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

NCT04752774 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: D-FR-10200-0012020-003623-42
• Study Type: interventional
• Target: 240
• Locations: 14 countries
• Sites: 81

Brief 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.

Conditions

Spasticity

Keywords

Upper limb spasticity after stroke or traumatic brain injury

Outcome Measures

Primary Outcomes (7)

• Percentage of participants with treatment emergent adverse events (TEAEs).

  An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  From baseline until the end of study (9 months)

• Percentage of participants with adverse events of special interest (AESI).

  From baseline until the end of study (9 months)

• Change from baseline in vital sign parameter (blood pressure)

  9 months

• Change from baseline in vital sign parameter (Heart rate)

  9 months

• Change from baseline in clinical laboratory test results.

  Number and percentage of participants with low, normal or high values and normal or abnormal examinations will be presented.

  9 months

• Presence of IPN10200 and BoNT-A antibodies (binding and neutralising)

  From baseline until the end of study (9 months)

• Change from baseline in physical examination findings.

  Number of Participants with change in physical examination findings

  9 months

Secondary Outcomes (14)

• Change from Baseline to all post-treatment visits in Modified Ashworth scale (MAS) score in the Primary target muscle group (PTMG)

  from baseline until the end of study (9 months)

• Change from Baseline to post-treatment Day 29 in MAS score in the PTMG.

  From baseline until post-treatment Day 29

• Change from Baseline in MAS score in all injected muscle Groups

  From baseline until the end of study (9 months)

• Time to onset - time to the response to treatment (a reduction of at least one grade in the MAS score).

  From baseline until the end of study (9 months)

• Peak of effect - maximal decrease in the MAS score from Baseline.

  From baseline until the end of study (9 months)

Study Arms (3)

Dose escalation

EXPERIMENTAL

One single administration of study medication (IPN10200, Dysport or placebo) will be injected in a dose-escalation manner. Dose-escalation will include several cohorts.

Biological: IPN10200; Drug: Placebo; Biological: Dysport

Dose ranging

EXPERIMENTAL

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)

Biological: IPN10200; Biological: Dysport

Total dose

EXPERIMENTAL

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).

Biological: IPN10200; Drug: Placebo

Interventions

IPN10200 BIOLOGICAL

Powder and solvent for solution for injection

Dose escalation; Dose ranging; Total dose

Placebo DRUG

Powder and solvent for solution for injection

Dose escalation; Total dose

Dysport BIOLOGICAL

Powder for solution for injection

Dose escalation; Dose ranging

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 to 70 years of age inclusive (except for dose escalation must be 18 to 65 years of age) at the time of signing the informed consent.
• Has spastic hemiparesis following stroke or Traumatic brain injury (TBI)
• Is at least 6 months post-stroke or TBI
• 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
• Has a MAS score ≥2 in the (PTMG) to be injected
• Is eligible to receive a total recommended dose 1000 U Dysport in the upper limb when applicable.
• Has angle of spasticity ≥5° in the PTMG to be injected.
• 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°
• 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.
• 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
• 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.

You may not qualify if:

• Any medical condition (including severe dysphagia or airway disease) that may increase, in the opinion of the investigator, the likelihood of adverse events (AEs) related to BoNT treatment.
• Known disease of the neuromuscular junction (e.g. Lambert-Eaton myasthenic syndrome, myasthenia gravis or amyotrophic lateral sclerosis etc.).
• Has a history of hypersensitivity to the investigational medicinal products (or other BoNTs) or any excipient used in their formulation.
• 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.
• Likely treatment with any serotype of BoNT for any condition during the study.
• Undergone previous surgery to treat spasticity in the affected upper limb.
• 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).
• Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study.
• 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.
• 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.
• 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)
• 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.
• 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.
• 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.
• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (81)

Rancho Los Amigos National Rehab

Downey, California, 90242, United States

RECRUITING

Kansas Institute of Research

Overland Park, Kansas, 66211, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

TERMINATED

Einstein Physical Medicine and Rehabilitation at Elkins Park

Elkins Park, Pennsylvania, 19027, United States

RECRUITING

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Medical University Innsbruck, Department of Neurology

