Today we’re going to cover the second 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).
The focus of Part 1 was Acute Migraine Treatment of Adults. In Part 2, our focus will shift to Migraine Prevention in 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 series is intended to provide a preview of what new innovations are to come on a given topic, and how might the results of those studies ultimately impact clinical guidelines on the topic(s).
So now let’s jump into the list of Migraine Prevention Clinical Trials!
Quick View Table of Migraine Prevention Clinical Trials
Migraine Prevention Clinical Trials Without Results Posted:
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
- Sponsor: AbbVie
- This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine
- Interventions: DRUG: Atogepant
- Primary Outcomes Measures: Percentage of Participants with at Least 1 Treatment Emergent Adverse Event, 156 weeks
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults
- Sponsor: Ipsen
- The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing chronic migraine.
- Interventions: BIOLOGICAL: Botulinum toxin type A; DRUG: Placebo
- Primary Outcomes Measures: Change from baseline in monthly migraine days (MMD), The monthly migraine days (MMD) is assessed by eDiary, completed every day by the participant, to evaluate the efficacy of Dysport® compared to placebo., Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults
- Sponsor: Ipsen
- The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing episodic migraine.
- Interventions: BIOLOGICAL: Botulinum toxin type A
- Primary Outcomes Measures: Change from baseline in monthly migraine days (MMD), The monthly migraine days (MMD) is assessed by a daily eDiary, completed by the participant, to evaluate the efficacy of Dysport® compared to placebo., Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
- Sponsor: Pfizer
- The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.
- Interventions: DRUG: BHV-3500 (zavegepant); DRUG: Placebo
- Primary Outcomes Measures: Efficacy of zavegepant compared to placebo as a preventive treatment for migraine, Measured by the mean reduction from baseline (i.e., Observation Phase) in the number of migraine days per month over the entire Double-blind Treatment Phase., Number of migraine during weeks 1 to 12
Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
- Sponsor: AbbVie
- The study will assess safety and tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored.
- Interventions: DRUG: Atogepant
- Primary Outcomes Measures: Number of Participants With Adverse Events (AEs), An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above., Up to approximately 28 Weeks|Responder Status of at least 25% Reduction in the Frequency of Monthly Migraine Days Collected via Daily Electronic Diary (eDiary), Percentage of participants achieving at least 25% reduction from baseline in the frequency of monthly migraine days will be assessed., Baseline (Week 0) through 24 Weeks|Responder Status of at least 30% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary, Percentage of participants achieving at least 30% reduction from baseline in the frequency of monthly migraine days will be assessed., Baseline (Week 0) through 24 Weeks|Responder Status of at least 50% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary, Percentage of participants achieving at least 50% reduction from baseline in the frequency of monthly migraine days will be assessed., Baseline (Week 0) through 24 Weeks|Responder Status of at least 75% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary, Percentage of participants achieving at least 75% reduction from baseline in the frequency of monthly migraine days will be assessed., Baseline (Week 0) through 24 Weeks|Responder Status of at least 100% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary, Percentage of participants achieving at least 100% reduction from baseline in the frequency of monthly migraine days will be assessed., Baseline (Week 0) through 24 Weeks|Change From Baseline in Monthly Migraine Days, Change from Baseline in monthly migraine days, defined by International Headache Society (IHS) Guidelines 2018 will be assessed., Baseline (Week 0) through 24 Weeks|Change from Baseline in Monthly Headache Days, Moderate or Severe Headache Days, Cumulative Hours of Headache, Acute Treatment Medication Use Days, Headache Free Days, and Migraine Symptom-Free Days, Change from baseline in monthly headache days, moderate or severe headache days, cumulative hours of headache, acute treatment medication use days, headache free days, and migraine symptom-free days, defined by IHS Guidelines 2018 will be assessed., Baseline (Week 0) through 24 Weeks|Change from Baseline in Monthly days with Non-Headache Migraine Symptoms, Change from baseline in monthly days with non-headache migraine symptoms such as photophobia, phonophobia, nausea and/or vomiting, dizziness, neck pain, tiredness, mood change, yawning, thirst, cravings, urinary frequency, cranial autonomic symptoms, Baseline (Week 0) through 24 Weeks|Change from Baseline in Monthly Activity Impairment in Migraine – Diary (AIM-D), The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items)., Baseline (Week 0) through 24 Weeks
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)
- Sponsor: Click Therapeutics, Inc.
