A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
Start Date
10/10/2024
Completion Date
10/31/2027
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. 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.
Detailed Description
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).
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
Corabotase
Placebo
Corabotase dose A
Corabotase dose B
Conditions
Locations
Central Research Associates
Birmingham, Alabama 35205
United States
Rehabilitation & Neurological Services, LLC
Huntsville, Alabama 35801
United States
MD First Research - Chandler - Neurology
Chandler, Arizona 85224
United States
MD First Research - Chandler
Chandler, Arizona 85286
United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas 72205
United States
Axiom Research, LLC
Apple Valley, California 92308
United States
Profound Research. LLC - NCSC
Carlsbad, California 92011
United States
M3Wake -PRI Encino
Encino, California 91316
United States
WR-PRI Encino
Encino, California 91316
United States
Neuro-Pain Medical Center
Fresno, California 93710
United States
Fullerton Neurological Center - Neurology
Fullerton, California 92832
United States
Neurology Center of North Orange County
Fullerton, California 92832
United States
University of California, Irvine - Department of Neurology
Irvine, California 92697
United States
Kaizen Brain Center
La Jolla, California 92037
United States
Pharmacology Research Institute (PRI)
Los Alamitos, California 90720
United States
Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach
Newport Beach, California 92660
United States
Profound Research, LLC
Pasadena, California 91105
United States
Acclaim Clinical Research - Internal Medicine
San Diego, California 92101
United States
Clinical Trials Management LLC
Thousand Oaks, California 91360
United States
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California 91307
United States
Advanced Neuroscience Research Center, LLC
Fort Collins, Colorado 80501
United States
Advanced Neuroscience Research Center, LLC - Neurology
Fort Collins, Colorado 80524
United States
New England Institute for Neurology and Headache (NEINH)/Medical Practice
Stamford, Connecticut 06901
United States
Neurology Offices
Boca Raton, Florida 33432
United States
AGA Clinical Trials
Hialeah, Florida 33012
United States
M3 Wake Research/MSRA, LLC
Lake City, Florida 32055
United States
M3 Wake Research/MSRA,LLC
Lake City, Florida 32055
United States
Renstar Medical Research
Ocala, Florida 34471
United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801
United States
Emerald Coast Center For Neurological Disorders
Pensacola, Florida 32502
United States
Conquest Research
Winter Park, Florida 32789
United States
NeuroTrials Research, Inc.
Atlanta, Georgia 30309
United States
Crescent City Headache and Neurology Center, LLC
Chalmette, Louisiana 70043
United States
Ochsner Health Center - Covington
Covington, Louisiana 70433
United States
DelRicht Research
New Orleans, Louisiana 70112
United States
DelRicht Research at Touro Medical Center
New Orleans, Louisiana 70115
United States
LSU Healthcare Network Orthopedic & Sports Medicine
New Orleans, Louisiana 70115
United States
MedStar Neurosciences and Rehabilitation Research Network
Baltimore, Maryland 21218
United States
MedStar Neurosciences and Rehabilitation
Baltimore, Maryland 21218
United States
MedStar Franklin Square Hospital Center
Baltimore, Maryland 21237
United States
Medstar Franklin Square Medical Center
Baltimore, Maryland 21237
United States
Neurology Center of NE,PC - Neurology
Foxborough, Massachusetts 02035
United States
MedVadis Research
Waltham, Massachusetts 02451
United States
Mass Institute of Clinical Research
Westborough, Massachusetts 01581
United States
Michigan Head Pain & Neurological Institute - Neurology/Pain
Ann Arbor, Michigan 48104
United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan 48104
United States
Michigan Center of Medical Research
Grand Blanc, Michigan 48439
United States
Minneapolis Clinic-Neurology
Burnsville, Minnesota 55306
United States
Papillion Research Center/Avacare
Papillion, Nebraska 68046
United States
Alliance Clinical Las Vegas (Excel Clinical Research) - Internal Medicine
Las Vegas, Nevada 89101
United States
Integrative Clinical Trials, LLC
Brooklyn, New York 11229
United States
Montefiore Medical Center: Headache Center
The Bronx, New York 10461
United States
Upstate Clinical Research Associates - Research Center
Williamsville, New York 14221
United States
Upstate Clinical Research Associates
Williamsville, New York 14221
United States
UC Gardner Neuroscience Institute
Cincinnati, Ohio 45219
United States
Neurology Diagnostics, Inc.