Innsbruck, 6020, Austria

RECRUITING

Kepler University Hospital GmbH, Department of Neurology and Psychiatry

Linz, 4021, Austria

RECRUITING

Brothers of Charity Hospital Linz, Department of Neurology I

Linz, A-4021, Austria

RECRUITING

Medical University Vienna, Department of Neurology

Vienna, 1090, Austria

WITHDRAWN

Multiprofile Hospital for Active Treatment "Heart and Brain"

Pleven, 5800, Bulgaria

WITHDRAWN

Medical Center "Rusemed" EOOD

Rousse, 7005, Bulgaria

RECRUITING

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

Sofia, 1113, Bulgaria

RECRUITING

Diagnostic Consulting Center - Convex EOOD

Sofia, 1680, Bulgaria

RECRUITING

Medical Center Medica Plus Ltd

Veliko Tarnovo, 5006, Bulgaria

RECRUITING

University Hospital Hradec Kralove, Clinic of Neurology

Hradec Králové, 500 05, Czechia

WITHDRAWN

Hospital Jihlava, Department of Neurology

Jihlava, 586 33, Czechia

RECRUITING

University Hospital Ostrava, Clinic of Neurology, Center for Demyelinating diseases

Ostrava, 708 52, Czechia

RECRUITING

Regional Hospital Pardubice, Clinic of Neurology

Pardubice, 532 03, Czechia

RECRUITING

University Hospital Kralovske Vinohrady, Clinic of Neurology

Prague, 100 34, Czechia

WITHDRAWN

General University Hospital in Prague, Clinic of Neurology

Prague, 120 00, Czechia

RECRUITING

Bastia Hospital Center

Bastia, 20600, France

NOT YET RECRUITING

Bordeaux University Hospital Center - Pellegrin Hospital Group

Bordeaux, 33076, France

NOT YET RECRUITING

Brest University Hospital Center - Morvan Hospital

Brest, 29200, France

NOT YET RECRUITING

Raymond-Poincare Hospital - APHP

Garches, 92380, France

NOT YET RECRUITING

University Hospital Bonn, Clinic and Policlinic for Neurology

Bonn, 53127, Germany

RECRUITING

Heinrich Heine University Medical Center, Department of Neurology

Düsseldorf, 40225, Germany

TERMINATED

University Medicine Goettingen, Department of Neurology

Goettigen, 37075, Germany

WITHDRAWN

University Hospital Hamburg-Eppendorf, Clinic and Polyclinic of Neurology

Hamburg, 20246, Germany

RECRUITING

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

Mainz, 55131, Germany

TERMINATED

Ludwig Maximilians University Hospital, Campus Grosshadern, Department of Neurology

Munich, 81377, Germany

WITHDRAWN

GFO Clinics Troisdorf, St. Johannes Sieglar

Troisdorf, 53844, Germany

RECRUITING

University Hospital Tuebingen, Department of Neurology

Tübingen, 72076, Germany

RECRUITING

Semmelweis University, Rehabilitation Clinic, Rehabilitation Department of Brain Injuries

Budapest, Hungary

RECRUITING

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

Debrecen, H-4031, Hungary

RECRUITING

Petz Aladar University Teaching Hospital, Department of Neurology

Győr, Hungary

RECRUITING

Szent Damjan Greek Catholic Hospital, Department of Neurology and Stroke

Kisvárda, H-4600, Hungary

RECRUITING

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

Miskolc, Hungary

RECRUITING

ASST Spedali Civili Brescia

Brescia, 25123, Italy

RECRUITING

University Hospital "Federico II"