- Randomized study of two digital therapeutics for the prevention of episodic migraine in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
- Interventions: DEVICE: Click Digital Therapeutic
- Primary Outcomes Measures: Change in Monthly Migraine Days (MMDs), Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12, Baseline to Week 12
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine
- Sponsor: Click Therapeutics, Inc.
- Randomized study of two digital therapeutics for the prevention of episodic migraine
- Interventions: DEVICE: ReMMi-D Digital Therapeutic
- Primary Outcomes Measures: Change in MMD (monthly migraine days), Change from baseline in the number of Monthly Migraine Days (MMD) at Week 12 of intervention, Baseline to Week 12
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
- Sponsor: AbbVie
- This study will assess the effects of BOTOX in preventing migraine in adult participants with EM.
- Interventions: DRUG: BOTOX; DRUG: Placebo
- Primary Outcomes Measures: Change From Baseline in the Frequency of Monthly Migraine Days, Change from baseline in the frequency of monthly migraine days (i.e., migraine or probable migraine headache days) will be assessed., 6 Months
Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine
- Sponsor: Tian Medical Inc.
- This is a double blind placebo-controlled study which will evaluate the efficacy of bupivacaine compared to saline, delivered by the Tx360® device to the sphenopalatine ganglion (SPG), to treat chronic migraine headache.
- Interventions: DEVICE: Tx360
- Primary Outcomes Measures: Change in Number of Migraine Headaches During Treatment Phase, Evaluate the efficacy of bupivacaine delivered with the Tx360® device, based on the change in the number of migraine days during treatment., From 28-day screening/baseline phase to the end of the 4-week treatment phase.
BOTOX® vs. XEOMIN® for Chronic Migraine
- Sponsor: Naval Medical Center Camp Lejeune
- In this study, we will test the efficacy of incobotulinumtoxinA, a neurotoxin that, unlike onabotulinumtoxinA, does not require refrigeration, but is an effective off-label alternative for the treatment of migraine.
- Interventions: DRUG: IncobotulinumtoxinA (XEOMIN®); DRUG: OnabotulinumtoxinA (BOTOX®)
- Primary Outcomes Measures: Headache days per month, To compare the difference in headache days per month (incobotulinumtoxinA (XEOMIN®) relative to onabotulinumtoxinA (BOTOX®)) at the end of treatment period (24 weeks)., 24 weeks + Baseline
Acute Migraine Treatment Clinical Trials With Posted Results
Efficacy, Tolerability, and Safety of DFN-15
- Sponsor: BioDelivery Sciences International
- Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States
- Interventions: DRUG: DFN-15; DRUG: Placebo
- Primary Outcomes Measures: Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (First Treated Double-blind Treatment Period), The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\], 2 hours postdose|Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose, Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period), 2 hours postdose
Efficacy, Tolerability, and Safety Study of DFN-15
- Sponsor: BioDelivery Sciences International
- Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States.
- Interventions: DRUG: DFN-15; DRUG: Placebo
- Primary Outcomes Measures: Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1), Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]) during DB1., 2 hours post dose|Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1), Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1., 2 hours post dose
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
- Sponsor: H. Lundbeck A/S
- Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.
- Interventions: DRUG: Eptinezumab; DRUG: Placebo
- Primary Outcomes Measures: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12, A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ‰¥4 hours, had ‰¥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ‰¥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ‰¥30 minutes and the participant had an aura with the headache. Criterion C: lasted ‰¥30 minutes and met ‰¥2 of the following criteria: lasted ‰¥4 hours, had ‰¥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ‰¥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine., Baseline, Weeks 1 – 12
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
- Sponsor: Allergan
- This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.
- Interventions: DRUG: Atogepant; DRUG: Placebo
- Primary Outcomes Measures: Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population, Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis., Baseline to Week 12|Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population, Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis., Baseline to Week 12
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
- Sponsor: AbbVie
- Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
- Interventions: DRUG: Ubrogepant; DRUG: Placebo
- Primary Outcomes Measures: Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose, The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use., 24 hours after taking double-blind study intervention during the prodrome
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
- Sponsor: Allergan
- This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.
- Interventions: DRUG: Atogepant; DRUG: Placebo
- Primary Outcomes Measures: Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population, Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period., Baseline to Week 12|Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population, Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period., Baseline to Week 12
Potential Migraine Guidelines That May Be Affected Include
There you have it – a list of Phase 3 Clinical Trials for Migraine Prevention as of May 2024. Sign up for alerts and stay informed on the latest published guidelines and our Guidelines+ Clinical Trials series.