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Prevention study for Episodic Migraine
Official title A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
ClinicalTrials.gov ID: NCT06625060
What this study is testing
What is IPN10200?
IPN10200 is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for episodic 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
- A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. 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 80
You may be able to join if
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. Participant has...
- Male or female ≥18 to 80 years of age at the time of signing the informed consent;
- Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit;
- Diagnosis of migraine at ≤50 years of age;
- Participants in the EM group: History of EM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≤14 headache days in the 4...
You likely can't join if
- History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal...
- Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH);
- Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study...
- Risk of self-harm or harm to others as evidenced by past suicidal behaviour or endorsing items 3, 4, or 5 on the C-SSRS at screening or Day 1.
- Participants presenting with a swallowing disorder of any origin which might be exacerbated by botulinum toxin treatment, such as: \- Grade 3 or 4 on...
- Clinically relevant skin condition or infection that could interfere with injection of study intervention;
See the full eligibility criteria
Who can join
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. Participant has provided written informed consent and signed privacy/data protection...
- Male or female ≥18 to 80 years of age at the time of signing the informed consent;
- Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit;
- Diagnosis of migraine at ≤50 years of age;
- Participants in the EM group: History of EM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≤14 headache days in the 4 weeks prior to randomisation on study Day 1 based on information...
- Participants in the CM group: History of CM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≥15 headache days in the 4 weeks prior to randomisation on study Day 1 based on information...
- Participant with a history of use of at least one preventive treatment for migraine.
What rules you out
- History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua or new daily...
- Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH);
- Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation;
- Risk of self-harm or harm to others as evidenced by past suicidal behaviour or endorsing items 3, 4, or 5 on the C-SSRS at screening or Day 1.
- Participants presenting with a swallowing disorder of any origin which might be exacerbated by botulinum toxin treatment, such as: \- Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing...
- Clinically relevant skin condition or infection that could interfere with injection of study intervention;
- Participant has any medical condition or situation that would make them unsuitable for participation in the study;
- Participant receiving more than one allowable concomitant migraine preventive treatment;
- Known history of an inadequate response to \>4 medications prescribed for the prevention of migraine (2 of which have different mechanisms of action to botulinum toxin);
- Use of any of the following medications in the specified timeframe prior to the screening visit:
- Botulinum toxin for migraine within 24 weeks (or for any other medical/aesthetic reason within 16 weeks);
- Prior use of mAbs blocking CGRP pathway within 12 weeks for preventative treatment of migraine
- Prior use of oral CGRP receptor antagonist (gepants) for preventative treatment of migraine within 2 weeks;
- Anaesthetic or steroid injection in any region targeted for treatment with study medication within 4 weeks;
- Use of cannabidiol or other types of cannabinoids within 30 days;
- Use of medical device to treat migraine within 4 weeks (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve...
- Use of other intervention to treat migraine that is assessed to interfere with study evaluations within 4 weeks (e.g. acupuncture in the head and neck region, cranial traction, nociceptive trigeminal inhibition...
- Use of opioids or barbiturates for more than 2 days/month within the last 4 weeks.
- Concurrent participation in another treatment clinical study (or within specified timeframe according to national or local legislation or requirements);
- Diagnosis of other significant pain disorders that could confound the assessment of headaches/migraines or interfere with study participation, including but not limited to chronic pain disorders such as fibromyalgia...
- Pregnant women, nursing women, premenopausal women, or WOCBP (i.e. not surgically sterile or 1 year postmenopausal) not willing to practice an acceptable contraceptive method, at the beginning of the study and for a...
- Male people who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide for a minimum of 12 weeks following the initial blinded administration of...
- History of alcohol or drug abuse within 5 years of the screening visit (excluding medication overuse for headache);
- Body mass index (BMI) ≥35 kg/m² at the screening visit;
- Known clinically significant hypersensitivity to any of the study drugs, excipients or materials used to administer the study drug;
- Patients who, in the clinician's judgment, are actively suicidal, and therefore, deemed to be at significant risk for suicide.
- A diagnosis of a neuromuscular disorder or respiratory disorder, such as myasthenia gravis, Lambert-Eaton syndrome or amyotrophic lateral sclerosis that in the opinion of the investigator would compromise the safety of...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Chandler, Arizona, United States
- Little Rock, Arkansas, United States
- Apple Valley, California, United States
- Carlsbad, California, United States
- Encino, California, United States
- Fresno, California, United States
- Fullerton, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Alamitos, California, United States
- Newport Beach, California, United States
- Pasadena, California, United States
- San Diego, California, United States
- Thousand Oaks, California, United States
- West Hills, California, United States
- Fort Collins, Colorado, United States
- Stamford, Connecticut, United States
- Boca Raton, Florida, United States
+ 107 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 80 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; Chandler, Arizona, United States; Little Rock, Arkansas, United States; Apple Valley, California, United States; Carlsbad, California, United States and 121 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.