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.
The study will consist of 3 periods: 1. A 'screening period' to assess whether the participant can take part in the study. 2. Step 1 is divided in two cohorts. The study will assess sequentially the safety of two doses of IPN10200, a lower dose in the cohort 1 and a higher dose in cohort 2. Participants will be administered with the study drug or placebo. The treatment is injected in muscles of the head, face and neck. The safety of participants is monitored throughout the 36 weeks at each cohort. 3. Step 2: In this step, new eligible participants will be divided into two groups based on their diagnosis (EM or CM). These groups will then be randomly assigned to one of three intervention groups: Dose A, Dose B, or a placebo. The intervention will be given in a series of injections in muscles of the head, face and neck. Participants will be monitored for both efficacy and safety until they complete the Week 36 visit (the end of study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
641
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Central Research Associates
Birmingham, Alabama, United States
NOT_YET_RECRUITINGRehabilitation & Neurological Services, LLC
Huntsville, Alabama, United States
RECRUITINGMD First Research - Chandler - Neurology
Chandler, Arizona, United States
RECRUITINGMD First Research - Chandler
Chandler, Arizona, United States
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
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.
Time frame: For step 1: From baseline until end of study at Week 36
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.
Time frame: For step 1: At all timepoints post injection until Week 36
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Time frame: For step 1: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in facial examination
Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
Time frame: For step 1: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings
Time frame: For step 1: At all timepoints post injection until Week 36
Treatment-emergence of suicidal ideation/suicidal behaviour
It will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire that consists of 2 subscales: 1. Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe 2. Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation.
Time frame: For step 1: At all timepoints post injection until Week 36
Percentage of participants with Binding antibodies to IPN10200
Time frame: For step 1: At baseline, Week 4, Week 12 and Week 36.
Percentage of participants with neutralising antibodies to IPN10200
Time frame: For step 1: At baseline, Week 4, Week 12 and Week 36.
Change from baseline in the number of Monthly migraine days (MMD)s
Time frame: For step 2: At Week 12 (Weeks 9-12).
Change from baseline in the number of MMD
Time frame: For Step 1 and step 2: From Week 1 to Week 36.
Change from baseline in the number of Monthly Headache Days (MHD)
Time frame: For Step 1 and step 2: From Week 1 to Week 36
Change from baseline in the number of moderate/severe MHD
Time frame: For Step 1 and step 2: From Week 1 to Week 36
Migraine prevention response
Migraine prevention response is assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥75% in MMD
Time frame: For Step 1 and step 2: From Week 1 to Week 36
Headache prevention response
Assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥ 75% in MHD
Time frame: For Step 1 and step 2: From Week 1 to Week 36.
Change from baseline in the number of days per 4 week period of acute medication use for migraine relief.
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
Time frame: For Step 1 and step 2: From Week 1 to Week 36.
The use of acute migraine medication (yes or no)
The use of acute migraine medication will be recorded in the daily eDiary.
Time frame: For Step 1 and step 2: From Week 1 to Week 36.
Percentage of participants with Binding antibodies to IPN10200
Time frame: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.
Percentage of participants with neutralising antibodies to IPN10200
Time frame: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.
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