MigrainePhase 3CLORMIGNCT04726592
Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
A Phase 3 study testing Clorazepate Dipotassium, Ketoprofen and Metoclopramide in people with Migraine and Migraine Without Aura, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine, Migraine Without Aura, Migraine With Aura
- What is being tested?
- Clorazepate Dipotassium, Ketoprofen and Metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2021to 10 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blinded Monocentric Study Evaluating the Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
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
Read the 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.
- Conditions
- Migraine, Migraine Without Aura, Migraine With Aura, Headache
- Being tested
- Clorazepate Dipotassium, Placebo, Ketoprofen, Metoclopramide
- Medical subject headings
- Migraine Disorders, Migraine without Aura, Migraine with Aura, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clorazepate DipotassiumDrug
Also called TRANXENE
Clorazepate Dipotassium : 20 mg intravenous injection
PlaceboDrug
Placebo IV
KetoprofenDrug
Ketoprofen 100 mg IV
MetoclopramideDrug
Metoclopramide 10 mg IV
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | placebo and standard care :
* Placebo IV
* Ketoprofen 100 mg IV (if nausea-vomiting)
* Metoclopramide 10 mg IV(if nausea-vomiting) Receives: Drug: Placebo; Drug: Ketoprofen; Drug: Metoclopramide |
| Experimental arm | Experimental | clorazepate and standard care :
* Clorazepate 20 mg IV
* Ketoprofen 100 mg IV (if nausea-vomiting)
* Metoclopramide 10 mg IV(if nausea-vomiting) Receives: Drug: Clorazepate Dipotassium; Drug: Ketoprofen; Drug: Metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Percentage of patients "pain-relief" 2 hours after administration of the treatment
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start8 Jul 2021
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Why it stopped: It has been determined that continuing with enrollments in this study is no longer justified due to the lack of significant impact on the expected outcomes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726592
- Sponsor's protocol ID
- P170903J
- Acronym
- CLORMIG
- Status last verified
- Oct 2024
- First submitted
- 24 Jan 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blinded Monocentric Study Evaluating the Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
- ClinicalTrials.gov ID
- NCT04726592
- Acronym / sponsor ID
- CLORMIG / P170903J
- Conditions
- Migraine, Migraine Without Aura, Migraine With Aura, Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It has been determined that continuing with enrollments in this study is no longer justified due to the lack of significant impact on the expected outcomes.
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Drug: Placebo, Drug: Ketoprofen, Drug: Metoclopramideplacebo and standard care : * Placebo IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting) |
| Experimental arm | Experimental | Drug: Clorazepate Dipotassium, Drug: Ketoprofen, Drug: Metoclopramideclorazepate and standard care : * Clorazepate 20 mg IV * Ketoprofen 100 mg IV (if nausea-vomiting) * Metoclopramide 10 mg IV(if nausea-vomiting) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clorazepate DipotassiumAlso: TRANXENEClorazepate Dipotassium : 20 mg intravenous injection | Drug | Experimental arm |
| PlaceboPlacebo IV | Drug | Control arm |
| KetoprofenKetoprofen 100 mg IV | Drug | Control arm, Experimental arm |
| MetoclopramideMetoclopramide 10 mg IV | Drug | Control arm, Experimental arm |
Primary outcome
Pain relief
Time frame: 2 hours
Percentage of patients "pain-relief" 2 hours after administration of the treatment
Results and safety
The study was stopped early (reason given: It has been determined that continuing with enrollments in this study is no longer justified due to the lack of significant impact on the expected outcomes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clorazepate Dipotassium, Ketoprofen and Metoclopramide in people with Migraine and Migraine Without Aura, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It has been determined that continuing with enrollments in this study is no longer justified due to the lack of significant impact on the expected outcomes.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.