Health Trials

Study of EVO756 in Adults With Migraine

ConditionMigraine
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorEvommune, Inc.

About this trial

This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to <65 years

Migraine with or without aura, per ICHD-3 criteria

History of failure with prior preventive migraine treatments

Not currently using migraine preventive therapy

Disqualifiers

Difficulty distinguishing migraine from other headache types or presence of other primary headache disorders

Use of certain medications

Any clinically significant medical, psychiatric, neurological, cardiovascular, or laboratory abnormalities

Trial design

Design model

Parallel

Treatments tested in this trial

  • EVO756, Dose 1

    Drug

    Orally administered EVO756, Dose 1 (Daily)

  • EVO756, Dose 2

    Drug

    Orally administered EVO756, Dose 2 (Daily)

  • Placebo

    Drug

    Placebo Control (Daily)

Treatment groups

330 Participants
are divided into 3 treatment groups
Group A: Dose 1Experimental treatment 1 intervention
Group B: Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change from baseline in the number of monthly migraine days (MMD)

Time frame
Last month of the 12-week treatment period

Secondary outcomes

1

Mean change from baseline in the number of MMD

Time frame
Weeks 4, 8, and across the treatment period (up to 12-weeks)
2

Mean change from baseline in the number of monthly headache days (MHD)

Time frame
Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
3

Proportion of subjects achieving ≥50% and ≥75% reduction in MMD

Time frame
Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
4

Proportion of subjects achieving ≥50% and ≥75% reduction in MHD

Time frame
Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evommune, Inc.

Lead sponsor

Source ClinicalTrials.gov
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