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NCT05503082 · ClinicalTrials.gov registry record · Phase 4
Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies
A Phase 4 study of Headache, Migraine, sponsored by Chicago Headache Center & Research Institute.
- Active
- Registry status
- Phase 4
- Development phase
- 164
- Enrollment target
- 2
- Study locations
NCT05503082 is a Phase 4 study of Headache, Migraine that is active but no longer recruiting, run by Chicago Headache Center & Research Institute. The registered enrollment target is 164 participants, below the 230-participant average among 7 other Headache, Migraine trials with a reported enrollment target (29% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05503082, a Phase 4 study of Headache, Migraine, is active but no longer recruiting, sponsored by Chicago Headache Center & Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 164 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DRUG Ubrogepant 50 MG [Ubrelvy]
- DRUG Ubrogepant 100 MG [Ubrelvy]
Study Locations (2)
Illinois
- Chicago Headache Center & Research Institute - Chicago
- Chicago Headache Center & Research Institute - Naperville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2024-11 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05503082
The ClinicalTrials.gov registry entry for NCT05503082 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 7 other Headache, Migraine trials with a reported enrollment target (29% lower). The listed sponsor is Chicago Headache Center & Research Institute, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Headache, Migraine appearing as the primary indexed condition, and to 2 interventions - of which Ubrogepant 50 MG [Ubrelvy] is the first listed.
NCT05503082 reports 2 study locations spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05503082 about?
NCT05503082 is a clinical study titled "Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies". 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 migrain...
What is the current status of trial NCT05503082?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 164 participants. The study started on 2022-09-06. Estimated completion is 2024-11.
What conditions does trial NCT05503082 study?
This clinical trial studies the following conditions: Headache, Migraine.
What interventions are being tested in trial NCT05503082?
The interventions under investigation include: Ubrogepant 50 MG [Ubrelvy] (DRUG), Ubrogepant 100 MG [Ubrelvy] (DRUG).
Who is sponsoring clinical trial NCT05503082?
This trial is sponsored by Chicago Headache Center & Research Institute, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05503082 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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