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Tests treatment safety and results for Episodic Migraine
Official title Efficacy of Nerve Blocks for Episodic Migraine
ClinicalTrials.gov ID: NCT05734625
What this study is testing
What is Bupivacaine HCl 0.5% Injectable Solution?
Bupivacaine HCl 0.5% Injectable Solution is an investigational medicine, given as an once-weekly infusion into a vein, 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
- The purpose of this study is to see how well blocking two to ten of the scalp nerves (that give feeling to the scalp and are painful during migraine headaches) with bupivacaine anesthetic (numbing medication) and low dose methylprednisolone (cortisone-like medicine or steroid) work for treating and preventing migraines. Our hypothesis is that the pain of most episodic migraine headaches can be eliminated and prevented for months by blocking the nerves that give pain sensation during a migraine.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 times a month at a severity of 5/10...
- Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial.
- History fits the definition of migraine:
- Have a history of episodic headache lasting 4-72 hours with at least 2 of the 4 following: unilateral location, pulsating/throbbing quality...
- Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels...
You likely can't join if
- Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
- Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase...
- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- Intrauterine device (IUD)
- Total hysterectomy or tubal ligation
See the full eligibility criteria
- Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 times a month at a severity of 5/10 pain level or greater.
- Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial.
- History fits the definition of migraine:
- Have a history of episodic headache lasting 4-72 hours with at least 2 of the 4 following: unilateral location, pulsating/throbbing quality, moderate-severe intensity, aggravation by/causing avoidance of routine...
- Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels better), phonophobia (seek out a quiet environment during a headache...
- Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
- Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception. Acceptable...
- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- Intrauterine device (IUD)
- Total hysterectomy or tubal ligation
- Abstinence (no sex)
- Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or corticosteroids
- Previously received peripheral nerve blocks (PNBs)
- Currently anticoagulated
- Currently receiving Botox for migraine prophylaxis
- Started on new medication in the prior two months with known migraine-preventive how well it works or planning to start any new medication during the study
- Currently using opiate medications for pain
- History of drug or alcohol abuse within the prior two years
- Have unstable medical or surgical diseases that could impair participation in this study
- History of craniotomies, burr holes, skull fractures and/or have open skull defects
- Patients with implanted nerve stimulators or shunts
- Phobia of needles
- Active skin or soft tissue infection overlying injection sites
- Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. 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.