Ubrogepant for Migraine

(UBRO MM Trial)

Recruiting at 78 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Cardiovascular, Cerebrovascular, Medication overuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

496 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of ubrogepant for treating menstrual migraines, which are severe headaches linked to menstrual cycles. Ubrogepant is a new drug under study for the short-term prevention of these migraines. Participants will be divided into two groups to receive either ubrogepant or a placebo (a non-active pill) for comparison. Women who have experienced migraines during at least two out of three recent menstrual cycles and have regular periods may qualify for this trial. Participants will track symptoms daily and attend regular clinic visits. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that ubrogepant is generally safe for most users. In a study on its long-term safety, 813 participants took ubrogepant for a year, receiving a total of 31,968 doses. This indicates that many can use ubrogepant without serious issues. The most common side effects were mild, including nausea, drowsiness, and dry mouth. These side effects were minor compared to the treatment's benefits. Overall, evidence suggests that ubrogepant is safe for many when used as directed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Ubrogepant is unique because it belongs to a class of medications known as CGRP receptor antagonists, which target and block the receptor for calcitonin gene-related peptide (CGRP) involved in migraine attacks. Unlike many traditional migraine treatments that often rely on vasoconstriction, such as triptans, ubrogepant offers a non-vasoconstrictive option, making it a safer choice for individuals with cardiovascular concerns. Additionally, ubrogepant is taken orally, providing an easy and convenient method for managing migraines as they occur. Researchers are excited about ubrogepant because it has the potential to offer relief without the cardiovascular risks associated with some existing treatments.

What evidence suggests that ubrogepant might be an effective treatment for menstrual migraine?

Research has shown that ubrogepant, which participants in this trial may receive, effectively treats migraines, including those associated with menstrual cycles. Studies indicate that ubrogepant can help individuals become pain-free within two hours of taking it. One study found that those who took ubrogepant at the first sign of a migraine could return to normal activities within 24 hours. Over 90% of users reported they would continue using ubrogepant, highlighting its effectiveness and user satisfaction. Ubrogepant is considered a safe and well-tolerated option for migraine relief. ^{3 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adult females with a history of migraine, specifically menstrual migraine. Participants should have regular menstrual cycles and experience migraines during their period in at least two out of three cycles. They must be able to record daily diary data and have had less than 15 headache days per month.

Inclusion Criteria

I have had migraine attacks during my period in at least 2 of the last 3 cycles.

I have had migraines for at least a year.

I have tracked my migraines related to my menstrual cycle for 3 cycles.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive oral ubrogepant or placebo once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs

16 weeks

Regular visits at a hospital or clinic

Open-Label Extension

Eligible participants continue to receive oral ubrogepant once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses

52 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ubrogepant

Trial Overview The study tests Ubrogepant's safety and effectiveness against placebo in preventing menstrual migraines. Around 450 women will take oral ubrogepant or placebo starting three days before their estimated menses for seven days, over three menstrual periods in the initial phase.

How Is the Trial Designed?

Group I: Open-Label Extension Period: Ubrogepant Experimental Treatment 1 Intervention

Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.

Group II: Double-Blind Period: Ubrogepant Experimental Treatment 1 Intervention

Participants will receive ubrogepant during the double-blind period.

Group III: Double-Blind Period: Placebo for Ubrogepant Experimental Treatment 1 Intervention

Participants will receive placebo during the double-blind period.

Ubrogepant is already approved in United States for the following indications:

Approved in United States as Ubrogepant for:

• Acute treatment of migraine in adults

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a pooled analysis of 2240 participants from two phase 3 trials, ubrogepant 50 mg demonstrated significant efficacy in achieving pain freedom at 2 hours post-dose, with 20.5% of participants reporting this compared to 13.0% in the placebo group (P < 0.001).

Ubrogepant also showed a favorable safety profile, with similar rates of adverse events (11.5% for placebo vs. 11.2% for ubrogepant), and no serious adverse events related to treatment were reported, indicating it is a well-tolerated option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. Hutchinson, S., Dodick, DW., Treppendahl, C., et al.[2023]

A comprehensive analysis of 2,067 reports from the FDA Adverse Event Reporting System revealed that Ubrogepant, used for treating acute migraines, is associated with various adverse events, including nausea, dizziness, and new reports of hemiparesis and mental impairment.

The study highlights the importance of monitoring Ubrogepant's long-term safety, as it identified new adverse events not previously documented in clinical trials, enhancing our understanding of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. Cao, B., Gu, S., Shen, Z., et al.[2023]

Ubrogepant significantly improves pain freedom and reduces bothersome migraine symptoms within 2 hours compared to placebo, with 20.8% of patients achieving pain freedom versus 12.6% for placebo in a meta-analysis of three trials involving 3326 patients.

Short-term use of ubrogepant does not increase the risk of treatment-related adverse events compared to placebo, indicating it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. Yang, Y., Chen, M., Sun, Y., et al.[2021]

Ubrogepant, a calcitonin gene-related peptide receptor antagonist, has been shown to be significantly more effective than placebo in providing relief from migraine pain within 2 hours, with odds ratios indicating strong efficacy at both 50 mg and 100 mg doses.

