Actively Recruiting
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
Led by Ipsen · Updated on 2026-05-05
240
Participants Needed
81
Research Sites
413 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to assess the safety and efficacy of increasing doses of IPN10200 with the aim to evaluate the Pharmacodynamics (PD) profile of IPN10200 and to establish the total IPN10200 doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
CONDITIONS
Official Title
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years inclusive at informed consent (18 to 65 years for dose escalation)
- Spastic hemiparesis following stroke or traumatic brain injury
- At least 6 months post-stroke or traumatic brain injury
- Never received botulinum toxin or last injection at least 4 months before study baseline
- Modified Ashworth Scale score of 2 or more in the muscle to be injected
- Eligible for a total dose of 1000 U Dysport in the upper limb when applicable
- Spasticity angle of 5 degrees or more in the muscle to be injected
- No fixed contractures as defined by specific extension angle limits on fingers, wrist, and elbow
- Stable physiotherapy, occupational therapy, splinting, benzodiazepine, and muscle relaxant use for at least 30 days before baseline up to month 3 visit
- In good health without uncontrolled systemic disease or significant medical conditions
- Agree to use contraception according to local regulations throughout the study
You will not qualify if you...
- Any medical condition that may increase risk of adverse events related to botulinum toxin treatment
- Known neuromuscular junction diseases such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
- History of hypersensitivity to study drugs or their components
- Significant anxiety, psychiatric disorders, or depression that may interfere with study participation
- Planned or likely treatment with botulinum toxin during the study
- Previous surgery for spasticity in the affected upper limb
- Started physiotherapy within 30 days prior to baseline visit
- Previous treatment with phenol or alcohol in the targeted upper limb
- Treatment with intrathecal baclofen within 30 days before or during the study
- Use of medications interfering with neuromuscular transmission within 30 days prior to baseline
- Concomitant therapies that may interfere with safety or efficacy evaluation
- Planned or recent tendon lengthening surgery, significant contracture, or muscle atrophy in the past 6 months
- Use of experimental devices or drugs within specified timeframes before the study
- Other conditions like neuromuscular disorders, muscular dystrophies, cancer cachexia, or sarcopenia that could affect safety or data quality
- Pregnant or lactating women or women unwilling to use effective contraception
- Inability to understand study procedures
- Infection at injection sites
- History of drug or alcohol abuse
- Male participants not vasectomised with female partners of childbearing potential unwilling to use condoms with spermicide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 81 locations
1
Rancho Los Amigos National Rehab
Downey, California, United States, 90242
Actively Recruiting
2
Kansas Institute of Research
Overland Park, Kansas, United States, 66211
Actively Recruiting
3
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Terminated
4
Einstein Physical Medicine and Rehabilitation at Elkins Park
Elkins Park, Pennsylvania, United States, 19027
Actively Recruiting
5
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
6
Medical University Innsbruck, Department of Neurology
Innsbruck, Austria, 6020
Actively Recruiting
7
Kepler University Hospital GmbH, Department of Neurology and Psychiatry