Dayton, Ohio 45459
United States
Mount Carmel Health Systems
New Albany, Ohio 43054
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Preferred Primary Care Physicians - Curry Hollow
Pittsburgh, Pennsylvania 15236
United States
Clinical Neuroscience Solutions, Inc - Memphis
Memphis, Tennessee 38119
United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
United States
Zenos Clinical Research - Internal Medicine
Dallas, Texas 75201
United States
Lone Star Neurology
Frisco, Texas 75034
United States
Elevate Clinical Research - Houston
Houston, Texas 77002
United States
Javara Inc. - Houston, TX
Houston, Texas 77002
United States
Javara Inc. - New Caney, TX
New Caney, Texas 77357
United States
J. Lewis Research-Site Number:8400053
Salt Lake City, Utah 84101
United States
ChronicleBio
West Valley City, Utah 84119
United States
Puget Sound Neurology - Neurology
Tacoma, Washington 98409
United States
Marshall Health Clinical Research Center
Huntington, West Virginia 25701
United States
Frontier Clinical Research, LLC - Kingwood
Kingwood, West Virginia 26537
United States
The Alfred Hospital - Neurology
Melbourne,
Australia
Western Health - Neurology & Stroke Services
Saint Albans,
Australia
The Royal Melbourne Hospital - Neurology
Victoria Park,
Australia
Instituto de Neurologia de Curitiba
Paraná,
Brazil
Associação Hospitalar Moinhos de Vento
Rio Grande,
Brazil
A2Z Clinical
São Paulo,
Brazil
Hospital Alemao Oswaldo Cruz
São Paulo,
Brazil
Pseg Centro de Pesquisa Clínica S.A
São Paulo,
Brazil
CaRe Clinic - Calgary
Calgary,
Canada
University of Calgary Foothills Campus
Calgary,
Canada
Centre de Recherche Saint-Louis (Lévis) - Clinique Neuro-Lévis
Lévis,
Canada
Centre de Recherche Saint-Louis (Quebec) - Clinique Médicale Saint-Louis
Québec,
Canada
CaRe Clinic Red Deer
Red Deer,
Canada
Bluewater Clinical Research Group Inc.
Sarnia,
Canada
Pratia Brno s.r.o.
Brno,
Czechia
NEUROHK s.r.o.
Choceň,
Czechia
NeuropsychiatrieHK, s.r.o.
Hradec Králové,
Czechia
Fakultni nemocnice Ostrava - Neurologicka klinika
Ostrava,
Czechia
Pratia Pardubice a.s.
Pardubice,
Czechia
AXON clinical
Prague,
Czechia
DADO MEDICAL s.r.o.
