Study on the Safety and Effectiveness of IPN10200 for Treating Upper Limb Spasticity in Adults After Stroke or Brain Injury

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What is this study about?

This clinical trial is focused on studying the treatment of upper limb spasticity, a condition that can occur after a stroke or traumatic brain injury. The study is testing a new medication called IPN10200, which is a type of botulinum toxin. This medication is being compared to another botulinum toxin product called Dysport, as well as a placebo. The purpose of the study is to evaluate the safety and effectiveness of IPN10200 in treating upper limb spasticity.

The study is conducted in several stages. Initially, different doses of IPN10200 are tested to find the safest and most effective dose. Participants receive a single injection of the medication, and their response is monitored. In later stages, the selected doses are further tested to confirm their safety and effectiveness. The study also includes an open-label extension period, where participants who have completed the earlier stages can continue to receive IPN10200 to assess its long-term safety and benefits.

Throughout the study, participants are closely monitored for any side effects or changes in their condition. The study aims to find the best dose of IPN10200 that provides the desired relief from spasticity while ensuring safety. This research could lead to improved treatment options for individuals experiencing upper limb spasticity after a stroke or traumatic brain injury.

1 joining the study

Upon joining the study, participants will be randomly assigned to receive either the new treatment, IPN10200, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

Participants will receive a single injection of the assigned treatment into the muscle, which is known as intramuscular use.

2 stage 1: dose escalation

In this stage, the safety and tolerability of increasing doses of IPN10200 will be assessed. Participants will be monitored for any side effects and the effectiveness of the treatment.

The goal is to select two dose levels for further investigation in the next stage.

3 stage 2: dose finding

Participants will receive one of the two doses of IPN10200 selected from Stage 1. The safety and effectiveness of these doses will be compared to a standard treatment called Dysport.

The aim is to identify the lowest dose that is both safe and effective for further study.

4 stage 3: efficacy assessment

This stage focuses on evaluating how well IPN10200 works compared to a placebo in treating upper limb spasticity.

Participants will be assessed for improvements in muscle stiffness and overall treatment response.

5 open-label extension period

Participants from Stage 3 may continue to receive IPN10200 in an open-label format, meaning both the participant and the study team will know the treatment being administered.

This period allows for the observation of long-term safety and effectiveness over multiple treatment cycles.

Who Can Join the Study?

Participant must be between 18 and 70 years old. If participating in dose escalation, the age range is 18 to 65 years.
Participant must be in good health, meaning no uncontrolled diseases or significant medical conditions, as determined by medical history and various health examinations.
Both men and women can participate. Contraceptive use must follow local regulations:
- Male participants: If their partner can become pregnant, they must use an effective method of contraception during the study.
- Female participants: Must not be pregnant or breastfeeding. They must either be unable to have children or use an acceptable contraceptive method during the study. A negative pregnancy test is required before participation.
Participant must be able to give signed informed consent, agreeing to follow the study’s requirements and restrictions.
Participant must have spastic hemiparesis (muscle stiffness on one side of the body) following a stroke or traumatic brain injury (TBI).
Participant must be at least 6 months post-stroke or TBI.
Participant must not have received BoNT (Botulinum Toxin) treatment before, or if previously treated, the last injection must have been at least 4 months before the study starts.
Participant must have a Modified Ashworth Scale (MAS) score of 2 or more in the muscle group to be injected. The MAS is a measure of muscle spasticity.
Participant must be eligible to receive a total recommended dose of 1000 units of Dysport in the upper limb, if applicable.
Participant must have an angle of spasticity of 5 degrees or more in the muscle group to be injected.
Participant must have a specific angle of arrest as measured by the Tardieu scale in the muscle groups to be injected:
- 160 degrees or more for finger flexors
- 90 degrees or more for wrist flexors
- 160 degrees or more for elbow flexors
For Stages 1 and 2, any physiotherapy, occupational therapy, splinting, or use of muscle relaxants must be stable for at least 30 days before the study starts and continue until the Month 3 visit, and if possible, until the end of the study. For Stage 3, these treatments must be stable for at least 3 months before the study starts.

Who Cannot Join the Study?

