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Compares treatment options for Migraine
Official title A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
ClinicalTrials.gov ID: NCT06602479
What this study is testing
What is MEDI0618?
MEDI0618 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for migraine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this Phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 18 to 70 years of age
- Weight ≥ 40 kg and BMI ≥ 18.0 kg/m2.
- History of migraine headaches with or without aura, with migraine onset at ≤ 50 years of age and for at least 12 months prior to screening.
- At least 12 MHDs over the last 3 months prior to screening.
- Participants must fulfil the following criteria for migraine in prospectively collected baseline information during the 4 consecutive weeks of...
You likely can't join if
- History of migraine sub-types including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
- History of headache other than migraine within 3 months prior to screening.
- History of severe or ongoing allergy/hypersensitivity reactions or history of hypersensitivity to immunisations or immunoglobulins.
- History of any significant psychiatric disorder which could be detrimental to participant safety or could compromise study data interpretation.
- Presence of any clinically significant illness, such as cardiovascular, neurologic (except for non-exclusionary headaches in participants with...
- History of cancer within 5 years of screening, or between screening and randomisation, with the exception of non-metastatic basal cell carcinoma of...
See the full eligibility criteria
- 18 to 70 years of age
- Weight ≥ 40 kg and BMI ≥ 18.0 kg/m2.
- History of migraine headaches with or without aura, with migraine onset at ≤ 50 years of age and for at least 12 months prior to screening.
- At least 12 MHDs over the last 3 months prior to screening.
- Participants must fulfil the following criteria for migraine in prospectively collected baseline information during the 4 consecutive weeks of baseline migraine headache data collection prior to Day 1: (a) ≥ 4 and ≤ 14...
- Participants who fulfil criteria for MOH are eligible for this study.
- History of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes (a) aCGRP-N participants are eligible to receive an aCGRP therapy but must have not yet received aCGRP...
- Participants must be able to distinguish migraine headaches from tension-type headaches.
- Female participants who are not pregnant and do not plan to become pregnant during the study, are not lactating, or are of nonchildbearing potential. FOCBP who are sexually active with a non-sterilised male partner must...
- History of migraine sub-types including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
- History of headache other than migraine within 3 months prior to screening.
- History of severe or ongoing allergy/hypersensitivity reactions or history of hypersensitivity to immunisations or immunoglobulins.
- History of any significant psychiatric disorder which could be detrimental to participant safety or could compromise study data interpretation.
- Presence of any clinically significant illness, such as cardiovascular, neurologic (except for non-exclusionary headaches in participants with migraine), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic...
- History of cancer within 5 years of screening, or between screening and randomisation, with the exception of non-metastatic basal cell carcinoma of the skin, carcinoma in situ of the cervix, or non-progressive prostate...
- Known history of drug or alcohol abuse within 1 year of screening or positive test for drugs of abuse or alcohol at screening or at Day -1.
- History of QT prolongation \> 450 msec (\> 470 msec for participants aged ≥ 65 years) associated with other medications that required discontinuation of that medication.
- Congenital long or short QT syndrome.
- History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite...
- Use of migraine preventive medications within 30 days or 5 half-lives (whichever is longer) prior to screening and throughout the study
- For aCGRP-N participants only: prior use of an aCGRP therapy for acute or preventive treatment.
- Use of opioids or barbiturate containing analgesic \> 2 times/month on average in the 6 months prior to screening for the treatment of pain (opioid administration in an emergency setting may be an exception).
- Use of botulinum toxin (e.g., Botox ®, Dysport®, Jeuveau™, Myobloc®, Xeomin®) for migraine or for any other medical or cosmetic reasons requiring injections in the head, face, or neck during the 4 months prior to...
- Use of an intervention or device (eg, scheduled nerve block, transcranial magnetic stimulation) for treatment of migraine within 2 months of screening.
- Use of prescription or non-prescription, non-biologic drugs, including vitamins and herbal and dietary supplements, within 7 days or 5 half-lives (whichever is longer) prior to screening and throughout the study unless...
- Requires treatment with another biological therapeutic agent including IV immunoglobulin treatment during the course of the study. Prior use of therapeutic antibodies is allowed if that use was \> 5 half-lives of the...
- Therapeutic vaccines are permitted during the study, but ideally, live attenuated vaccines should be administered \> 30 days prior to randomisation and inactivated vaccinations (eg, inactive influenza, COVID-19) should...
- Participation in another clinical study with an IP, including an experimental vaccine, or device, within 5 half-lives of the intervention or 3 months prior to screening, whichever is longer.
- Known hypersensitivity to MEDI0618 or any of the excipients of the product. Other protocol defined inclusion and exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Homestead, Florida, United States
- Lake Mary, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Louisville, Kentucky, United States
- New York, New York, United States
- East Greenwich, Rhode Island, United States
- Summerville, South Carolina, United States
- Austin, Texas, United States
- Crab Orchard, West Virginia, United States
- Mequon, Wisconsin, United States
- Kladno, Czechia
- Prague, Czechia
- Rychnov nad Kněžnou, Czechia
- Glostrup Municipality, Denmark
+ 21 more site(s).
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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Huntsville, Alabama, United States; La Jolla, California, United States; Los Angeles, California, United States; Homestead, Florida, United States; Lake Mary, Florida, United States and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.