Prague,
Czechia
CHU Amiens Sud-Centre Rech Clinique
Amiens,
France
Centre Hospitalier Regional Universtaire De Clermont-Ferrand - Neurologie
Clermont-Ferrand,
France
CHU de Nantes - Hôpital Laennec - Neurology
Nantes,
France
CHU Nimes - Hôpital Caremeau - Service de Neurologie
Nîmes,
France
Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal
Paris,
France
Ltd "Health"
Batumi,
Georgia
"Pineo Medical Ecosystem" LTD
Tbilisi,
Georgia
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi,
Georgia
LTD "Multiprofile Clinic Consilium Medulla"
Tbilisi,
Georgia
LTD New Hospitals - Neurology
Tbilisi,
Georgia
Ltd. S.Khechinashvili University Clinic
Tbilisi,
Georgia
Charite - Universitaetsmedizin Berlin - Neurology
Berlin,
Germany
FutureMeds Berlin (emovis)
Berlin,
Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden - UniversitaetsSchmerzCentrum - USC
Dresden,
Germany
Universitätsklinikum Essen (AöR)
Essen,
Germany
Kopfschmerzzentrum Frankfurt
Frankfurt,
Germany
Praxis Dr. Oehlwein
Gera,
Germany
Schmerz- und Palliativzentrum Goeppingen
Göppingen,
Germany
Universitaetsmedizin Greifswald
Greifswald,
Germany
Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
Kiel,
Germany
NeuroPoint
Ulm,
Germany
Ikeda Neurosurgical Clinic - Neurosurgery
Fukuoka,
Japan
DOI Internal Medicine/Neurology Clinic
Hiroshima,
Japan
Konankai Konan Medical Center - Neurology
Hyōgo,
Japan
Tanaka Neurosurgery & Headache Clinic
Kagoshima,
Japan
Ishikawa Clinic
Kyoto,
Japan
Sendai Zutsu No-Shinkei Clinic - Neurology
Miyagi,
Japan
Tominaga Clinic - Neurology
Osaka,
Japan
Japanese Red Cross Shizuoka Hospital - Neurology
Shizuoka,
Japan
Iwata Neurosurgery Clinic
Tokyo,
Japan
Kitasato University Kitasato Institute Hospital - Urology - Neurology
Tokyo,
Japan
Nagamitsu Clinic - Neurology
Yamaguchi,
Japan
Optimal Clinical Trials
Auckland,
New Zealand
New Zealand Brain Research Institute at University of Otago
Christchurch,
New Zealand
Optimal Clinical Trials - Christchurch
Christchurch,
New Zealand
Pacific Clinical Research Network (PCRN) - Christchurch
Christchurch,
New Zealand
Pacific Clinical Research Network (PCRN) - Tasman
Nelson,
New Zealand
Pacific Clinical Research Network (PCRN) - Auckland
Takapuna,
New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt,
New Zealand
Synexus Polska Sp. z o.o.
Częstochowa,
Poland
Silmedic sp. z o.o.
Katowice,
Poland
Synexus Katowice
Katowice,
Poland
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice,
Poland
Centrum Medyczne PROMED
Krakow,
Poland
CM Linden
Krakow,
Poland
FutureMeds Krakow
Krakow,
Poland
Specjalistyczne Gabinety Sp. z o.o.
Krakow,
Poland
FutureMeds Lodz
Lodz,
Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Oświęcim,
Poland
Synexus Polska Sp. z o.o. - Oddzial w Gdyni
Pomorskie,
Poland
Velocity Nova Sp. z o.o - Velocity Pulawy
Puławy,
Poland
ETG Siedlce
Siedlce,
Poland
Centrum Leczenia Zaburzen Pamieci i Neuroobrazowania Affidea
Warsaw,
Poland
City Clinic Research Sp. z o.o.
Warsaw,
Poland
ETG Neuroscience Sp. z o.o.
Warsaw,
Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw,
Poland
Hallym University Dongtan Sacred Heart Hospital - Neurology
Gyeonggi-do,
South Korea
Inje University Ilsan Paik Hospital - Allergology
Gyeonggi-do,
South Korea
Ewha Womans University Seoul Hospital - Neurology
Seoul,
South Korea
Kangbuk Samsung Hospital - Neurology
Seoul,
South Korea
Nowon Eulji Medical Center, Eulji University - Neurology
Seoul,
South Korea
Seoul National University Hospital
Seoul,
South Korea
Severance Hospital, Yonsei University Health System
Seoul,
South Korea
Hospital Clinic de Barcelona - Neurología
Barcelona,
Spain
Hospital Universitario Vall d'Hebron - Enfermedades Infecciosas
Barcelona,
Spain
FutureMeds Spain Cádiz
Cadiz,
Spain
FutureMeds Madrid
Madrid,
Spain
Hospital Universitario Marqués de Valdecilla - Neurologia
Santander,
Spain
Hospital Universitario Virgen del Rocio
Seville,
Spain
Hospital Clinico Universitario de Valladolid - Gastroenterology
Valladolid,
Spain
Royal Devon And Exeter Hospital - Neurology
Exeter,
United Kingdom
Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary
Hull,
United Kingdom
Walton Centre For Neurology And Neurosurgery
Liverpool,
United Kingdom
King's College Hospital
London,
United Kingdom