A Study to Learn About Zavegepant as a Treatment for Multiple Migraine Attacks in Adult Participants

Pfizer

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Migraine

Treatments: Combination Product: Placebo - Control 2; Combination Product: Placebo - Control 1; Combination Product: Zavegepant 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06103734

2023-505209-17-00 (Registry Identifier)

C5301007

Details and patient eligibility

About

The purpose of this study to show that zavegepant 10 milligrams given through the nose provides:

• freedom from pain, 2 hours after taking the medicine for the first migraine attack.
• consistent freedom from pain, 2 hours after taking the medicine across 4 separate migraine attacks.

This study is seeking participants who:

• are 18 years of age or older.
• have migraine attacks present for at least 1 year with age onset before 50 years old.
• have migraine attacks, on average, lasting about 4 to 72 hours if not treated.
• have 3 to 8 attacks per month but less than15 headache days per month.

If the participant is fit to take part in the study, the participant will receive either the study medicine zavegepant or placebo. A placebo looks like zavegepant but does not contain active ingredients. The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo.

The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity. The participants are expected to treat up to 4 migraines of moderate to severe intensity.

After taking the study medicine, the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo. Participant can take other medicines after the 2 hours if the migraine is still present. The participant is expected to record on a paper log all medications taken throughout the study.

The study duration is around 26 weeks. This includes a 28-day screening window, up to 20 weeks of treatment period, and a follow up visit at about 4 weeks after taking the study medicine the last time.

The participant is expected to come into the study center up to 4 times. There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first, at Month 3 if the participant is still in the study, and a safety follow-up.

During the study, the participant is expected to complete two sets of questions in an app on a smartphone. This step is done before and after taking the study medicine. The participants must rate:

• Pain
• Pain symptoms
• How the participants are feeling
• General well-being

Enrollment: 1,280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants aged 18 years or older.
2. Participants with minimum 1 year history of migraine with age onset before 50 years of age.

Exclusion criteria

1. History of retinal migraine, basilar migraine or hemiplegic migraine.

2. History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease.

3. Major depressive disorder or anxiety disorder.

4. Acute or chronic pain syndromes.

5. Conditions that may affect the administration or absorption of the nasal product.

6. History of alcohol abuse and/or illicit drug.

7. Other social, medical, or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

8. Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s)

9. History of use of ergotamine medications or triptans on greater than/equal to 10 days per month on a regular basis for greater than/equal to 3 months. Or history of non-narcotic analgesic intake on greater than/equal to 15 days per month for greater than/equal to 3 months for other pain indications.

10. Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days prior to Baseline Visit.

    Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.

11. Previous participation in any zavegepant study within the last 2 years.

12. ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:

    1. Class 2 or Class 3 obesity, defined as body mass index >35 kg/m2.
    2. Estimated Globular Filtration Rate <30 mL/min/1.73 m2.
    3. Total bilirubin ≥1.5 × upper limit of normal.
    4. Liver transaminases ≥2.0 × upper limit of normal .
    5. Neutrophil count ≤1000/μL (or equivalent).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,280 participants in 3 patient groups, including a placebo group

Zavegepant 10 mg

Active Comparator group

Description:

This is the active arm where the participant will receive 4 doses of the zavegepant 10mg intranasal

Treatment:

Combination Product: Zavegepant 10 mg

Placebo - Control 1

Placebo Comparator group

Description:

This is one of the two placebo arms where the participant will receive 3 doses of placebo and 1 dose of zavegepant 10mg intranasal. Participant will not know which dose will be zavegepant.

Treatment:

Combination Product: Placebo - Control 1

Placebo - Control 2

Placebo Comparator group

Description:

This is one of the two placebo arms where the participant will receive 3 doses of placebo and 1 dose of zavegepant 10mg intranasal. Participant will not know which dose will be zavegepant.

Treatment:

Combination Product: Placebo - Control 2