Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06625060

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

Led by Ipsen · Updated on 2026-05-05

641

Participants Needed

166

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide signed informed consent
  • Male or female aged 18 to 80 years at consent
  • Diagnosed with episodic or chronic migraine for at least 12 months
  • Migraine diagnosis occurred at age 50 or younger
  • For episodic migraine group: 14 or fewer headache days and 6 or more migraine days in the 4 weeks before randomization
  • For chronic migraine group: 15 or more headache days and 8 or more migraine days in the 4 weeks before randomization
  • History of using at least one preventive migraine treatment
Not Eligible

You will not qualify if you...

  • History or current diagnosis of migraine with brainstem aura, retinal migraine, or other specified headache types
  • Headaches caused by other disorders except medication overuse headache
  • Uncontrolled psychiatric or psychological conditions or risk of self-harm
  • Severe swallowing disorders that might worsen with botulinum toxin treatment
  • Skin conditions or infections interfering with injections
  • Any medical condition making participation unsuitable
  • Using more than one migraine preventive treatment currently
  • History of poor response to more than four migraine prevention medications
  • Use of certain migraine treatments or devices within specific timeframes before screening
  • Participation in another interventional clinical study
  • Other significant pain disorders that could affect headache assessment
  • Pregnant, nursing, or women of childbearing potential not using contraception
  • Male participants not vasectomised and not using condoms with spermicide
  • History of alcohol or drug abuse within 5 years
  • Body mass index of 35 kg/m2 or higher
  • Known severe allergies to study drugs or materials
  • Actively suicidal or judged at significant risk for suicide
  • Neuromuscular or respiratory disorders like myasthenia gravis or amyotrophic lateral sclerosis that compromise safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 166 locations

1

Central Research Associates

Birmingham, Alabama, United States, 35205

Not Yet Recruiting

2

Rehabilitation & Neurological Services, LLC

Huntsville, Alabama, United States, 35801

Actively Recruiting

3

MD First Research - Chandler - Neurology

Chandler, Arizona, United States, 85224

Actively Recruiting

4

MD First Research - Chandler

Chandler, Arizona, United States, 85286

Actively Recruiting

5

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States, 72205

Withdrawn

6

Axiom Research, LLC

Apple Valley, California, United States, 92308

Not Yet Recruiting

7

Profound Research. LLC - NCSC

Carlsbad, California, United States, 92011

Actively Recruiting

8

M3Wake -PRI Encino

Encino, California, United States, 91316

Actively Recruiting

9

WR-PRI Encino

Encino, California, United States, 91316

Actively Recruiting

10

Neuro-Pain Medical Center

Fresno, California, United States, 93710

Actively Recruiting

11

Fullerton Neurological Center - Neurology

Fullerton, California, United States, 92832

Actively Recruiting

12

Neurology Center of North Orange County

Fullerton, California, United States, 92832

Not Yet Recruiting

13

University of California, Irvine - Department of Neurology

Irvine, California, United States, 92697

Withdrawn

14

Kaizen Brain Center

La Jolla, California, United States, 92037

Actively Recruiting

15

Pharmacology Research Institute (PRI)

Los Alamitos, California, United States, 90720

Actively Recruiting

16

Pharmacology Research Institute (PRI) - Los Alamitos/Long Beach

Newport Beach, California, United States, 92660

Actively Recruiting

17

Profound Research, LLC

Pasadena, California, United States, 91105

Actively Recruiting

18

Acclaim Clinical Research - Internal Medicine

San Diego, California, United States, 92101

Not Yet Recruiting

19

Clinical Trials Management LLC

Thousand Oaks, California, United States, 91360

Actively Recruiting

20

Alliance Clinical West Hills (Focus Clinical Research)

West Hills, California, United States, 91307

Not Yet Recruiting

21

Advanced Neuroscience Research Center, LLC

Fort Collins, Colorado, United States, 80501

Actively Recruiting

22

Advanced Neuroscience Research Center, LLC - Neurology

Fort Collins, Colorado, United States, 80524

Actively Recruiting

23

New England Institute for Neurology and Headache (NEINH)/Medical Practice

Stamford, Connecticut, United States, 06901

Not Yet Recruiting

24

Neurology Offices

Boca Raton, Florida, United States, 33432

Actively Recruiting

25

AGA Clinical Trials

Hialeah, Florida, United States, 33012

Not Yet Recruiting

26

M3 Wake Research/MSRA, LLC

Lake City, Florida, United States, 32055

Actively Recruiting

27

M3 Wake Research/MSRA,LLC

Lake City, Florida, United States, 32055

Actively Recruiting

28

Renstar Medical Research

Ocala, Florida, United States, 34471

Actively Recruiting

29

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States, 32801

Not Yet Recruiting

30

Emerald Coast Center For Neurological Disorders

Pensacola, Florida, United States, 32502

Actively Recruiting

31

Conquest Research

Winter Park, Florida, United States, 32789

Not Yet Recruiting

32

NeuroTrials Research, Inc.