Linz, Austria, 4021
Actively Recruiting
8
Brothers of Charity Hospital Linz, Department of Neurology I
Linz, Austria, A-4021
Actively Recruiting
9
Medical University Vienna, Department of Neurology
Vienna, Austria, 1090
Withdrawn
10
Multiprofile Hospital for Active Treatment "Heart and Brain"
Pleven, Bulgaria, 5800
Withdrawn
11
Medical Center "Rusemed" EOOD
Rousse, Bulgaria, 7005
Actively Recruiting
12
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry "Sveti Naum", Sofia, Neurological Diseases Clinic for Neurodegenerative and Peripheral Neurological Diseases
Sofia, Bulgaria, 1113
Actively Recruiting
13
Diagnostic Consulting Center - Convex EOOD
Sofia, Bulgaria, 1680
Actively Recruiting
14
Medical Center Medica Plus Ltd
Veliko Tarnovo, Bulgaria, 5006
Actively Recruiting
15
University Hospital Hradec Kralove, Clinic of Neurology
Hradec Králové, Czechia, 500 05
Withdrawn
16
Hospital Jihlava, Department of Neurology
Jihlava, Czechia, 586 33
Actively Recruiting
17
University Hospital Ostrava, Clinic of Neurology, Center for Demyelinating diseases
Ostrava, Czechia, 708 52
Actively Recruiting
18
Regional Hospital Pardubice, Clinic of Neurology
Pardubice, Czechia, 532 03
Actively Recruiting
19
University Hospital Kralovske Vinohrady, Clinic of Neurology
Prague, Czechia, 100 34
Withdrawn
20
General University Hospital in Prague, Clinic of Neurology
Prague, Czechia, 120 00
Actively Recruiting
21
Bastia Hospital Center
Bastia, France, 20600
Not Yet Recruiting
22
Bordeaux University Hospital Center - Pellegrin Hospital Group
Bordeaux, France, 33076
Not Yet Recruiting
23
Brest University Hospital Center - Morvan Hospital
Brest, France, 29200
Not Yet Recruiting
24
Raymond-Poincare Hospital - APHP
Garches, France, 92380
Not Yet Recruiting
25
University Hospital Bonn, Clinic and Policlinic for Neurology
Bonn, Germany, 53127
Actively Recruiting
26
Heinrich Heine University Medical Center, Department of Neurology
Düsseldorf, Germany, 40225
Terminated
27
University Medicine Goettingen, Department of Neurology
Goettigen, Germany, 37075
Withdrawn
28
University Hospital Hamburg-Eppendorf, Clinic and Polyclinic of Neurology
Hamburg, Germany, 20246
Actively Recruiting
29
University Hospital Johannes Gutenberg - University of Mainz, Clinic and Polyclinic of Neurology
Mainz, Germany, 55131
Terminated
30
Ludwig Maximilians University Hospital, Campus Grosshadern, Department of Neurology
Munich, Germany, 81377
Withdrawn
31
GFO Clinics Troisdorf, St. Johannes Sieglar
Troisdorf, Germany, 53844
Actively Recruiting
32
University Hospital Tuebingen, Department of Neurology
Tübingen, Germany, 72076
Actively Recruiting
33
Semmelweis University, Rehabilitation Clinic, Rehabilitation Department of Brain Injuries
Budapest, Hungary
Actively Recruiting
34
University of Debrecen Clinical Center, Department of Medical Rehabilitation and Physical Medicine
Debrecen, Hungary, H-4031
Actively Recruiting
35
Petz Aladar University Teaching Hospital, Department of Neurology
Győr, Hungary
Actively Recruiting
36
Szent Damjan Greek Catholic Hospital, Department of Neurology and Stroke
Kisvárda, Hungary, H-4600
Actively Recruiting
37
Borsod-Abauj-Zemplen County Central Hospital and University Educational Hospital, Department of Neurology
Miskolc, Hungary
Actively Recruiting
38
ASST Spedali Civili Brescia
Brescia, Italy, 25123
Actively Recruiting
39
University Hospital "Federico II"
Naples, Italy, 80131
Not Yet Recruiting
40
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
Rome, Italy, 00168
Not Yet Recruiting
41
Clinical Research Center of Verona S.r.l. - CRC
Verona, Italy, 37134
Actively Recruiting
42
Fukuoka Rehabilitation Hospital
Fukuoka, Japan
Actively Recruiting
43