Naples, 80131, Italy

NOT YET RECRUITING

University Polyclinic Foundation "Agostino Gemelli" - IRCCS

Rome, 00168, Italy

NOT YET RECRUITING

Clinical Research Center of Verona S.r.l. - CRC

Verona, 37134, Italy

RECRUITING

Fukuoka Rehabilitation Hospital

Fukuoka, Japan

RECRUITING

Chutoen General Medical Center, Department of Rehabilitation

Shizuoka, Japan

RECRUITING

Tokushima University Hospital

Tokushima, 770-8503, Japan

RECRUITING

NHO Murayama Medical Center, Department of Rehabilitation

Tokyo, Japan

RECRUITING

St Wojciech - Adalbertus Hospital, Neurology Department

Gdansk, 80-462, Poland

RECRUITING

Specialist Doctor Practice

Katowice, 40-097, Poland

TERMINATED

Ma-Lek MS Therapy Centre

Katowice, 40-571, Poland

WITHDRAWN

Neuro-Medic

Katowice, 40-686, Poland

RECRUITING

Specialist Practises LLC

Krakow, 30-539, Poland

RECRUITING

Linden Medical Center

Krakow, 30-721, Poland

RECRUITING

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

Krakow, 31-505, Poland

RECRUITING

NeuroKlinika - Private Practice Prof. Andrzej Bogucki

Lodz, 90-640, Poland

WITHDRAWN

Health Institute Dr n. med. Magdalena Boczarska-Jedynak

Oświęcim, 32-600, Poland

RECRUITING

Clinical Research Center SP. ZOO MEDIC-R

Poznan, 61-731, Poland

TERMINATED

Neuro-Kard Ilkowski and Partners

Poznan, 61-853, Poland

RECRUITING

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

Sandomierz, 27-600, Poland

RECRUITING

Wolski Hospital, Neurological Department

Warsaw, 01-211, Poland

WITHDRAWN

NeuroProtect Medical Center

Warsaw, 01-684, Poland

WITHDRAWN

EuroMediCare Specialist Outpatient Clinics in Wroclaw

Wroclaw, 50-220, Poland

RECRUITING

Alto Ave Central Hospital

Guimarães, 4835-044, Portugal

RECRUITING

Local Health Unit Loures-Odivelas E.P.E.

Loures, 2674-514, Portugal

RECRUITING

Local Health Unit of Matosinhos (ULSM), EPE - Pedro Hispano Hospital

Matosinhos Municipality, 4464-513, Portugal

RECRUITING

Local Unit of Health in Alto Minho, EPE

Viana do Castelo, 4904-858, Portugal

RECRUITING

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

Krasnoyarsk, 660049, Russia

WITHDRAWN

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

Moscow, 125367, Russia

WITHDRAWN

"Praximed" - Diagnostic and Rehabilitation Center, Rehalibitation Department

Saint Petersburg, 194223, Russia

WITHDRAWN

N.P. Bekhtereva Research Institute of Human Brain

Saint Petersburg, 197376, Russia

WITHDRAWN

Astarta, LLC, Department of Neurology

Saint Petersburg, 199226, Russia

WITHDRAWN

Medical and Sanitary Unit #70 of "Passazhiravtotrans"

Saint Petersburg, Russia

WITHDRAWN

Dongguk University Ilsan Hospital

Goyang-si, 10326, South Korea

RECRUITING

The Catholic University of Korea - Incheon St. Mary's Hospital

Incheon, 21431, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Hospital Maritimo de Oza

A Coruña, 15006, Spain

RECRUITING

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Juan Ramon Jimenez Hospital

Huelva, 21005, Spain

RECRUITING

University Hospital de La Princesa, Physical Medicine and Rehabilitation

Madrid, 28006, Spain

RECRUITING

Santiago de Compostela Clinical Hospital, Physical Medicine and Rehabilitation

Santiago de Compostela, 15706, Spain

RECRUITING

University Hospital Virgen Macarena, Physical Medicine and Rehabilitation

Seville, 41009, Spain

RECRUITING

Meixoeiro Hospital at Vigo University Hospital Complex

Vigo, 36200, Spain

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity; Brain Injuries, Traumatic

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Central Study Contacts

Ipsen Recruitment Enquiries

CONTACT

see email; clinical.trials@ipsen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 12, 2021
• Study Start: April 29, 2021
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

ES (7); JP (4); PT (4); RU (6); KR (4); DE (8); FR (4); HU (5); CZ (6); US (5); AU (4); BU (5); IT (4); PL (15)