A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.

Last updated: April 30, 2025
Sponsor: Ipsen
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Sjögren-larsson Syndrome

Cerebral Palsy

Limb Spasticity

Treatment

Dysport

Placebo

IPN10200

Clinical Study ID

NCT04752774
D-FR-10200-001
2020-003623-42
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be 18 to 70 years of age inclusive (except for dose escalation mustbe 18 to 65 years of age) at the time of signing the informed consent.

  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 lastinjection of any commercialized BoNT-A or B at least 4 months prior to studyBaseline

  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 limbwhen 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°

  1. Physiotherapy, occupational therapy, splinting, use of benzodiazepine, and musclerelaxants had to be stable from at least 30 days preceding the study Baseline up tothe Month 3 visit, and whenever possible until the end of the study.

  2. In good health (i.e. absence of any uncontrolled systemic disease or othersignificant medical condition) as determined by medical history, physical andneurological examinations, clinical laboratory studies, electrocardiograms (ECGs),vital signs, and Investigator's judgment prior to randomization

  3. Male and female participants Contraceptive use by men or women should be consistentwith local regulations regarding the methods of contraception for thoseparticipating 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

Exclusion Criteria:

  1. Any medical condition (including severe dysphagia or airway disease) that mayincrease, in the opinion of the investigator, the likelihood of adverse events (AEs)related to BoNT treatment.

  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 (orother BoNTs) or any excipient used in their formulation.

  4. Clinically diagnosed significant anxiety disorder, or any other significantpsychiatric disorder (e.g. depression) that might interfere with the participant'sparticipation 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 physiotherapyinitiated more than 30 days prior to Baseline and ongoing, the therapy regimenshould be maintained at the same frequency and intensity throughout the study ifpossible or at least up to 3-months post-injection).

  8. Has received previous treatment with phenol and or alcohol in the targeted upperlimb any time before the study.

  9. Has been treated or is likely to be treated with intrathecal baclofen during the 30days prior to study Baseline or during the course of the study.

  10. Current or planned treatment with any medications that interfere either directly orindirectly with neuromuscular transmission, such as curare-like non depolarisingagents, lincosamides, polymyxins, anticholinesterases and aminoglycosideantibiotics, within 30 days prior to Baseline.

  11. Use of concomitant therapy which, in the investigator's opinion, would interferewith the evaluation of the safety or efficacy of the study intervention, includingmedications 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, significantcontracture or muscle atrophy at target joint or muscle in the past 6 months priorto Screening.

  13. Use of any experimental device within 30 days or use of any treatment with anexperimental drug within five times the documented terminal half-life of therespective drug or its metabolites or if the half-life is unknown within 30 daysprior to the start of the study (prior to Baseline) and during the conduct of thestudy.

  14. Presence of any other condition (e.g. neuromuscular disorder, muscular dystrophies,cancer cachexia, sarcopenia or other disorder that could interfere withneuromuscular function), laboratory finding or circumstance that, in the judgment ofthe investigator, might increase the risk to the participant or decrease the chanceof obtaining satisfactory data to achieve the objectives of the study.

  15. Pregnant or lactating women, or women of childbearing potential not willing topractice a highly effective form of contraception method at the beginning of thestudy, 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 ofchildbearing potential and are not willing to use condoms with spermicide throughoutstudy participation.

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Dysport
Phase: 1/2
Study Start date:
April 29, 2021
Estimated Completion Date:
October 30, 2027

Connect with a study center

  • Brothers of Charity Hospital Linz, Department of Neurology I

    Linz, A-4021
    Austria

    Site Not Available

  • Kepler University Hospital GmbH, Department of Neurology and Psychiatry

    Linz, 4021
    Austria

    Site Not Available

  • Medical University Vienna, Department of Neurology

    Vienna, 1090
    Austria

    Site Not Available

  • Multiprofile Hospital for Active Treatment "Heart and Brain"

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Medical Center "Rusemed" EOOD

    Ruse, 7005
    Bulgaria

    Site Not Available

  • "Diagnostic Consulting Center - Convex" EOOD

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry "Sveti Naum", Sofia, Neurological Diseases Clinic for Neurodegenerative and Peripheral Neurological Diseases

    Sofia, 1113
    Bulgaria

    Site Not Available

  • Medical Center Medica Plus Ltd

    Veliko Tarnovo, 5006
    Bulgaria

    Site Not Available

  • University Hospital Hradec Kralove, Clinic of Neurology

    Hradec Králové, 500 05
    Czechia

    Site Not Available

  • Regional Hospital Pardubice, Clinic of Neurology

    Pardubice, 532 03
    Czechia

    Site Not Available

  • General University Hospital in Prague, Clinic of Neurology

    Prague, 120 00
    Czechia

    Site Not Available

  • University Hospital Kralovske Vinohrady, Clinic of Neurology

    Prague, 100 34
    Czechia

    Site Not Available

  • University Hospital Bonn, Clinic and Policlinic for Neurology

    Bonn, 53127
    Germany

    Site Not Available

  • Heinrich Heine University Medical Center, Department of Neurology

    Duesseldorf, 40225
    Germany

    Site Not Available

  • University Medicine Goettingen, Department of Neurology

    Goettigen, 37075
    Germany

    Site Not Available

  • University Hospital Hamburg-Eppendorf, Clinic and Polyclinic of Neurology

    Hamburg, 20246
    Germany

    Site Not Available

  • University Hospital Johannes Gutenberg - University of Mainz, Clinic and Polyclinic of Neurology

