898 Participants Needed

Lu AG09222 for Migraine

(PROCEED Trial)

Recruiting at 117 trial locations
Ec
Overseen ByEmail contact via H. Lundbeck A/S
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.

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 might be best to discuss this with the trial coordinators.

How does the drug Lu AG09222 differ from other migraine treatments?

Lu AG09222 is unique because it targets the GLU(K5) kainate receptor, which is involved in the pain pathways of migraines. This mechanism is different from traditional migraine treatments like triptans, which target serotonin receptors. By focusing on glutamate receptors, Lu AG09222 offers a novel approach to managing migraines.12345

Eligibility Criteria

This trial is for adults who have suffered from migraines for over a year, get them at least 4 days each month, and haven't found relief with 2-4 other preventive medications. They must have been diagnosed according to specific guidelines and had their first migraine before turning 51.

Inclusion Criteria

I have had 4 or more migraine days each month for the last 3 months.
I have been diagnosed with migraine according to ICHD-3 guidelines.
I have tried 2-4 migraine preventives in the last 10 years without success.
See 2 more

Exclusion Criteria

I have a history of severe headaches.
I have been diagnosed with an active jaw joint disorder.
I have been treated with anti-PACAP before.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of Lu AG09222 or placebo to determine the effective dose for migraine prevention

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Lu AG09222
Trial OverviewThe study is testing different doses of a new medication called Lu AG09222 against a placebo to see which dose might prevent migraines in people who didn't respond well to previous treatments. Participants will be randomly assigned to receive either the drug or placebo.
Participant Groups
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I: Lu AG09222 IVExperimental Treatment1 Intervention
Participants will receive Lu AG09222 by IV infusion.
Group II: Group H: Lu AG09222 IVExperimental Treatment1 Intervention
Participants will receive Lu AG09222 by IV infusion.
Group III: Group G: Lu AG09222 IVExperimental Treatment1 Intervention
Participants will receive Lu AG09222 by IV infusion.
Group IV: Group E: Lu AG09222 SC (closed for recruitment)Experimental Treatment1 Intervention
Participants will receive 2 injections, each containing Lu AG09222.
Group V: Group D: Lu AG09222 SC (closed for recruitment)Experimental Treatment2 Interventions
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group VI: Group C: Lu AG09222 SC (closed for recruitment)Experimental Treatment2 Interventions
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group VII: Group B: Lu AG09222 SC (closed for recruitment)Experimental Treatment2 Interventions
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group VIII: Group A: Placebo SC (closed for recruitment)Placebo Group1 Intervention
Participants will receive 2 injections of placebo.
Group IX: Group F: Placebo IVPlacebo Group1 Intervention
Participants will receive placebo by intravenous (IV) infusion.

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lundbeck A/S

Lead Sponsor

Trials
332
Recruited
78,300+
Charl van Zyl profile image

Charl van Zyl

H. Lundbeck A/S

Chief Executive Officer since 2023

Degree in Medical Biochemistry from the University of Cape Town, South Africa

Johan Luthman profile image

Johan Luthman

H. Lundbeck A/S

Chief Medical Officer since 2019

MD from the University of Gothenburg, Sweden

Findings from Research

LY466195 is a highly potent selective antagonist of the GLU(K5) kainate receptor, showing strong efficacy in reducing migraine-related responses in animal models, with effective doses as low as 1 microg/kg.
The compound demonstrated safety in vitro, showing no contractile activity in rabbit veins and no significant behavioral side effects at high oral doses, suggesting a favorable safety profile for potential therapeutic use.
Pharmacological characterization of the competitive GLUK5 receptor antagonist decahydroisoquinoline LY466195 in vitro and in vivo.Weiss, B., Alt, A., Ogden, AM., et al.[2014]
In a trial involving 45 patients, LY293558, an AMPA/KA receptor antagonist, showed a 69% headache response rate, significantly better than placebo (25%) and comparable to sumatriptan (86%), indicating its potential efficacy in treating acute migraines.
While 15% of patients experienced adverse events with LY293558, this was lower than the 53% for sumatriptan, suggesting a favorable safety profile for LY293558 that warrants further investigation in larger studies.
LY293558, a novel AMPA/GluR5 antagonist, is efficacious and well-tolerated in acute migraine.Sang, CN., Ramadan, NM., Wallihan, RG., et al.[2012]
In a study involving two Phase 3 trials with patients experiencing migraines, a second dose of lasmiditan showed some effectiveness for treating headache recurrence, with 50% of patients pain-free compared to 32% with placebo.
However, there was no significant benefit of a second dose for rescue treatment, and the safety profile was similar for lasmiditan and placebo, indicating that the second dose did not increase the risk of adverse events.
Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN).Loo, LS., Plato, BM., Turner, IM., et al.[2020]

References

Pharmacological characterization of the competitive GLUK5 receptor antagonist decahydroisoquinoline LY466195 in vitro and in vivo. [2014]
LY293558, a novel AMPA/GluR5 antagonist, is efficacious and well-tolerated in acute migraine. [2012]
Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN). [2020]
[Migraine therapy]. [2018]
Pharmacological aspects of experimental headache models in relation to acute antimigraine therapy. [2019]