Atlanta, Georgia, United States, 30309

Not Yet Recruiting

33

Crescent City Headache and Neurology Center, LLC

Chalmette, Louisiana, United States, 70043

Actively Recruiting

34

Ochsner Health Center - Covington

Covington, Louisiana, United States, 70433

Not Yet Recruiting

35

DelRicht Research

New Orleans, Louisiana, United States, 70112

Actively Recruiting

36

DelRicht Research at Touro Medical Center

New Orleans, Louisiana, United States, 70115

Actively Recruiting

37

LSU Healthcare Network Orthopedic & Sports Medicine

New Orleans, Louisiana, United States, 70115

Actively Recruiting

38

MedStar Neurosciences and Rehabilitation Research Network

Baltimore, Maryland, United States, 21218

Actively Recruiting

39

MedStar Neurosciences and Rehabilitation

Baltimore, Maryland, United States, 21218

Not Yet Recruiting

40

MedStar Franklin Square Hospital Center

Baltimore, Maryland, United States, 21237

Actively Recruiting

41

Medstar Franklin Square Medical Center

Baltimore, Maryland, United States, 21237

Actively Recruiting

42

Neurology Center of NE,PC - Neurology

Foxborough, Massachusetts, United States, 02035

Not Yet Recruiting

43

MedVadis Research

Waltham, Massachusetts, United States, 02451

Actively Recruiting

44

Mass Institute of Clinical Research

Westborough, Massachusetts, United States, 01581

Not Yet Recruiting

45

Michigan Head Pain & Neurological Institute - Neurology/Pain

Ann Arbor, Michigan, United States, 48104

Actively Recruiting

46

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan, United States, 48104

Actively Recruiting

47

Michigan Center of Medical Research

Grand Blanc, Michigan, United States, 48439

Actively Recruiting

48

Minneapolis Clinic-Neurology

Burnsville, Minnesota, United States, 55306

Actively Recruiting

49

Papillion Research Center/Avacare

Papillion, Nebraska, United States, 68046

Not Yet Recruiting

50

Alliance Clinical Las Vegas (Excel Clinical Research) - Internal Medicine

Las Vegas, Nevada, United States, 89101

Not Yet Recruiting

51

Integrative Clinical Trials, LLC

Brooklyn, New York, United States, 11229

Actively Recruiting

52

Montefiore Medical Center: Headache Center

The Bronx, New York, United States, 10461

Actively Recruiting

53

Upstate Clinical Research Associates - Research Center

Williamsville, New York, United States, 14221

Actively Recruiting

54

Upstate Clinical Research Associates

Williamsville, New York, United States, 14221

Actively Recruiting

55

UC Gardner Neuroscience Institute

Cincinnati, Ohio, United States, 45219

Not Yet Recruiting

56

Neurology Diagnostics, Inc.

