450 Participants Needed

Ubrogepant for Migraine

(UBRO MM Trial)

Recruiting at 78 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: AbbVie
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.45678

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).145910

Who Is on the Research Team?

AI

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.
See 3 more

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?
3Treatment groups
Experimental Treatment
Group I: Open-Label Extension Period: UbrogepantExperimental Treatment1 Intervention
Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.
Group II: Double-Blind Period: UbrogepantExperimental Treatment1 Intervention
Participants will receive ubrogepant during the double-blind period.
Group III: Double-Blind Period: Placebo for UbrogepantExperimental Treatment1 Intervention
Participants will receive placebo during the double-blind period.

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Ubrogepant for:
  • Acute treatment of migraine in adults

Find a Clinic Near You

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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

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.
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]
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.
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.
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]

Citations

Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. [2021]
Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. [2022]
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]
Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. [2023]
Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. [2021]
Ubrogepant: An Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for Abortive Migraine Treatment. [2022]
Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. [2023]
Ubrogepant to treat migraine. [2020]
Ubrogepant: First Approval. [2020]
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]
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