Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

NCT05503082 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 2020-02
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (2)

• Pain freedom

  Pain freedom at 2 hours.

  2 hours post treatment

• Freedom from most bothersome symptom

  Freedom from most bothersome symptom at 2 hours.

  2 hours post treatment

Secondary Outcomes (6)

• Pain relief at 2 hours

  2 hours post treatment

• Percentage of patients with sustained pain relief from 2-24 hours after initial dose.

  2-24 hours after initial dose

• Percentage of patients with sustained pain freedom from 2-24 hours after initial dose.

  2-24 hours after initial dose

• Pain relief at 2 hours after 2nd dose

  2 hours after 2nd dose

• Percentage of patients with sustained pain relief from 2-24 hours after 2nd dose.

  2-24 hours after 2nd dose

Study Arms (2)

w/o CGRPmAb

PLACEBO COMPARATOR

w/o CGRPmAb

Drug: Ubrogepant 50 MG [Ubrelvy]; Drug: Ubrogepant 100 MG [Ubrelvy]

Tx w/ CGRPmAb

ACTIVE COMPARATOR

Tx w/ CGRPmAb

Drug: Ubrogepant 50 MG [Ubrelvy]; Drug: Ubrogepant 100 MG [Ubrelvy]

Interventions

Ubrogepant 50 MG [Ubrelvy] DRUG

Ubrogepant 50 MG \[Ubrelvy\]

Tx w/ CGRPmAb; w/o CGRPmAb

Ubrogepant 100 MG [Ubrelvy] DRUG

Ubrogepant 100 MG \[Ubrelvy\]

Tx w/ CGRPmAb; w/o CGRPmAb

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ages 18 to 75 years, at screening (Visit 1).
• At least a 1-year history of migraine with or without aura.
• History of ≥3 monthly headache days of at least moderate severity.
• Study patient currently on CGRPmAbs must be on treatment \> 1 month at screening.
• By history, the patient's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom

You may not qualify if:

• History of \<3 monthly headache days of at least moderate severity
• Concomitant use of strong CYP3A4 inducers (e.g., phenytoin, barbiturates, rifampin, St. John's Wort)
• Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
• Currently on Botox treatment for CM.
• Concomitant use of gepants as a preventative treatment.
• Current user of illicit drugs, or a history within 1 year prior to screening (visit 1) of drug or alcohol abuse or dependence
• Clinically significant hematologic, endocrine, cardiovascular, pulmonary, gastrointestinal, or neurologic disease. If there is a history of such a disease, but the condition has been stable for more than 1 year prior to screening (visit 1) and is judged by the PI as not likely to interfere with participation in the study, the participant may be included.
• Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating.

Sponsors & Collaborators

• Chicago Headache Center & Research Institute: lead
• AbbVie: collaborator

Study Sites (2)

Chicago Headache Center & Research Institute

Chicago, Illinois, 60657, United States

Location

Chicago Headache Center & Research Institute

Naperville, Illinois, 60563, United States

Location

Related Publications (1)

• Dodick DW, Lipton RB, Ailani J, Halker Singh RB, Shewale AR, Zhao S, Trugman JM, Yu SY, Viswanathan HN. Ubrogepant, an Acute Treatment for Migraine, Improved Patient-Reported Functional Disability and Satisfaction in 2 Single-Attack Phase 3 Randomized Trials, ACHIEVE I and II. Headache. 2020 Apr;60(4):686-700. doi: 10.1111/head.13766. Epub 2020 Feb 19.

  PMID: 32073660 BACKGROUND

Related Links

• Chicago Headache Center \& Research Institute

MeSH Terms

Conditions

Migraine Disorders

Interventions

ubrogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Bradley Torphy, MD

  Chicago Headache Center & Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Director

Model Details: Phase IV prospective open label randomized clinical study evaluating safety and efficacy of ubrogepant (UBRELVY) in patients currently treated with one of the injectable monoclonal antibodies targeting CGRP or the CGRP receptor (Aimovig, Ajovy, or Emgality).

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 16, 2022
• Study Start: September 6, 2022
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)