This medication is a safe and effective alternative for patients who cannot tolerate traditional migraine treatments like NSAIDs or triptans, making it an important option for those with limited treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant: An Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for Abortive Migraine Treatment. Nedd, M., Garland, S., Falk, N., et al.[2022]

In a 52-week trial involving 1230 participants, ubrogepant (50 mg and 100 mg) was found to be safe and well-tolerated for the acute treatment of migraines, with low rates of treatment-related adverse events (10% for 50 mg and 11% for 100 mg).

The most common side effect was upper respiratory tract infection, and there were no serious liver-related issues, indicating that ubrogepant does not significantly impact liver function, which is crucial for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. Ailani, J., Lipton, RB., Hutchinson, S., et al.[2021]

In a pooled analysis of 2,247 participants from the ACHIEVE I and II trials, ubrogepant demonstrated similar efficacy in treating acute migraine regardless of whether participants were using preventive medications, indicating it is effective for both groups.

The safety profile of ubrogepant was also consistent, with no significant differences in treatment-emergent adverse events between those on preventive treatments and those not, suggesting it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Blumenfeld, AM., Knievel, K., Manack Adams, A., et al.[2022]

In a Phase 3 clinical trial involving 1686 participants, ubrogepant demonstrated significantly greater efficacy than placebo for acute migraine treatment, with 21.8% of patients achieving pain freedom at 2 hours after taking the 50 mg dose.

Ubrogepant 50 mg also resulted in a higher rate of absence of the most bothersome migraine-associated symptom compared to placebo, indicating its potential effectiveness in alleviating multiple aspects of migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. Lipton, RB., Dodick, DW., Ailani, J., et al.[2021]

In a phase 3 trial involving 518 participants, ubrogepant 100 mg significantly reduced the occurrence of moderate or severe headaches when taken during the prodrome phase of a migraine, with 46% of treated events showing improvement compared to 29% with placebo (p<0.0001).

Ubrogepant was found to be well tolerated, with a slightly higher incidence of adverse events (17%) compared to placebo (12%), indicating it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Dodick, DW., Goadsby, PJ., Schwedt, TJ., et al.[2023]

Ubrogepant is the first oral CGRP receptor antagonist approved by the FDA for the acute treatment of migraine, showing effectiveness in alleviating pain and associated symptoms like nausea and sensitivity to light and sound.

In pivotal phase III trials, ubrogepant demonstrated a good safety profile without hepatotoxicity at therapeutic doses, with some patients achieving full pain relief after just one dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant to treat migraine. Dhir, A.[2020]

Ubrogepant (Ubrelvy™) is a highly-selective CGRP antagonist that was approved in December 2019 for the acute treatment of migraines in adults, marking a significant advancement in migraine therapy.

As an orally administered medication, ubrogepant offers a new option for adults suffering from migraines, providing a targeted mechanism of action that specifically blocks the CGRP pathway involved in migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant: First Approval. Scott, LJ.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8140011/

Ubrogepant for the Acute Treatment of Migraine: Pooled ... These results further support ubrogepant as a well-tolerated, safe, and effective acute treatment of migraine with or without aura in adults.

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000209745

Effect of Ubrogepant on Patient-Reported Outcomes When ... This study provides Class II evidence that taking ubrogepant 100 mg during a migraine prodrome allows more patients to function normally over the next 24 hours.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1813049

Ubrogepant for the Treatment of Migraine The coprimary efficacy end points were freedom from pain at 2 hours after the initial dose of ubrogepant or placebo and absence of the most ...

4. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/full/10.1111/head.14839

Ubrogepant users' real‐world experience: Patients on ... More than 90% of participants indicated they were likely to continue using ubrogepant as an acute medication for migraine. Taken together, these ...

5. ubrelvyhcp.com ubrelvyhcp.com/results

UBRELVY® Results & Efficacy Data Ubrogepant, an acute treatment for migraine, improved patient-reported functional disability and satisfaction in 2 single-attack phase 3 randomized trials, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693258/

A Comprehensive Review of the Mechanism, Efficacy, Safety ... The higher rates observed with ubrogepant were relatively small, suggesting that the drug is generally well-tolerated [40]. Table 4. Comparison ...

7. ubrelvyhcp.com ubrelvyhcp.com/safety

Safety & Side Effects | UBRELVY® (ubrogepant) HCP LONG-TERM SAFETY ESTABLISHED. The long-term safety of UBRELVY was further established in 813 patients in a 52-week, open-label trial with 31,968 doses given ( ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/211765s000lbl.pdf

UBRELVY (ubrogepant) - accessdata.fda.gov The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established. 2.2 Dosage ...

9. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14871

Safety and tolerability of ubrogepant for the acute treatment of ... The combination of atogepant and ubrogepant was shown to be well tolerated and without clinically meaningful drug interactions in a ...