Dayton, Ohio, United States, 45459

Actively Recruiting

57

Mount Carmel Health Systems

New Albany, Ohio, United States, 43054

Withdrawn

58

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Not Yet Recruiting

59

Preferred Primary Care Physicians - Curry Hollow

Pittsburgh, Pennsylvania, United States, 15236

Actively Recruiting

60

Clinical Neuroscience Solutions, Inc - Memphis

Memphis, Tennessee, United States, 38119

Actively Recruiting

61

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States, 38119

Actively Recruiting

62

Zenos Clinical Research - Internal Medicine

Dallas, Texas, United States, 75201

Not Yet Recruiting

63

Lone Star Neurology

Frisco, Texas, United States, 75034

Not Yet Recruiting

64

Elevate Clinical Research - Houston

Houston, Texas, United States, 77002

Actively Recruiting

65

Javara Inc. - Houston, TX

Houston, Texas, United States, 77002

Actively Recruiting

66

Javara Inc. - New Caney, TX

New Caney, Texas, United States, 77357

Actively Recruiting

67

J. Lewis Research-Site Number:8400053

Salt Lake City, Utah, United States, 84101

Not Yet Recruiting

68

ChronicleBio

West Valley City, Utah, United States, 84119

Not Yet Recruiting

69

Puget Sound Neurology - Neurology

Tacoma, Washington, United States, 98409

Actively Recruiting

70

Marshall Health Clinical Research Center

Huntington, West Virginia, United States, 25701

Not Yet Recruiting

71

Frontier Clinical Research, LLC - Kingwood

Kingwood, West Virginia, United States, 26537

Not Yet Recruiting

72

The Alfred Hospital - Neurology

Melbourne, Australia

Not Yet Recruiting

73

Western Health - Neurology & Stroke Services

Saint Albans, Australia

Not Yet Recruiting

74

The Royal Melbourne Hospital - Neurology

Victoria Park, Australia

Not Yet Recruiting

75

Instituto de Neurologia de Curitiba

Paraná, Brazil

Actively Recruiting

76

Associação Hospitalar Moinhos de Vento

Rio Grande, Brazil

Actively Recruiting

77

A2Z Clinical

São Paulo, Brazil

Actively Recruiting

78

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Actively Recruiting

79

Pseg Centro de Pesquisa Clínica S.A

São Paulo, Brazil

Actively Recruiting

80

CaRe Clinic - Calgary

Calgary, Canada

Not Yet Recruiting

81

University of Calgary Foothills Campus

Calgary, Canada

Not Yet Recruiting

82

Centre de Recherche Saint-Louis (Lévis) - Clinique Neuro-Lévis

Lévis, Canada

Actively Recruiting

83

Centre de Recherche Saint-Louis (Quebec) - Clinique Médicale Saint-Louis

Québec, Canada

Actively Recruiting

84

CaRe Clinic Red Deer

Red Deer, Canada

Actively Recruiting

85

Bluewater Clinical Research Group Inc.

Sarnia, Canada

Actively Recruiting

86

Pratia Brno s.r.o.

Brno, Czechia

Actively Recruiting

87

NEUROHK s.r.o.

Choceň, Czechia

Actively Recruiting

88

NeuropsychiatrieHK, s.r.o.

Hradec Králové, Czechia

Actively Recruiting

89

Fakultni nemocnice Ostrava - Neurologicka klinika

Ostrava, Czechia

Not Yet Recruiting

90

Pratia Pardubice a.s.

Pardubice, Czechia

Actively Recruiting

91

AXON clinical

Prague, Czechia

Actively Recruiting

92

DADO MEDICAL s.r.o.

Prague, Czechia

Actively Recruiting

93

CHU Amiens Sud-Centre Rech Clinique

Amiens, France

Actively Recruiting

94

Centre Hospitalier Regional Universtaire De Clermont-Ferrand - Neurologie

Clermont-Ferrand, France

Not Yet Recruiting

95

CHU de Nantes - Hôpital Laennec - Neurology

Nantes, France

Not Yet Recruiting

96

CHU Nimes - Hôpital Caremeau - Service de Neurologie

Nîmes, France

Actively Recruiting

97

Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal

Paris, France

Not Yet Recruiting

98

Ltd "Health"

Batumi, Georgia

Actively Recruiting

99

"Pineo Medical Ecosystem" LTD

Tbilisi, Georgia

Actively Recruiting

100

LTD "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia

Actively Recruiting

101

LTD "Multiprofile Clinic Consilium Medulla"

Tbilisi, Georgia

Actively Recruiting

102

LTD New Hospitals - Neurology

Tbilisi, Georgia

Actively Recruiting

103

Ltd. S.Khechinashvili University Clinic

Tbilisi, Georgia

Actively Recruiting

104

Charite - Universitaetsmedizin Berlin - Neurology

Berlin, Germany

Not Yet Recruiting

105

FutureMeds Berlin (emovis)

Berlin, Germany

Actively Recruiting

106

Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden - UniversitaetsSchmerzCentrum - USC

Dresden, Germany

Not Yet Recruiting

107

Universitätsklinikum Essen (AöR)

