Идёт набор NCT06625060

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

Фаза II С лечением Episodic Migraine Chronic Migraine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Corabotase, Placebo, Corabotase dose A, Corabotase dose B.
Кому может быть актуально: Состояния в реестре: Episodic Migraine, Chronic Migraine. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия, Бразилия, Канада, Чехия +9
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose Escalation and Dose Finding Phase II Study to Evaluate the Safety and Efficacy of IPN10200 in the Prevention of Episodic or Chronic Migraine in Adults

Обзор

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. Corabotase (also known as 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 Corabotase directly into the muscles of the head and neck to prevent EM and CM, * The right amount (dose) of Corabotase to inject at each point, * The total amount (dose) of Corabotase 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.

Подробное описание

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 Corabotase, 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).

Вмешательства

Биопрепарат Corabotase
Lyophilised powder
Другое Placebo
Excipients without active substance, Lyophilised powder
Биопрепарат Corabotase dose A
Lyophilised powder
Биопрепарат Corabotase dose B
Lyophilised powder

Первичные конечные точки

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 [Срок оценки: For step 1: From baseline until end of study at Week 36]
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters [Срок оценки: For step 1: At all timepoints post injection until Week 36]
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs [Срок оценки: For step 1: At all timepoints post injection until Week 36]
Percentage of participants with clinically significant change from baseline in facial examination [Срок оценки: 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 [Срок оценки: For step 1: At all timepoints post injection until Week 36]
Treatment-emergence of suicidal ideation/suicidal behaviour [Срок оценки: For step 1: At all timepoints post injection until Week 36]
Percentage of participants with Binding antibodies to IPN10200 [Срок оценки: For step 1: At baseline, Week 4, Week 12 and Week 36.]
Percentage of participants with neutralising antibodies to IPN10200 [Срок оценки: For step 1: At baseline, Week 4, Week 12 and Week 36.]
Change from baseline in the number of Monthly migraine days (MMD)s [Срок оценки: For step 2: At Week 12 (Weeks 9-12).]

Вторичные конечные точки (9)

Change from baseline in the number of MMD [Срок оценки: For Step 1 and step 2: From Week 1 to Week 36.]
Change from baseline in the number of Monthly Headache Days (MHD) [Срок оценки: For Step 1 and step 2: From Week 1 to Week 36]
Change from baseline in the number of moderate/severe MHD [Срок оценки: For Step 1 and step 2: From Week 1 to Week 36]
Migraine prevention response [Срок оценки: For Step 1 and step 2: From Week 1 to Week 36]
Headache prevention response [Срок оценки: 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. [Срок оценки: For Step 1 and step 2: From Week 1 to Week 36.]
The use of acute migraine medication (yes or no) [Срок оценки: For Step 1 and step 2: From Week 1 to Week 36.]
Percentage of participants with Binding antibodies to IPN10200 [Срок оценки: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.]
Percentage of participants with neutralising antibodies to IPN10200 [Срок оценки: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36.]

Критерии участия

Критерии включения

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. Participant has provided written informed consent and signed privacy/data protection documentation;
Male or female ≥18 to 80 years of age at the time of signing the informed consent;
Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior to the screening visit;
Diagnosis of migraine at ≤50 years of age;
Participants in the EM group: History of EM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≤14 headache days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥6 migraine days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary;
Participants in the CM group: History of CM diagnosis and headache frequency (i.e. migraine and non-migraine headache): ≥15 headache days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥8 migraine days in the 4 weeks prior to randomisation on study Day 1 based on information recorded in the eDiary;
Participant with a history of use of at least one preventive treatment for migraine.

Критерии исключения

History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua or new daily persistent headache;
Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH);
Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation;
Risk of self-harm or harm to others as evidenced by past suicidal behaviour or endorsing items 3, 4, or 5 on the C-SSRS at screening or Day 1.
Participants presenting with a swallowing disorder of any origin which might be exacerbated by botulinum toxin treatment, such as:

\- Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet.

Clinically relevant skin condition or infection that could interfere with injection of study intervention;
Participant has any medical condition or situation that would make them unsuitable for participation in the study;
Participant receiving more than one allowable concomitant migraine preventive treatment;
Known history of an inadequate response to >4 medications prescribed for the prevention of migraine (2 of which have different mechanisms of action to botulinum toxin);
Use of any of the following medications in the specified timeframe prior to the screening visit:

Botulinum toxin for migraine within 24 weeks (or for any other medical/aesthetic reason within 16 weeks);
Prior use of mAbs blocking CGRP pathway within 12 weeks for preventative treatment of migraine
Prior use of oral CGRP receptor antagonist (gepants) for preventative treatment of migraine within 2 weeks;
Anaesthetic or steroid injection in any region targeted for treatment with study medication within 4 weeks;
Use of cannabidiol or other types of cannabinoids within 30 days;
Use of medical device to treat migraine within 4 weeks (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation and peripheral neuroelectrical stimulation);
Use of other intervention to treat migraine that is assessed to interfere with study evaluations within 4 weeks (e.g. acupuncture in the head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments and dental splints for headache);
Use of opioids or barbiturates for more than 2 days/month within the last 4 weeks.
Concurrent participation in another interventional clinical study (or within specified timeframe according to national or local legislation or requirements);
Diagnosis of other significant pain disorders that could confound the assessment of headaches/migraines or interfere with study participation, including but not limited to chronic pain disorders such as fibromyalgia, chronic low back pain and complex regional pain syndrome;
Pregnant women, nursing women, premenopausal women, or WOCBP (i.e. not surgically sterile or 1 year postmenopausal) not willing to practice an acceptable contraceptive method, at the beginning of the study and for a minimum of 12 weeks following the administration of study treatment;
Male subjects who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide for a minimum of 12 weeks following the initial double-blind administration of the treatment;
History of alcohol or drug abuse within 5 years of the screening visit (excluding medication overuse for headache);
Body mass index (BMI) ≥35 kg/m² at the screening visit;
Known clinically significant hypersensitivity to any of the study drugs, excipients or materials used to administer the study drug;
Patients who, in the clinician's judgment, are actively suicidal, and therefore, deemed to be at significant risk for suicide.
A diagnosis of a neuromuscular disorder or respiratory disorder, such as myasthenia gravis, Lambert-Eaton syndrome or amyotrophic lateral sclerosis that in the opinion of the investigator would compromise the safety of the study participant.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение