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

Status: Recruiting
Location: See all (159) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Central Research Associates
NOT_YET_RECRUITING
Birmingham
Rehabilitation & Neurological Services, LLC
RECRUITING
Huntsville
Arkansas
Baptist Health Center for Clinical Research
RECRUITING
Little Rock
Arizona
MD First Research - Chandler
RECRUITING
Chandler
MD First Research - Chandler - Neurology
RECRUITING
Chandler
California
Axiom Research, LLC
NOT_YET_RECRUITING
Apple Valley
Profound Research. LLC - NCSC
RECRUITING
Carlsbad
M3Wake -PRI Encino
RECRUITING
Encino
WR-PRI Encino
RECRUITING
Encino
Neuro-Pain Medical Center
RECRUITING
Fresno
Fullerton Neurological Center - Neurology
NOT_YET_RECRUITING
Fullerton
Neurology Center of North Orange County
NOT_YET_RECRUITING
Fullerton
University of California, Irvine - Department of Neurology
NOT_YET_RECRUITING
Irvine
Kaizen Brain Center
RECRUITING
La Jolla
Pharmacology Research Institute (PRI)
RECRUITING
Los Alamitos
Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach
RECRUITING
Newport Beach
Profound Research, LLC
RECRUITING
Pasadena
Acclaim Clinical Research - Internal Medicine
NOT_YET_RECRUITING
San Diego
Clinical Trials Management LLC
RECRUITING
Thousand Oaks
Alliance Clinical West Hills (Focus Clinical Research)
NOT_YET_RECRUITING
West Hills
Colorado
Advanced Neuroscience Research Center, LLC
RECRUITING
Fort Collins
Advanced Neuroscience Research Center, LLC - Neurology
RECRUITING
Fort Collins
Connecticut
New England Institute for Neurology and Headache (NEINH)/Medical Practice
NOT_YET_RECRUITING
Stamford
Florida
Neurology Offices
RECRUITING
Boca Raton
AGA Clinical Trials
NOT_YET_RECRUITING
Hialeah
M3 Wake Research/MSRA, LLC
RECRUITING
Lake City
M3 Wake Research/MSRA,LLC
RECRUITING
Lake City
Renstar Medical Research
RECRUITING
Ocala
Clinical Neuroscience Solutions, Inc.
NOT_YET_RECRUITING
Orlando
Emerald Coast Center For Neurological Disorders
RECRUITING
Pensacola
Conquest Research
NOT_YET_RECRUITING
Winter Park
Georgia
NeuroTrials Research, Inc.
NOT_YET_RECRUITING
Atlanta
Louisiana
Crescent City Headache and Neurology Center, LLC
RECRUITING
Chalmette
Ochsner Health Center - Covington
NOT_YET_RECRUITING
Covington
DelRicht Research
RECRUITING
New Orleans
DelRicht Research at Touro Medical Center
RECRUITING
New Orleans
LSU Healthcare Network Orthopedic & Sports Medicine
RECRUITING
New Orleans
Massachusetts
Neurology Center of NE,PC - Neurology
NOT_YET_RECRUITING
Foxborough
MedVadis Research
RECRUITING
Waltham
Mass Institute of Clinical Research
NOT_YET_RECRUITING
Westborough
Maryland
MedStar Franklin Square Hospital Center
RECRUITING
Baltimore
Medstar Franklin Square Medical Center
RECRUITING
Baltimore
MedStar Neurosciences and Rehabilitation
NOT_YET_RECRUITING
Baltimore
MedStar Neurosciences and Rehabilitation Research Network
RECRUITING
Baltimore
Michigan
Michigan Head Pain & Neurological Institute
RECRUITING
Ann Arbor
Michigan Head Pain & Neurological Institute - Neurology/Pain
RECRUITING
Ann Arbor
Michigan Center of Medical Research
RECRUITING
Grand Blanc
Minnesota
Minneapolis Clinic-Neurology
NOT_YET_RECRUITING
Burnsville
Nebraska
Papillion Research Center/Avacare
NOT_YET_RECRUITING
Papillion
Nevada
Alliance Clinical Las Vegas (Excel Clinical Research) - Internal Medicine
NOT_YET_RECRUITING
Las Vegas
New York
Integrative Clinical Trials, LLC
RECRUITING
Brooklyn
Montefiore Medical Center: Headache Center
RECRUITING
The Bronx
Upstate Clinical Research Associates
RECRUITING
Williamsville
Upstate Clinical Research Associates - Research Center
RECRUITING
Williamsville
Ohio
UC Gardner Neuroscience Institute
NOT_YET_RECRUITING
Cincinnati
Neurology Diagnostics, Inc.
RECRUITING
Dayton
Mount Carmel Health Systems
NOT_YET_RECRUITING
New Albany
Pennsylvania
Thomas Jefferson University
NOT_YET_RECRUITING
Philadelphia
Preferred Primary Care Physicians - Curry Hollow
RECRUITING
Pittsburgh
Tennessee
Clinical Neuroscience Solutions, Inc - Memphis
RECRUITING
Memphis
Clinical Neuroscience Solutions, Inc.
RECRUITING
Memphis
Texas
Zenos Clinical Research - Internal Medicine
NOT_YET_RECRUITING
Dallas
Lone Star Neurology
NOT_YET_RECRUITING
Frisco
Elevate Clinical Research - Houston
RECRUITING
Houston
Javara Inc. - Houston, TX
RECRUITING
Houston
Javara Inc. - New Caney, TX
RECRUITING
New Caney
Utah
J. Lewis Research-Site Number:8400053
NOT_YET_RECRUITING
Salt Lake City
ChronicleBio
NOT_YET_RECRUITING
West Valley City
Washington
Puget Sound Neurology - Neurology
RECRUITING
Tacoma
West Virginia
Marshall Health Clinical Research Center
NOT_YET_RECRUITING
Huntington
Frontier Clinical Research, LLC - Kingwood
NOT_YET_RECRUITING
Kingwood
Other Locations
Australia
The Alfred Hospital - Neurology
NOT_YET_RECRUITING
Melbourne
Western Health - Neurology & Stroke Services
NOT_YET_RECRUITING
Saint Albans
The Royal Melbourne Hospital - Neurology
NOT_YET_RECRUITING
Victoria Park
Brazil
Instituto de Neurologia de Curitiba
RECRUITING
Paraná
Associação Hospitalar Moinhos de Vento
RECRUITING
Rio Grande
A2Z Clinical
RECRUITING
São Paulo
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Pseg Centro de Pesquisa Clínica S.A
RECRUITING
São Paulo
Canada
CaRe Clinic - Calgary
NOT_YET_RECRUITING
Calgary
University of Calgary Foothills Campus
NOT_YET_RECRUITING
Calgary
Centre de Recherche Saint-Louis (Lévis) - Clinique Neuro-Lévis
RECRUITING
Lévis
Centre de Recherche Saint-Louis (Quebec) - Clinique Médicale Saint-Louis
RECRUITING
Québec
CaRe Clinic Red Deer
RECRUITING
Red Deer
Bluewater Clinical Research Group Inc.
RECRUITING
Sarnia
France
CHU Amiens Sud-Centre Rech Clinique
NOT_YET_RECRUITING
Amiens
Centre Hospitalier Regional Universtaire De Clermont-Ferrand - Neurologie
NOT_YET_RECRUITING
Clermont-ferrand
CHU de Nantes - Hôpital Laennec - Neurology
NOT_YET_RECRUITING
Nantes
CHU Nimes - Hôpital Caremeau - Service de Neurologie
NOT_YET_RECRUITING
Nîmes
Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal
NOT_YET_RECRUITING
Paris
Georgia
Ltd Health
RECRUITING
Batumi
LTD Israel-Georgian Medical Research Clinic Healthycore
RECRUITING
Tbilisi
LTD Multiprofile Clinic Consilium Medulla
RECRUITING
Tbilisi
LTD New Hospitals - Neurology
RECRUITING
Tbilisi
Ltd. S.Khechinashvili University Clinic
RECRUITING
Tbilisi
Pineo Medical Ecosystem LTD
RECRUITING
Tbilisi
Germany
Charite - Universitaetsmedizin Berlin - Neurology
NOT_YET_RECRUITING
Berlin
FutureMeds Berlin (emovis)
NOT_YET_RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden - UniversitaetsSchmerzCentrum - USC
NOT_YET_RECRUITING
Dresden
Universitätsklinikum Essen (AöR)
NOT_YET_RECRUITING
Essen
Kopfschmerzzentrum Frankfurt
NOT_YET_RECRUITING
Frankfurt
Praxis Dr. Oehlwein
NOT_YET_RECRUITING
Gera
Schmerz- und Palliativzentrum Goeppingen
NOT_YET_RECRUITING
Göppingen
Universitaetsmedizin Greifswald
NOT_YET_RECRUITING
Greifswald
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
NOT_YET_RECRUITING
Kiel
NeuroPoint
NOT_YET_RECRUITING
Ulm
Japan
Ikeda Neurosurgical Clinic - Neurosurgery
RECRUITING
Fukuoka
DOI Internal Medicine/Neurology Clinic
RECRUITING
Hiroshima
Konankai Konan Medical Center - Neurology
RECRUITING
Hyōgo
Tanaka Neurosurgery & Headache Clinic
