A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
NCT ID: NCT04752774
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
240 participants
INTERVENTIONAL
2021-04-29
2027-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose escalation
One single administration of study medication (IPN10200, Dysport or placebo) will be injected in a dose-escalation manner. Dose-escalation will include several cohorts.
IPN10200
Powder and solvent for solution for injection
Placebo
Powder and solvent for solution for injection
Dysport
Powder for solution for injection
Dose ranging
Two fixed doses of IPN10200 will be administrated as a single injection into several muscle groups of the upper limb.
Participants will be randomised in the ratio of 3:3:2 (total IPN10200 dose 1: 30 participants; total IPN10200 dose 2: 30 participants; Dysport: 20 participants)
IPN10200
Powder and solvent for solution for injection
Dysport
Powder for solution for injection
Total dose
One single injection of study medication will be administered locally into several muscle groups of the upper limb.
Participants will be randomized in the ratio of 2:1 (Total IPN10200 dose: 30 participants; placebo: 15 participants, resulting in a total of 45 participants in Stage 3).
Or
Participants will be randomized in the ratio of 3:1 (IPN10200 lower dose: 30 participants; placebo: 10 participants, then IPN10200 higher dose: 30 participants; placebo: 10 participants, resulting in a total of 80 participants in Stage 3).
IPN10200
Powder and solvent for solution for injection
Placebo
Powder and solvent for solution for injection
Interventions
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IPN10200
Powder and solvent for solution for injection
Placebo
Powder and solvent for solution for injection
Dysport
Powder for solution for injection
Eligibility Criteria
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Inclusion Criteria
2. Has spastic hemiparesis following stroke or Traumatic brain injury (TBI)
3. Is at least 6 months post-stroke or TBI
4. Has never received BoNT or if previously treated, should have received their last injection of any commercialized BoNT-A or B at least 4 months prior to study Baseline
5. Has a MAS score ≥2 in the (PTMG) to be injected
6. Is eligible to receive a total recommended dose 1000 U Dysport in the upper limb when applicable.
7. Has angle of spasticity ≥5° in the PTMG to be injected.
8. Does not have any fixed contractures as defined by:
* Complete fingers extension with Angle of arrest at slow speed (Tardieu Scale) (XV1) ≥160°
* Complete wrist extension with XV1 ≥90°
* Complete elbow extension with XV1 ≥160°
9. Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and muscle relaxants had to be stable from at least 30 days preceding the study Baseline up to the Month 3 visit, and whenever possible until the end of the study.
10. In good health (i.e. absence of any uncontrolled systemic disease or other significant medical condition) as determined by medical history, physical and neurological examinations, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and Investigator's judgment prior to randomization
11. Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) or is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method (until the end of the study). The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test.
Exclusion Criteria
2. Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome, myasthenia gravis or amyotrophic lateral sclerosis etc.).
3. Has a history of hypersensitivity to the investigational medicinal products (or other BoNTs) or any excipient used in their formulation.
4. Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant's participation in the study.
5. Likely treatment with any serotype of BoNT for any condition during the study.
6. Undergone previous surgery to treat spasticity in the affected upper limb.
7. Has initiated physiotherapy within 30 days prior to Baseline (if physiotherapy initiated more than 30 days prior to Baseline and ongoing, the therapy regimen should be maintained at the same frequency and intensity throughout the study if possible or at least up to 3-months post-injection).
8. Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study.
9. Has been treated or is likely to be treated with intrathecal baclofen during the 30 days prior to study Baseline or during the course of the study.
10. Current or planned treatment with any medications that interfere either directly or indirectly with neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within 30 days prior to Baseline.
11. Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders. For patients taking vitamin K antagonists, the INR values should be controlled (between 2 and 3)
12. Currently planned or a history of tendon lengthening surgery, significant contracture or muscle atrophy at target joint or muscle in the past 6 months prior to Screening.
13. Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its metabolites or if the half-life is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study.
14. Presence of any other condition (e.g. neuromuscular disorder, muscular dystrophies, cancer cachexia, sarcopenia or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgment of the investigator, might increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
15. Pregnant or lactating women, or women of childbearing potential not willing to practice a highly effective form of contraception method at the beginning of the study, for the duration of the study and for the duration of the study
