Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New injection aims to loosen stiff muscles in stroke survivors

NCT ID NCT04752774

Symptom relief Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests a new medicine called IPN10200 for adults with arm muscle stiffness (spasticity) after a stroke or traumatic brain injury. The goal is to find the safest and most effective dose to reduce stiffness and improve movement. About 240 participants will receive either IPN10200, a placebo, or an existing treatment (Dysport) to compare results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 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: 1. 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. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Spasticity are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Muscle Spasticity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spasticity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    60 sites in 13 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    WITHDRAWN

    Saint Petersburg, 194223, Russia

  • ASST Spedali Civili Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Alto Ave Central Hospital

    RECRUITING

    Guimarães, 4835-044, Portugal

  • Astarta, LLC, Department of Neurology

    WITHDRAWN

    Saint Petersburg, 199226, Russia

  • Bastia Hospital Center

    NOT_YET_RECRUITING

    Bastia, 20600, France

  • Bordeaux University Hospital Center - Pellegrin Hospital Group

    NOT_YET_RECRUITING

    Bordeaux, 33076, France

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

    RECRUITING

    Miskolc, Hungary

  • Brest University Hospital Center - Morvan Hospital

    NOT_YET_RECRUITING

    Brest, 29200, France

  • Brothers of Charity Hospital Linz, Department of Neurology I

    RECRUITING

    Linz, A-4021, Austria

  • Chutoen General Medical Center, Department of Rehabilitation

    RECRUITING

    Shizuoka, Japan

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

    RECRUITING

    Krakow, 31-505, Poland

  • Clinical Research Center SP. ZOO MEDIC-R

    TERMINATED

    Poznan, 61-731, Poland

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

    RECRUITING

    Verona, 37134, Italy

  • Diagnostic Consulting Center - Convex EOOD

    RECRUITING

    Sofia, 1680, Bulgaria

  • Dongguk University Ilsan Hospital

    RECRUITING

    Goyang-si, 10326, South Korea

  • Einstein Physical Medicine and Rehabilitation at Elkins Park

    RECRUITING

    Elkins Park, Pennsylvania, 19027, United States

  • EuroMediCare Specialist Outpatient Clinics in Wroclaw

    RECRUITING

    Wroclaw, 50-220, Poland

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

    WITHDRAWN

    Krasnoyarsk, 660049, Russia

  • Fukuoka Rehabilitation Hospital

    RECRUITING

    Fukuoka, Japan

  • GFO Clinics Troisdorf, St. Johannes Sieglar

    RECRUITING

    Troisdorf, 53844, Germany

  • General University Hospital in Prague, Clinic of Neurology

    RECRUITING

    Prague, 120 00, Czechia

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

    RECRUITING

    Oświęcim, 32-600, Poland

  • Heinrich Heine University Medical Center, Department of Neurology

    TERMINATED

    Düsseldorf, 40225, Germany

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

    RECRUITING

    Sandomierz, 27-600, Poland

  • Hospital Jihlava, Department of Neurology

    RECRUITING

    Jihlava, 586 33, Czechia

  • Hospital Maritimo de Oza

    RECRUITING

    A Coruña, 15006, Spain

  • Juan Ramon Jimenez Hospital

    RECRUITING

    Huelva, 21005, Spain

  • Kansas Institute of Research

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • Kepler University Hospital GmbH, Department of Neurology and Psychiatry

    RECRUITING

    Linz, 4021, Austria

  • Linden Medical Center

    RECRUITING

    Krakow, 30-721, Poland

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

    RECRUITING

    Loures, 2674-514, Portugal

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

    RECRUITING

    Matosinhos Municipality, 4464-513, Portugal

  • Local Unit of Health in Alto Minho, EPE

    RECRUITING

    Viana do Castelo, 4904-858, Portugal

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

    WITHDRAWN

    Munich, 81377, Germany

  • Ma-Lek MS Therapy Centre

    WITHDRAWN

    Katowice, 40-571, Poland

  • Medical Center "Rusemed" EOOD

    RECRUITING

    Rousse, 7005, Bulgaria

  • Medical Center Medica Plus Ltd

    RECRUITING

    Veliko Tarnovo, 5006, Bulgaria

  • Medical University Innsbruck, Department of Neurology

    RECRUITING

    Innsbruck, 6020, Austria

  • Medical University Vienna, Department of Neurology

    WITHDRAWN

    Vienna, 1090, Austria

  • Medical and Sanitary Unit #70 of "Passazhiravtotrans"