    Mainz, 55131
    Germany

    Site Not Available

  • Ludwig Maximilians University Hospital, Campus Grosshadern, Department of Neurology

    Munich, 81377
    Germany

    Site Not Available

  • GFO Clinics Troisdorf, St. Johannes Sieglar

    Troisdorf, 53844
    Germany

    Site Not Available

  • University Hospital Tuebingen, Department of Neurology

    Tuebingen, 72076
    Germany

    Site Not Available

  • University of Debrecen Clinical Center, Department of Medical Rehabilitation and Physical Medicine

    Debrecen, H-4031
    Hungary

    Site Not Available

  • Petz Aladar University Teaching Hospital, Department of Neurology

    Győr,
    Hungary

    Site Not Available

  • Szent Damjan Greek Catholic Hospital, Department of Neurology and Stroke

    Kisvárda, H-4600
    Hungary

    Site Not Available

  • Borsod-Abauj-Zemplen County Central Hospital and University Educational Hospital, Department of Neurology

    Miskolc,
    Hungary

    Site Not Available

  • St Wojciech - Adalbertus Hospital, Neurology Department

    Gdańsk, 80-462
    Poland

    Site Not Available

  • Ma-Lek MS Therapy Centre

    Katowice, 40-571
    Poland

    Site Not Available

  • Neuro-Medic

    Katowice, 40-686
    Poland

    Site Not Available

  • Specialist Doctor Practice

    Katowice, 40-097
    Poland

    Site Not Available

  • Clinical Center for Neurology Sp. z o .o. (LLC)

    Kraków, 31-505
    Poland

    Site Not Available

  • Linden Medical Center

    Kraków, 30-721
    Poland

    Site Not Available

  • Specialist Practises LLC

    Kraków, 30-539
    Poland

    Site Not Available

  • Health Institute Dr n. med. Magdalena Boczarska-Jedynak

    Oświęcim, 32-600
    Poland

    Site Not Available

  • Clinical Research Center SP. ZOO MEDIC-R

    Poznan, 61-731
    Poland

    Site Not Available

  • Neuro-Kard Ilkowski and Partners

    Poznań, 61-853
    Poland

    Site Not Available

  • Holy Spirit Specialist Hospital in Sandomierz - Neurology Teaching Hospital, Neurology Department

    Sandomierz, 27-600
    Poland

    Site Not Available

  • AKSON Outpatient Clinic

    Szczecin, 71-520
    Poland

    Site Not Available

  • NeuroProtect Medical Center

    Warsaw, 01-684
    Poland

    Site Not Available

  • Wolski Hospital, Neurological Department

    Warsaw, 01-211
    Poland

    Site Not Available

  • EuroMediCare Specialist Outpatient Clinics in Wroclaw

    Wrocław, 50-220
    Poland

    Site Not Available

  • NeuroKlinika - Private Practice Prof. Andrzej Bogucki

    Łódź, 90-640
    Poland

    Site Not Available

  • Federal Siberian Research and Clinical Center, Department of Nervous Diseases, Traditional Medicine with Course in Postgraduate Education

    Krasnoyarsk, 660049
    Russian Federation

    Site Not Available

  • National Medical Research Center Treatment and Rehabilitation Center, Department of Neurology

    Moscow, 125367
    Russian Federation

    Site Not Available

  • "Praximed" - Diagnostic and Rehabilitation Center, Rehalibitation Department

    Saint Petersburg, 194223
    Russian Federation

    Site Not Available

  • Astarta, LLC, Department of Neurology

    Saint Petersburg, 199226
    Russian Federation

    Site Not Available

  • Medical and Sanitary Unit #70 of "Passazhiravtotrans"

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • N.P. Bekhtereva Research Institute of Human Brain

    Saint Petersburg, 197376
    Russian Federation

    Site Not Available

  • Hospital Maritimo de Oza

    A Coruña, 15006
    Spain

    Site Not Available

  • University Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • University Hospital de La Princesa, Physical Medicine and Rehabilitation

    Madrid, 28006
    Spain

    Site Not Available

  • Santiago de Compostela Clinical Hospital, Physical Medicine and Rehabilitation

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Meixoeiro Hospital at Vigo University Hospital Complex

    Vigo, 36200
    Spain

    Site Not Available

  • Rancho Los Amigos National Rehab

    Downey, California 90242
    United States

    Site Not Available

  • Kansas Institute of Research

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Einstein Physical Medicine and Rehabilitation at Elkins Park

    Elkins Park, Pennsylvania 19027
    United States

    Site Not Available

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