RECRUITING
Kagoshima
Ishikawa Clinic
RECRUITING
Kyoto
Sendai Zutsu No-Shinkei Clinic - Neurology
RECRUITING
Miyagi
Tominaga Clinic - Neurology
RECRUITING
Osaka
Japanese Red Cross Shizuoka Hospital - Neurology
RECRUITING
Shizuoka
Iwata Neurosurgery Clinic
RECRUITING
Tokyo
Kitasato University Kitasato Institute Hospital - Urology - Neurology
RECRUITING
Tokyo
Nagamitsu Clinic - Neurology
RECRUITING
Yamaguchi
New Zealand
Optimal Clinical Trials
RECRUITING
Auckland
New Zealand Brain Research Institute at University of Otago
NOT_YET_RECRUITING
Christchurch
Optimal Clinical Trials - Christchurch
NOT_YET_RECRUITING
Christchurch
Pacific Clinical Research Network (PCRN) - Christchurch
NOT_YET_RECRUITING
Christchurch
Pacific Clinical Research Network (PCRN) - Tasman
NOT_YET_RECRUITING
Nelson
Pacific Clinical Research Network (PCRN) - Auckland
NOT_YET_RECRUITING
Takapuna
Lakeland Clinical Trials Wellington
RECRUITING
Upper Hutt
Poland
Synexus Polska Sp. z o.o.
NOT_YET_RECRUITING
Częstochowa
Silmedic sp. z o.o.
NOT_YET_RECRUITING
Katowice
Synexus Katowice
NOT_YET_RECRUITING
Katowice
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
NOT_YET_RECRUITING
Katowice
Centrum Medyczne PROMED
NOT_YET_RECRUITING
Krakow
CM Linden
NOT_YET_RECRUITING
Krakow
FutureMeds Krakow
NOT_YET_RECRUITING
Krakow
Specjalistyczne Gabinety Sp. z o.o.
NOT_YET_RECRUITING
Krakow
FutureMeds Lodz
NOT_YET_RECRUITING
Lodz
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
NOT_YET_RECRUITING
Oświęcim
Synexus Polska Sp. z o.o. - Oddzial w Gdyni
NOT_YET_RECRUITING
Pomorskie
Velocity Nova Sp. z o.o - Velocity Pulawy
NOT_YET_RECRUITING
Puławy
ETG Siedlce
NOT_YET_RECRUITING
Siedlce
Centrum Leczenia Zaburzen Pamieci i Neuroobrazowania Affidea
NOT_YET_RECRUITING
Warsaw
City Clinic Research Sp. z o.o.
NOT_YET_RECRUITING
Warsaw
ETG Neuroscience Sp. z o.o.
NOT_YET_RECRUITING
Warsaw
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
NOT_YET_RECRUITING
Wroclaw
Republic of Korea
Hallym University Dongtan Sacred Heart Hospital - Neurology
RECRUITING
Gyeonggi-do
Inje University Ilsan Paik Hospital - Allergology
RECRUITING
Gyeonggi-do
Ewha Womans University Seoul Hospital - Neurology
RECRUITING
Seoul
Kangbuk Samsung Hospital - Neurology
RECRUITING
Seoul
Nowon Eulji Medical Center, Eulji University - Neurology
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Clinic de Barcelona - Neurología
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - Enfermedades Infecciosas
NOT_YET_RECRUITING
Barcelona
FutureMeds Spain Cádiz
NOT_YET_RECRUITING
Cadiz
FutureMeds Madrid
NOT_YET_RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla - Neurologia
NOT_YET_RECRUITING
Santander
Hospital Universitario Virgen del Rocio
NOT_YET_RECRUITING
Seville
Hospital Clinico Universitario de Valladolid - Gastroenterology
NOT_YET_RECRUITING
Valladolid
United Kingdom
Royal Devon And Exeter Hospital - Neurology
NOT_YET_RECRUITING
Exeter
Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary
NOT_YET_RECRUITING
Hull
Walton Centre For Neurology And Neurosurgery
NOT_YET_RECRUITING
Liverpool
King's College Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Ipsen Clinical Study Enquiries
clinical.trials@ipsen.com
See e mail
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2027-06-15
Participants
Target number of participants: 641
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Ipsen

This content was sourced from clinicaltrials.gov

Similar Clinical Trials