Essen, Germany

Actively Recruiting

108

Kopfschmerzzentrum Frankfurt

Frankfurt, Germany

Not Yet Recruiting

109

Praxis Dr. Oehlwein

Gera, Germany

Actively Recruiting

110

Schmerz- und Palliativzentrum Goeppingen

Göppingen, Germany

Actively Recruiting

111

Universitaetsmedizin Greifswald

Greifswald, Germany

Not Yet Recruiting

112

Neurologisch-verhaltensmedizinische Schmerzklinik Kiel

Kiel, Germany

Withdrawn

113

NeuroPoint

Ulm, Germany

Not Yet Recruiting

114

Ikeda Neurosurgical Clinic - Neurosurgery

Fukuoka, Japan

Actively Recruiting

115

DOI Internal Medicine/Neurology Clinic

Hiroshima, Japan

Actively Recruiting

116

Konankai Konan Medical Center - Neurology

Hyōgo, Japan

Actively Recruiting

117

Tanaka Neurosurgery & Headache Clinic

Kagoshima, Japan

Actively Recruiting

118

Ishikawa Clinic

Kyoto, Japan

Actively Recruiting

119

Sendai Zutsu No-Shinkei Clinic - Neurology

Miyagi, Japan

Actively Recruiting

120

Tominaga Clinic - Neurology

Osaka, Japan

Actively Recruiting

121

Japanese Red Cross Shizuoka Hospital - Neurology

Shizuoka, Japan

Actively Recruiting

122

Iwata Neurosurgery Clinic

Tokyo, Japan

Actively Recruiting

123

Kitasato University Kitasato Institute Hospital - Urology - Neurology

Tokyo, Japan

Actively Recruiting

124

Nagamitsu Clinic - Neurology

Yamaguchi, Japan

Actively Recruiting

125

Optimal Clinical Trials

Auckland, New Zealand

Actively Recruiting

126

New Zealand Brain Research Institute at University of Otago

Christchurch, New Zealand

Not Yet Recruiting

127

Optimal Clinical Trials - Christchurch

Christchurch, New Zealand

Not Yet Recruiting

128

Pacific Clinical Research Network (PCRN) - Christchurch

Christchurch, New Zealand

Not Yet Recruiting

129

Pacific Clinical Research Network (PCRN) - Tasman

Nelson, New Zealand

Not Yet Recruiting

130

Pacific Clinical Research Network (PCRN) - Auckland

Takapuna, New Zealand

Not Yet Recruiting

131

Lakeland Clinical Trials Wellington

Upper Hutt, New Zealand

Actively Recruiting

132

Synexus Polska Sp. z o.o.

Częstochowa, Poland

Actively Recruiting

133

Silmedic sp. z o.o.

Katowice, Poland

Actively Recruiting

134

Synexus Katowice

Katowice, Poland

Actively Recruiting

135

Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, Poland

Not Yet Recruiting

136

Centrum Medyczne PROMED

Krakow, Poland

Actively Recruiting

137

CM Linden

Krakow, Poland

Actively Recruiting

138

FutureMeds Krakow

Krakow, Poland

Actively Recruiting

139

Specjalistyczne Gabinety Sp. z o.o.

Krakow, Poland

Not Yet Recruiting

140

FutureMeds Lodz

Lodz, Poland

Actively Recruiting

141

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.

Oświęcim, Poland

Not Yet Recruiting

142

Synexus Polska Sp. z o.o. - Oddzial w Gdyni

Pomorskie, Poland

Actively Recruiting

143

Velocity Nova Sp. z o.o - Velocity Pulawy

Puławy, Poland

Actively Recruiting

144

ETG Siedlce

Siedlce, Poland

Actively Recruiting

145

Centrum Leczenia Zaburzen Pamieci i Neuroobrazowania Affidea

Warsaw, Poland

Actively Recruiting

146

City Clinic Research Sp. z o.o.

Warsaw, Poland

Actively Recruiting

147

ETG Neuroscience Sp. z o.o.

Warsaw, Poland

Actively Recruiting

148

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Poland

Actively Recruiting

149

Hallym University Dongtan Sacred Heart Hospital - Neurology

Gyeonggi-do, South Korea

Actively Recruiting

150

Inje University Ilsan Paik Hospital - Allergology

Gyeonggi-do, South Korea

Actively Recruiting

151

Ewha Womans University Seoul Hospital - Neurology

Seoul, South Korea

Actively Recruiting

152

Kangbuk Samsung Hospital - Neurology

Seoul, South Korea

Actively Recruiting

153

Nowon Eulji Medical Center, Eulji University - Neurology

Seoul, South Korea

Actively Recruiting

154

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

155

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Actively Recruiting

156

Hospital Clinic de Barcelona - Neurología

Barcelona, Spain

Not Yet Recruiting

157

Hospital Universitario Vall d'Hebron - Enfermedades Infecciosas

Barcelona, Spain

Actively Recruiting

158

FutureMeds Spain Cádiz

Cadiz, Spain

Actively Recruiting

159

FutureMeds Madrid

Madrid, Spain

Actively Recruiting

160

Hospital Universitario Marqués de Valdecilla - Neurologia

Santander, Spain

Actively Recruiting

161

Hospital Universitario Virgen del Rocio

Seville, Spain

Actively Recruiting

162

Hospital Clinico Universitario de Valladolid - Gastroenterology

Valladolid, Spain

Actively Recruiting

163

Royal Devon And Exeter Hospital - Neurology

Exeter, United Kingdom

Not Yet Recruiting

164

Hull University Teaching Hospitals NHS Trust - Hull Royal Infirmary

Hull, United Kingdom

Not Yet Recruiting

165

Walton Centre For Neurology And Neurosurgery

Liverpool, United Kingdom

Not Yet Recruiting

166

King's College Hospital

London, United Kingdom

Not Yet Recruiting

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Research Team

I

Ipsen Clinical Study Enquiries

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

10

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