris, Île-de-France Region, 75010, France

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