Ubrogepant for Migraine

(UBRO MM Trial)

Recruiting at 78 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AbbVie

Disqualifiers: Cardiovascular, Cerebrovascular, Medication overuse, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed. Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico. Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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.

What data supports the effectiveness of the drug Ubrogepant for treating migraines?

Research shows that Ubrogepant is effective for treating migraines, as it was tested in several clinical trials where it helped reduce migraine pain and symptoms compared to a placebo (a substance with no active drug). ^{1 2 3 4 5}

Is Ubrogepant safe for humans?

Ubrogepant has been studied for treating migraines, and research shows it is generally safe for short-term use. However, its long-term safety in a large number of people still needs more investigation. ^{1 3 5 6 7}

How is the drug ubrogepant different from other migraine treatments?

Ubrogepant is unique because it is the first oral medication that specifically blocks the calcitonin gene-related peptide (CGRP) receptor, which is a key player in migraine pain. Unlike some other treatments, it is taken as needed for acute migraine attacks and does not cause liver damage at therapeutic doses. ^{1 3 8 9 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Ubrogepant (Anti-migraine agent)

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.

Participant Groups

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.

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

Findings from Research

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 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]

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]

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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. [2021]

2. United States 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. [2022]

3. United States 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. [2021]

4. New Zealand 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Ubrogepant: An Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for Abortive Migraine Treatment. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

Ubrogepant to treat migraine. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Ubrogepant: First Approval. [2020]

10. England 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. [2023]