Chutoen General Medical Center, Department of Rehabilitation
Shizuoka, Japan
Actively Recruiting
44
Tokushima University Hospital
Tokushima, Japan, 770-8503
Actively Recruiting
45
NHO Murayama Medical Center, Department of Rehabilitation
Tokyo, Japan
Actively Recruiting
46
St Wojciech - Adalbertus Hospital, Neurology Department
Gdansk, Poland, 80-462
Actively Recruiting
47
Specialist Doctor Practice
Katowice, Poland, 40-097
Terminated
48
Ma-Lek MS Therapy Centre
Katowice, Poland, 40-571
Withdrawn
49
Neuro-Medic
Katowice, Poland, 40-686
Actively Recruiting
50
Specialist Practises LLC
Krakow, Poland, 30-539
Actively Recruiting
51
Linden Medical Center
Krakow, Poland, 30-721
Actively Recruiting
52
Clinical Center for Neurology Sp. z o .o. (LLC)
Krakow, Poland, 31-505
Actively Recruiting
53
NeuroKlinika - Private Practice Prof. Andrzej Bogucki
Lodz, Poland, 90-640
Withdrawn
54
Health Institute Dr n. med. Magdalena Boczarska-Jedynak
Oświęcim, Poland, 32-600
Actively Recruiting
55
Clinical Research Center SP. ZOO MEDIC-R
Poznan, Poland, 61-731
Terminated
56
Neuro-Kard Ilkowski and Partners
Poznan, Poland, 61-853
Actively Recruiting
57
Holy Spirit Specialist Hospital in Sandomierz - Neurology Teaching Hospital, Neurology Department
Sandomierz, Poland, 27-600
Actively Recruiting
58
Wolski Hospital, Neurological Department
Warsaw, Poland, 01-211
Withdrawn
59
NeuroProtect Medical Center
Warsaw, Poland, 01-684
Withdrawn
60
EuroMediCare Specialist Outpatient Clinics in Wroclaw
Wroclaw, Poland, 50-220
Actively Recruiting
61
Alto Ave Central Hospital
Guimarães, Portugal, 4835-044
Actively Recruiting
62
Local Health Unit Loures-Odivelas E.P.E.
Loures, Portugal, 2674-514
Actively Recruiting
63
Local Health Unit of Matosinhos (ULSM), EPE - Pedro Hispano Hospital
Matosinhos Municipality, Portugal, 4464-513
Actively Recruiting
64
Local Unit of Health in Alto Minho, EPE
Viana do Castelo, Portugal, 4904-858
Actively Recruiting
65
Federal Siberian Research and Clinical Center, Department of Nervous Diseases, Traditional Medicine with Course in Postgraduate Education
Krasnoyarsk, Russia, 660049
Withdrawn
66
National Medical Research Center Treatment and Rehabilitation Center, Department of Neurology
Moscow, Russia, 125367
Withdrawn
67
"Praximed" - Diagnostic and Rehabilitation Center, Rehalibitation Department
Saint Petersburg, Russia, 194223
Withdrawn
68
N.P. Bekhtereva Research Institute of Human Brain
Saint Petersburg, Russia, 197376
Withdrawn
69
Astarta, LLC, Department of Neurology
Saint Petersburg, Russia, 199226
Withdrawn
70
Medical and Sanitary Unit #70 of "Passazhiravtotrans"
Saint Petersburg, Russia
Withdrawn
71
Dongguk University Ilsan Hospital
Goyang-si, South Korea, 10326
Actively Recruiting
72
The Catholic University of Korea - Incheon St. Mary's Hospital
Incheon, South Korea, 21431
Actively Recruiting
73
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
74
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
75
Hospital Maritimo de Oza
A Coruña, Spain, 15006
Actively Recruiting
76
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
77
Juan Ramon Jimenez Hospital
Huelva, Spain, 21005
Actively Recruiting
78
University Hospital de La Princesa, Physical Medicine and Rehabilitation
Madrid, Spain, 28006
Actively Recruiting
79
Santiago de Compostela Clinical Hospital, Physical Medicine and Rehabilitation
Santiago de Compostela, Spain, 15706
Actively Recruiting
80
University Hospital Virgen Macarena, Physical Medicine and Rehabilitation
Seville, Spain, 41009
Actively Recruiting
81
Meixoeiro Hospital at Vigo University Hospital Complex
Vigo, Spain, 36200
Actively Recruiting
Research Team
I
Ipsen Recruitment Enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here