16. Inability to understand protocol procedures and requirements
17. Infection at the injection site(s)
18. A history of drug or alcohol abuse
19. Male participants who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation.
18 Years
70 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Rancho Los Amigos National Rehab
Downey, California, United States
Kansas Institute of Research
Overland Park, Kansas, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Einstein Physical Medicine and Rehabilitation at Elkins Park
Elkins Park, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Kepler University Hospital GmbH, Department of Neurology and Psychiatry
Linz, , Austria
Brothers of Charity Hospital Linz, Department of Neurology I
Linz, , Austria
Medical University Vienna, Department of Neurology
Vienna, , Austria
Multiprofile Hospital for Active Treatment "Heart and Brain"
Pleven, , Bulgaria
Medical Center "Rusemed" EOOD
Rousse, , Bulgaria
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry "Sveti Naum", Sofia, Neurological Diseases Clinic for Neurodegenerative and Peripheral Neurological Diseases
Sofia, , Bulgaria
Diagnostic Consulting Center - Convex EOOD
Sofia, , Bulgaria
Medical Center Medica Plus Ltd
Veliko Tarnovo, , Bulgaria
University Hospital Hradec Kralove, Clinic of Neurology
Hradec Králové, , Czechia
Hospital Jihlava, Department of Neurology
Jihlava, , Czechia
University Hospital Ostrava, Clinic of Neurology, Center for Demyelinating diseases
Ostrava, , Czechia
Regional Hospital Pardubice, Clinic of Neurology
Pardubice, , Czechia
University Hospital Kralovske Vinohrady, Clinic of Neurology
Prague, , Czechia
General University Hospital in Prague, Clinic of Neurology
Prague, , Czechia
University Hospital Bonn, Clinic and Policlinic for Neurology
Bonn, , Germany
Heinrich Heine University Medical Center, Department of Neurology
Düsseldorf, , Germany
University Medicine Goettingen, Department of Neurology
Goettigen, , Germany
University Hospital Hamburg-Eppendorf, Clinic and Polyclinic of Neurology
Hamburg, , Germany
University Hospital Johannes Gutenberg - University of Mainz, Clinic and Polyclinic of Neurology
Mainz, , Germany
Ludwig Maximilians University Hospital, Campus Grosshadern, Department of Neurology
Munich, , Germany
GFO Clinics Troisdorf, St. Johannes Sieglar
Troisdorf, , Germany
University Hospital Tuebingen, Department of Neurology
Tübingen, , Germany
Semmelweis University, Rehabilitation Clinic, Rehabilitation Department of Brain Injuries
Budapest, , Hungary
University of Debrecen Clinical Center, Department of Medical Rehabilitation and Physical Medicine
Debrecen, , Hungary
Petz Aladar University Teaching Hospital, Department of Neurology
Győr, , Hungary
Szent Damjan Greek Catholic Hospital, Department of Neurology and Stroke
Kisvárda, , Hungary
Borsod-Abauj-Zemplen County Central Hospital and University Educational Hospital, Department of Neurology
Miskolc, , Hungary
Fukuoka Rehabilitation Hospital
Fukuoka, , Japan
Chutoen General Medical Center, Department of Rehabilitation
Shizuoka, , Japan
NHO Murayama Medical Center, Department of Rehabilitation
Tokyo, , Japan
St Wojciech - Adalbertus Hospital, Neurology Department
Gdansk, , Poland
Specialist Doctor Practice
Katowice, , Poland
Ma-Lek MS Therapy Centre
Katowice, , Poland
Neuro-Medic
Katowice, , Poland
Specialist Practises LLC
Krakow, , Poland
Linden Medical Center
Krakow, , Poland
Clinical Center for Neurology Sp. z o .o. (LLC)
Krakow, , Poland
NeuroKlinika - Private Practice Prof. Andrzej Bogucki
Lodz, , Poland
Health Institute Dr n. med. Magdalena Boczarska-Jedynak
Oświęcim, , Poland
Clinical Research Center SP. ZOO MEDIC-R
Poznan, , Poland
Neuro-Kard Ilkowski and Partners
Poznan, , Poland
Holy Spirit Specialist Hospital in Sandomierz - Neurology Teaching Hospital, Neurology Department
Sandomierz, , Poland
Wolski Hospital, Neurological Department
Warsaw, , Poland
NeuroProtect Medical Center
Warsaw, , Poland
EuroMediCare Specialist Outpatient Clinics in Wroclaw
Wroclaw, , Poland
Federal Siberian Research and Clinical Center, Department of Nervous Diseases, Traditional Medicine with Course in Postgraduate Education
Krasnoyarsk, , Russia
National Medical Research Center Treatment and Rehabilitation Center, Department of Neurology
Moscow, , Russia
"Praximed" - Diagnostic and Rehabilitation Center, Rehalibitation Department
Saint Petersburg, , Russia
N.P. Bekhtereva Research Institute of Human Brain
Saint Petersburg, , Russia
Astarta, LLC, Department of Neurology
Saint Petersburg, , Russia
Medical and Sanitary Unit #70 of "Passazhiravtotrans"
Saint Petersburg, , Russia
Hospital Maritimo de Oza
A Coruña, , Spain
University Hospital Vall d'Hebron
Barcelona, , Spain
University Hospital de La Princesa, Physical Medicine and Rehabilitation
Madrid, , Spain
Santiago de Compostela Clinical Hospital, Physical Medicine and Rehabilitation
Santiago de Compostela, , Spain
Meixoeiro Hospital at Vigo University Hospital Complex
Vigo, , Spain
Countries
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Central Contacts
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Facility Contacts
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Specialist P LLC
Role: primary
Specialist P LLC
Role: primary
Other Identifiers
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2020-003623-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D-FR-10200-001
Identifier Type: -
Identifier Source: org_study_id
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