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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04752774
Other study ID # D-FR-10200-001
Secondary ID 2020-003623-42
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 29, 2021
Est. completion date June 30, 2026

Study information

Verified date May 2024
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 209
Est. completion date June 30, 2026
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
IPN10200
Powder and solvent for solution for injection
Drug:
Placebo
Powder and solvent for solution for injection
Biological:
Dysport
Powder for solution for injection

Locations

Country Name City State
Austria Brothers of Charity Hospital Linz, Department of Neurology I Linz
Austria Kepler University Hospital GmbH, Department of Neurology and Psychiatry Linz
Austria Medical University Vienna, Department of Neurology Vienna
Bulgaria Multiprofile Hospital for Active Treatment "Heart and Brain" Pleven
Bulgaria Medical Center "Rusemed" EOOD Ruse
Bulgaria "Diagnostic Consulting Center - Convex" EOOD Sofia
Bulgaria Multiprofile Hospital for Active Treatment of Neurology and Psychiatry "Sveti Naum", Sofia, Neurological Diseases Clinic for Neurodegenerative and Peripheral Neurological Diseases Sofia
Bulgaria Medical Center Medica Plus Ltd Veliko Tarnovo
Czechia Regional Hospital Pardubice, Clinic of Neurology Pardubice
Czechia General University Hospital in Prague, Clinic of Neurology Prague
Germany University Hospital Bonn, Clinic and Policlinic for Neurology Bonn
Germany Heinrich Heine University Medical Center, Department of Neurology Duesseldorf
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 GFO Clinics Troisdorf, St. Johannes Sieglar Troisdorf
Germany University Hospital Tuebingen, Department of Neurology Tuebingen
Hungary University of Debrecen Clinical Center, Department of Medical Rehabilitation and Physical Medicine Debrecen
Hungary Petz Aladar University Teaching Hospital, Department of Neurology Gyor
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
Poland St Wojciech - Adalbertus Hospital, Neurology Department Gdansk
Poland Neuro-Medic Katowice
Poland Specialist Doctor Practice Katowice
Poland Clinical Center for Neurology Sp. z o .o. (LLC) Kraków
Poland Linden Medical Center Kraków
Poland Specialist Practises LLC Kraków
Poland Health Institute Dr n. med. Magdalena Boczarska-Jedynak Oswiecim
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 EuroMediCare Specialist Outpatient Clinics in Wroclaw Wroclaw
Spain 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
United States Rancho Los Amigos National Rehab Downey California
United States Einstein Physical Medicine and Rehabilitation at Elkins Park Elkins Park Pennsylvania
United States Quest Research Institute Farmington Hills Michigan
United States Kansas Institute of Research Overland Park Kansas

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Czechia,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence, severity and nature of treatment emergent adverse events (TEAEs). from baseline until the end of study (9 months)
Primary Incidence, severity and nature of adverse events of special interest (AESI). from baseline until the end of study (9 months)
Primary Change from baseline in vital sign parameter (blood pressure) 9 months
Primary Change from baseline in vital sign parameter (Heart rate) 9 months
Primary 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
Primary Presence of IPN10200 and BoNT-A antibodies (binding and neutralising) from baseline until the end of study (9 months)
Primary Change from baseline in physical examination findings. Number of Participants with change in physical examination findings 9 months
Secondary Change from Baseline to all post-treatment visits in Modified Ashworth scale (MAS) score in the Primary target muscle group (PTMG) MAS is a scale to assess muscle tone in the injected muscles. The muscle tone will be rated as per grading from 0 to 4, there 0 =No increase in muscle tone and 4 =Affected part(s) rigid in flexion or extension. from baseline until the end of study (9 months)
Secondary Change from Baseline to post-treatment Day 29 in MAS score in the PTMG if PD profile of IPN10200 in dose escalation indicates a peak of effect different than Day 29, the endpoint will be modified accordingly) from baseline until port-treatment Day 29
Secondary Change from Baseline in MAS score in all injected muscle Groups from baseline until the end of study (9 months)
Secondary 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)
Secondary Peak of effect - maximal decrease in the MAS score from Baseline. from baseline until the end of study (9 months)
Secondary Time to peak - time to reach the peak of effect (maximal decrease in the MAS score from Baseline). from baseline until the end of study (9 months)
Secondary Duration of effect - duration between time to onset and last timepoint with a response to Treatment. from baseline until the end of study (9 months)
Secondary Response to treatment as measured by at least one grade reduction in MAS score in the PTMG from Baseline from baseline until the end of study (9 months)
Secondary Response to treatment as measured by at least one grade reduction in MAS score in all injected muscles from Baseline from baseline until the end of study (9 months)
Secondary Physician's Global Assessment (PGA) score of overall treatment response The PGA is a 9-point scale (from -4= markedly worse to +4=markedly improved) used to assess global overall treatment response by the investigator. from baseline until the end of study (9 months)
Secondary Patient Global Impression of Change in the Spastic Clinical Pattern using specific scale (PGI-c) PGI-C is a scale to assess global impression of change in the spastic clinical pattern using a 7-point Likert scale (from -3: very much worse to +3: very much improved) by answering a specific question from baseline until the end of study (9 months)
Secondary Change from Baseline in the Disability Assessment Scale (DAS) The DAS will be used to assess the effect of upper limb spasticity on hygiene, dressing, limb position and pain. Participants will be assessed in an interview format. from baseline until the end of study (9 months)
Secondary Reduction of pain in the shoulder (adducted/rotated pattern) using the Numeric Rating Scale from baseline until the end of study (9 months)
Secondary The number and percentage of participants with presence of IPN10200 and BoNT-A antibodies and titres (binding and neutralising) At baseline
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