    WITHDRAWN

    Saint Petersburg, Russia

  • Meixoeiro Hospital at Vigo University Hospital Complex

    RECRUITING

    Vigo, 36200, Spain

  • Multiprofile Hospital for Active Treatment "Heart and Brain"

    WITHDRAWN

    Pleven, 5800, Bulgaria

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

    RECRUITING

    Sofia, 1113, Bulgaria

  • N.P. Bekhtereva Research Institute of Human Brain

    WITHDRAWN

    Saint Petersburg, 197376, Russia

  • NHO Murayama Medical Center, Department of Rehabilitation

    RECRUITING

    Tokyo, Japan

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

    WITHDRAWN

    Moscow, 125367, Russia

  • Neuro-Kard Ilkowski and Partners

    RECRUITING

    Poznan, 61-853, Poland

  • Neuro-Medic

    RECRUITING

    Katowice, 40-686, Poland

  • NeuroKlinika - Private Practice Prof. Andrzej Bogucki

    WITHDRAWN

    Lodz, 90-640, Poland

  • NeuroProtect Medical Center

    WITHDRAWN

    Warsaw, 01-684, Poland

  • Petz Aladar University Teaching Hospital, Department of Neurology

    RECRUITING

    Győr, Hungary

  • Quest Research Institute

    TERMINATED

    Farmington Hills, Michigan, 48334, United States

  • Rancho Los Amigos National Rehab

    RECRUITING

    Downey, California, 90242, United States

  • Raymond-Poincare Hospital - APHP

    NOT_YET_RECRUITING

    Garches, 92380, France

  • Regional Hospital Pardubice, Clinic of Neurology

    RECRUITING

    Pardubice, 532 03, Czechia

  • Santiago de Compostela Clinical Hospital, Physical Medicine and Rehabilitation

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Semmelweis University, Rehabilitation Clinic, Rehabilitation Department of Brain Injuries

    RECRUITING

    Budapest, Hungary

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Specialist Doctor Practice

    TERMINATED

    Katowice, 40-097, Poland

  • Specialist Practises LLC

    RECRUITING

    Krakow, 30-539, Poland

  • St Wojciech - Adalbertus Hospital, Neurology Department

    RECRUITING

    Gdansk, 80-462, Poland

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

    RECRUITING

    Kisvárda, H-4600, Hungary

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

    RECRUITING

    Incheon, 21431, South Korea

  • The University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Tokushima University Hospital

    RECRUITING

    Tokushima, 770-8503, Japan

  • University Hospital "Federico II"

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • University Hospital Bonn, Clinic and Policlinic for Neurology

    RECRUITING

    Bonn, 53127, Germany

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

    RECRUITING

    Hamburg, 20246, Germany

  • University Hospital Hradec Kralove, Clinic of Neurology

    WITHDRAWN

    Hradec Králové, 500 05, Czechia

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

    TERMINATED

    Mainz, 55131, Germany

  • University Hospital Kralovske Vinohrady, Clinic of Neurology

    WITHDRAWN

    Prague, 100 34, Czechia

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

    RECRUITING

    Ostrava, 708 52, Czechia

  • University Hospital Tuebingen, Department of Neurology

    RECRUITING

    Tübingen, 72076, Germany

  • University Hospital Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • University Hospital Virgen Macarena, Physical Medicine and Rehabilitation

    RECRUITING

    Seville, 41009, Spain

  • University Hospital de La Princesa, Physical Medicine and Rehabilitation

    RECRUITING

    Madrid, 28006, Spain

  • University Medicine Goettingen, Department of Neurology

    WITHDRAWN

    Goettigen, 37075, Germany

  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS

    NOT_YET_RECRUITING

    Rome, 00168, Italy

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

    RECRUITING

    Debrecen, H-4031, Hungary

  • Wolski Hospital, Neurological Department

    WITHDRAWN

    Warsaw, 01-211, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.