Today we’re going to cover the first article in a two-part series that takes a look at the ongoing studies and clinical trials specific to management of migraine in adults, including acute migraine treatment and migraine prevention (both chronic migraine prevention and episodic migraine prevention).
For Part 1 we’ll be starting with Acute Migraine Treatment of Adults. The below list was curated by assessing the ongoing phase 3 trials for migraine treatments, specific for adults, and based in the United States. The dates provided are estimates, and subject to change. The list is separated by studies that have recent results posted (12 months or less), and those without results yet posted.
This article marks the beginning of a series that will provide previews of upcoming innovations within a given topic. We will explore how the results of these studies could potentially impact clinical guidelines related to that topic.
So now let’s jump into the list of Acute Migraine Treatment Clinical Trials!
Quick View Table of Acute Migraine Clinical Trials
Acute Migraine Treatment Clinical Trials with Results Posted:
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
Guideline Central Link | Full Trial Link
Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
Interventions: DRUG: Dihydroergotamine
Primary Outcomes Measures: Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population), The subject’s rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0)., At Month 12 of Study Medication Dosing|Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population), Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack., At Month 12 of Study Drug Administration
Sponsor: Satsuma Pharmaceuticals, Inc.
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
Guideline Central Link | Full Trial Link
Study STS101-007 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
Interventions: DRUG: Dihydroergotamine; DRUG: Placebo
Primary Outcomes Measures: Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose, The subject’s rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0)., 2 Hours Post-Dose|Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose, Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack., 2 Hours Post-Dose
Sponsor: Satsuma Pharmaceuticals, Inc.
Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
Guideline Central Link | Full Trial Link
The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine.
Interventions: DRUG: Zavegepant (BHV-3500)
Primary Outcomes Measures: Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation, An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes., From study drug dosing up to the end of the study (up to 52 weeks)|Number Of Participants With Clinically Significant Laboratory Abnormalities, Clinically significant laboratory abnormalities were defined as Grades 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome. Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, low-density lipoprotein (LDL)-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in to be included for a given parameter. Laboratory results were presented in US units., From study drug dosing up to the end of the study (up to 52 weeks)
Sponsor: Pfizer
Randomized Trial in Adult Participants With Acute Migraines
Guideline Central Link | Full Trial Link
The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or severe migraine.
Interventions: DRUG: Zavegepant (BHV-3500)
Primary Outcomes Measures: Percentage of Participants With Freedom From Pain at 2 Hours Post-dose, Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose., 2 hours post-dose|Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose, MBS was reported as nausea, photophobia, or phonophobia immediately before dosing using the eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack onset that was absent post-dose., 2 hours post-dose
Sponsor: Pfizer
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
Guideline Central Link | Full Trial Link
MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.
Interventions: DRUG: AXS-07
Primary Outcomes Measures: Long-term Safety of Chronic Intermittent Use of AXS-07, Long-term safety as measured by: Subjects with any TEAEs; Subjects with suspected to be drug-related TEAEs; Subjects with serious TEAEs; Subjects with TEAEs that led to drug withdrawal; Subjects with TEAEs that led to withdrawal from study; Subjects with TEAEs that resulted in death, Up to 12 months
Sponsor: Axsome Therapeutics, Inc.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
Guideline Central Link | Full Trial Link
Study STS101-002 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine
Interventions: DRUG: Dihydroergotamine; DRUG: Placebos
Primary Outcomes Measures: Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose, The subject’s rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0)., 2 Hours Post-Dose|Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose, Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack., 2 Hours Post-Dose
Sponsor: Satsuma Pharmaceuticals, Inc.
Acute Migraine Treatment Clinical Trials without Posted Results
Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)
Guideline Central Link | Full Trial Link
This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.
Interventions: DRUG: AXS-07 (meloxicam-rizatriptan)
Primary Outcomes Measures: Percentage of subjects with headache pain relief, Absence of headache pain and without the use of rescue medication., Hour 2 following dose administration|Percentage of subjects with absence of the Most Bothersome Symptom, Absence of the most bothersome symptom, defined at the onset of migraine., Hour 2 following dose administration
Sponsor: Axsome Therapeutics, Inc.
Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines
Guideline Central Link | Full Trial Link
This investigation describes a proposed clinical trial that will evaluate the relative efficacy of intravenous magnesium sulfate for the treatment of migraine compared to intravenous metoclopramide (Reglan) and intravenous prochlorperazine (Compazine) in the treatment of acute headache and migraine in adult patients.
Interventions: DRUG: Magnesium Sulfate; DRUG: Metoclopramide; DRUG: Prochlorperazine (Compazine) Injection
Primary Outcomes Measures: 30min pain score, 11 point Numerical Rating Scale pain score at 30 minutes after initiation of drug, 30 minutes after initiation
Sponsor: Advocate Health Care
Initiating Early Control of Migraine Pain and Associated Symptoms
Guideline Central Link | Full Trial Link
A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
Interventions: DRUG: AXS-07 (MoSEIC meloxicam and rizatriptan); DRUG: Placebo
Primary Outcomes Measures: Percentage of subjects reporting headache pain freedom, Absence of headache pain, Hour 2|Percentage of subjects with absence of Most Bothersome Symptom, Absence of Most Bothersome Symptom, defined at the onset of migraine, Hour 2
Sponsor: Axsome Therapeutics, Inc.
Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea
Guideline Central Link | Full Trial Link
This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine.
Interventions: DRUG: Naltrexone and Acetaminophen Combination; DRUG: Sumatriptan; DRUG: Placebo
Primary Outcomes Measures: The proportion of patients having no headache pain at 2 hours., Measured by asking the patients to self-report the current status of their headache pain on a four-point Likert scale (i.e., 0=none, 1=mild, 2=moderate, 3=severe)., 2 hours|The proportion of patients having the absence of the most bothersome migraine-associated symptom at 2 hours., The most bothersome migraine-associated symptom is prospectively identified at baseline. It is measured by asking the patients to self-report the current status of their associated symptom as present or absent., 2 hours
Sponsor: Allodynic Therapeutics, Inc
Potential Migraine Guidelines That May Be Affected Include
There you have it – a list of Phase 3 Clinical Trials for Acute Migraine Treatments as of May 2024. Stay tuned, as Part II focused on Migraine Prevention Clinical Trials will be published in the coming days.
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