A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults

Conditions

• Chronic Migraine
• Episodic Migraine

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• IPN10200 — BIOLOGICAL
  Lyophilised powder
• Placebo — OTHER
  Excipients without active substance, Lyophilised powder
• IPN10200 dose A — BIOLOGICAL
  Lyophilised powder
• IPN10200 dose B — BIOLOGICAL
  Lyophilised powder

Study Details

A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. IPN10200 is a medication that stops the release of these chemical messengers. Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics. This study aims to determine: * The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM, * The right amount (dose) of IPN10200 to inject at each point, * The total amount (dose) of IPN10200 that provides the best balance between safety and efficacy preventing migraines. Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks.

Key Dates

Start date

Oct 10, 2024

Status verified

Apr 2026

Primary completion

Jan 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

641 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Step 1 - Cohort 1- IPN10200
  Participants will receive IPN10200 dose A through injections at Day 1.
• Placebo Comparator: Step 1 - Cohort 1 - Placebo
  Participants will receive placebo through injections at Day 1.
• Experimental: Step 1 - Cohort 2 - IPN10200
  Participants will receive IPN10200 dose B through injections at Day 1.
• Placebo Comparator: Step 1 - Cohort 2 - Placebo
  Participants will receive placebo through injections at Day 1.
• Experimental: Step 2- EM group IPN10200 Dose A
  Dose A will be administered to the participants in a single treatment cycle.
• Experimental: Step 2- EM group IPN10200 Dose B
  Dose B will be administered to the participants in a single treatment cycle
• Placebo Comparator: Step 2- EM group placebo
  Placebo will be administered to the participants in a single treatment cycle
• Experimental: Step 2- CM group IPN10200 Dose A
  Dose A will be administered to the participants in a single treatment cycle
• Experimental: Step 2- CM group IPN10200 Dose B
  Dose B will be administered to the participants in a single treatment cycle
• Placebo Comparator: Step 2- CM group placebo
  Placebo will be administered to the participants in a single treatment cycle

Primary Outcome Measure

Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuation [ Time Frame: For step 1: From baseline until end of study at Week 36 ]

Central Contacts

• Ipsen Clinical Study Enquiries
  See e mail
  [email protected]

Locations (71)

Find similar trials in Birmingham, AL

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