A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Part of paid clinical trials in Orlando, Florida.

Sponsor
H. Lundbeck A/S
Study ID
NCT06578585
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ubrogepant — DRUG
    Tablet
  • Lu AG09222 — DRUG
    Solution for injection/infusion
  • Placebo — DRUG
    Solution for injection/infusion

Study Details

The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Key Dates

Start date
Sep 13, 2024
Status verified
Oct 2025
Primary completion
Jul 11, 2025
Completion
Jul 11, 2025

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ubrogepant with Lu AG09222
    Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.
  • Placebo Comparator: Ubrogepant with Placebo
    Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant.

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 92 Days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Neuroscience SolutionsOrlandoFlorida32801-
NeuroTrials ResearchAtlantaGeorgia30328-
Future Search TrialsAustinTexas78731-
Elevate Clinical ResearchSeabrookTexas77586-

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