Patients who have not experienced a stroke or traumatic brain injury affecting the upper limb.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population. This term refers to groups who may be at a higher risk of harm or exploitation in a clinical trial, such as children, pregnant women, or those with cognitive impairments.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Nemocnice Pardubickeho kraje a.s.	Pardubice	Czechia
Centre Hospitalier General De Bastia	Bastia	France
Neuro-Medic Sp. z o.o.	Katowice	Poland
Hospital Jihlava	Jihlava	Czechia
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Unidade Local De Saude De Loures-Odivelas EPE	Loures	Portugal
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Medical Center Medica Plus Ltd.	Veliko Tirnovo	Bulgaria
Specjalistyczne Gabinety Sp. z o.o.	Cracow	Poland
Linden Sp. z o.o. sp.k.	Cracow	Poland
Szent Damjan Goeroegkatolikus Korhaz	Kisvarda	Hungary
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Gemeinnuetzige Gesellschaft der Franziskanerinnen zu Olpe mbH	Bonn	Germany
Hospital Universitario Juan Ramon Jimenez	Huelva	Spain
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD	Sofia	Bulgaria
University Of Debrecen	Debrecen	Hungary
Hospital Universitario Virgen Macarena	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Semmelweis University	Budapest	Hungary
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Kepler Universitaetsklinikum GmbH	Linz	Austria
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Medical Center Teodora EOOD	Ruse	Bulgaria
Unidade Local De Saude Do Alto Minho E.P.E.	Ponte De Lima	Portugal
EMC Instytut Medyczny S.A.	Wroclaw	Poland
University Hospital Ostrava	Ostrava	Czechia
Mgmaeuh Ceoate Allczibby 2mle Empv	Pleven	Bulgaria
Uzhwwhbsxg Mdhvonm Cfzyne Hyumtgefnwnjrxios	Hamburg	Germany
Hnerdesk Uqlridljxebdc Da Lj Ptsmnksn	Madrid	Spain
Cxbsucbj Hrrgvhrrpqkf Uwiiieoxmjjqj Dh Valp	Vigo	Spain
Mttxzti Cpaumn Mxaxgl 2hkg Eolh	Sofia	Bulgaria
Ssxikhx Syprzfyyvvmbpbc Dnuut Snywgkbo W Srgztzylwft	Sandomierz	Poland
Gunypppkxagnruqdt Vfrpctgdc Pkcl Adnpcq Elxiucci Oyrila Kwlcdm	Gyor	Hungary
Hcketnix Vrla dqvemfkm	Barcelona	Spain
Ilscehbv Zzhnhpl Ds Bxsbosmrewmzmbrnk	Oświęcim	Poland
Hzferdyc Uuaiufdjoaqfh dt A Cscaxg	A Coruna Galicia	Spain
Kuprlmj Dut Bzjzzupycqjf Boaolcx	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	19.02.2021
Bulgaria	Recruiting	19.02.2021
Czechia	Recruiting	19.02.2021
France	Not recruiting	19.02.2021
Germany	Recruiting	19.02.2021
Hungary	Recruiting	19.02.2021
Italy	Recruiting	19.02.2021
Poland	Recruiting	19.02.2021
Portugal	Recruiting	19.02.2021
Spain	Recruiting	19.02.2021

Trial locations

Investigated drugs:

IPN10200 is an experimental treatment being tested in this clinical trial. It is designed to help manage upper limb spasticity, which is a condition where muscles in the arm become stiff and difficult to move. The trial is exploring how safe and effective this treatment is when given in different amounts. The goal is to find the best dose that helps reduce muscle stiffness while being safe for patients to use over time.

Dysport is a medication already used to treat muscle stiffness in conditions like upper limb spasticity. It works by relaxing the muscles, making them less stiff and easier to move. In this trial, Dysport is used as a comparison to see how well the new treatment, IPN10200, works in reducing muscle stiffness and improving movement in the arms.

Upper limb spasticity after stroke or traumatic brain injury – This condition involves increased muscle tone and stiffness in the upper limbs, often occurring after a stroke or traumatic brain injury. It results from damage to the brain or spinal cord, which disrupts normal communication between the brain and muscles. As a result, muscles in the arms and hands may become tight and difficult to move. The condition can lead to difficulty with everyday tasks such as dressing, eating, and writing. Over time, if not managed, it can cause muscle shortening and joint deformities. The severity of spasticity can vary, and it may change over time, sometimes improving or worsening.

Trial ID:

2023-507202-14-00

Protocol code:

D-FR-10200-001

NCT ID:

NCT04752774

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effectiveness of IPN10200 for Treating Upper Limb Spasticity in Adults After Stroke or Brain Injury

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?