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Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine (ATOM)
EU CTIS ID: 2024-517128-21-02
What this study is testing
The percentage of subjects who become pain free at 2 hours(h) after treatment, before the use of any rescue medication is the primary measure of efficacy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the ICHD-33 criteria based on medical records and/or patient selfreport
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Aged 18 to 65 years upon entry into screening
- Not more than 12 attacks per month with moderate to severe headache pain in each of the previous 3 months.
You likely can't join if
- Greater than 50 years of age at migraine onset
- Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Start of new preventive migraine treatment within the last two months
- Change in dosage of ongoing preventive migraine treatment within the last two months
- Current preventive treatment with monoclonal antibodies targeting calcitonin gene related peptide (CGRP) or CGRP receptors, or current use of small-molecule CGRP receptor antagonist (e.g. erenumab, fremanezumab, galcanezumab, atogepant or rimegepant)
See the full eligibility criteria
Who can join
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the ICHD-33 criteria based on medical records and/or patient selfreport
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Aged 18 to 65 years upon entry into screening
- Not more than 12 attacks per month with moderate to severe headache pain in each of the previous 3 months.
What rules you out
- Greater than 50 years of age at migraine onset
- Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Start of new preventive migraine treatment within the last two months
- Change in dosage of ongoing preventive migraine treatment within the last two months
- Current preventive treatment with monoclonal antibodies targeting calcitonin gene related peptide (CGRP) or CGRP receptors, or current use of small-molecule CGRP receptor antagonist (e.g. erenumab, fremanezumab, galcanezumab, atogepant or rimegepant)
- Changes in treatment with Selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) within the last two months
- Use of the following medication within 30 days prior to screening: o Strong and moderate cytochrome P450 3A4 (CYP3A4) inhibitors, including but not limited to systemic (oral/IV) itraconazole, ketoconazole, fluconazole; erythromycin, clarithromycin, telithromycin; diltiazem, verapamil; aprepitant; cyclosporine; nefazodone; cimetidine; quinine; and HIV protease inhibitors o Strong and moderate CYP3A4 inducers, including but not limited to barbiturates (eg, phenobarbital and primidone), systemic (oral/IV) glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, rifampin, rifabutin, and St. John’s wort o Inhibitors of the BCRP (breast cancer resistance protein) transporter (eg, rifampicin) o Drugs with narrow therapeutic margins (eg, digoxin, warfarin)
- Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product.
- Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product.
- History of cluster headache or hemiplegic migraine headache
- Evidence of current pregnancy or breastfeeding per subject self-report or medical records
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge
- Inability to differentiate between migraine from other headaches
- Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per months in the previous 3 months
- Has a history of migraine aura with diplopia or impairment of levels of consciousness, hemiplegic migraine, or retinal migraine.
- Required hospital treatment of a migraine attack 3 or more times in the previous 6 months.
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Has a chronic non-headache pain condition requiring daily pain medication
- Has a history of any prior gastrointestinal conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.