Phase
Condition
Sjögren-larsson Syndrome
Cerebral Palsy
Limb Spasticity
Treatment
Dysport
Placebo
IPN10200
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
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 lastinjection of any commercialized BoNT-A or B at least 4 months prior to studyBaseline
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 limbwhen 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 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.
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
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:
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.
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 (orother BoNTs) or any excipient used in their formulation.
Clinically diagnosed significant anxiety disorder, or any other significantpsychiatric disorder (e.g. depression) that might interfere with the participant'sparticipation 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 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).
Has received previous treatment with phenol and or alcohol in the targeted upperlimb any time before the study.
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.
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.
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)
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.
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.
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.
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
Inability to understand protocol procedures and requirements
Infection at the injection site(s)
A history of drug or alcohol abuse
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
Connect with a study center
Brothers of Charity Hospital Linz, Department of Neurology I
Linz, A-4021
AustriaSite Not Available
Kepler University Hospital GmbH, Department of Neurology and Psychiatry
Linz, 4021
AustriaSite Not Available
Medical University Vienna, Department of Neurology
Vienna, 1090
AustriaSite Not Available
Multiprofile Hospital for Active Treatment "Heart and Brain"
Pleven, 5800
BulgariaSite Not Available
Medical Center "Rusemed" EOOD
Ruse, 7005
BulgariaSite Not Available
"Diagnostic Consulting Center - Convex" EOOD
Sofia, 1680
BulgariaSite 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
BulgariaSite Not Available
Medical Center Medica Plus Ltd
Veliko Tarnovo, 5006
BulgariaSite Not Available
University Hospital Hradec Kralove, Clinic of Neurology
Hradec Králové, 500 05
CzechiaSite Not Available
Regional Hospital Pardubice, Clinic of Neurology
Pardubice, 532 03
CzechiaSite Not Available
General University Hospital in Prague, Clinic of Neurology
Prague, 120 00
CzechiaSite Not Available
University Hospital Kralovske Vinohrady, Clinic of Neurology
Prague, 100 34
CzechiaSite Not Available
University Hospital Bonn, Clinic and Policlinic for Neurology
Bonn, 53127
GermanySite Not Available
Heinrich Heine University Medical Center, Department of Neurology
Duesseldorf, 40225
GermanySite Not Available
University Medicine Goettingen, Department of Neurology
Goettigen, 37075
GermanySite Not Available
University Hospital Hamburg-Eppendorf, Clinic and Polyclinic of Neurology
Hamburg, 20246
GermanySite Not Available
University Hospital Johannes Gutenberg - University of Mainz, Clinic and Polyclinic of Neurology
Mainz, 55131
GermanySite Not Available
Ludwig Maximilians University Hospital, Campus Grosshadern, Department of Neurology
Munich, 81377
GermanySite Not Available
GFO Clinics Troisdorf, St. Johannes Sieglar
Troisdorf, 53844
GermanySite Not Available
University Hospital Tuebingen, Department of Neurology
Tuebingen, 72076
GermanySite Not Available
University of Debrecen Clinical Center, Department of Medical Rehabilitation and Physical Medicine
Debrecen, H-4031
HungarySite Not Available
Petz Aladar University Teaching Hospital, Department of Neurology
Győr,
HungarySite Not Available
Szent Damjan Greek Catholic Hospital, Department of Neurology and Stroke
Kisvárda, H-4600
HungarySite Not Available
Borsod-Abauj-Zemplen County Central Hospital and University Educational Hospital, Department of Neurology
Miskolc,
HungarySite Not Available
St Wojciech - Adalbertus Hospital, Neurology Department
Gdańsk, 80-462
PolandSite Not Available
Ma-Lek MS Therapy Centre
Katowice, 40-571
PolandSite Not Available
Neuro-Medic
Katowice, 40-686
PolandSite Not Available
Specialist Doctor Practice
Katowice, 40-097
PolandSite Not Available
Clinical Center for Neurology Sp. z o .o. (LLC)
Kraków, 31-505
PolandSite Not Available
Linden Medical Center
Kraków, 30-721
PolandSite Not Available
Specialist Practises LLC
Kraków, 30-539
PolandSite Not Available
Health Institute Dr n. med. Magdalena Boczarska-Jedynak
Oświęcim, 32-600
PolandSite Not Available
Clinical Research Center SP. ZOO MEDIC-R
Poznan, 61-731
PolandSite Not Available
Neuro-Kard Ilkowski and Partners
Poznań, 61-853
PolandSite Not Available
Holy Spirit Specialist Hospital in Sandomierz - Neurology Teaching Hospital, Neurology Department
Sandomierz, 27-600
PolandSite Not Available
AKSON Outpatient Clinic
Szczecin, 71-520
PolandSite Not Available
NeuroProtect Medical Center
Warsaw, 01-684
PolandSite Not Available
Wolski Hospital, Neurological Department
Warsaw, 01-211
PolandSite Not Available
EuroMediCare Specialist Outpatient Clinics in Wroclaw
Wrocław, 50-220
PolandSite Not Available
NeuroKlinika - Private Practice Prof. Andrzej Bogucki
Łódź, 90-640
PolandSite Not Available
Federal Siberian Research and Clinical Center, Department of Nervous Diseases, Traditional Medicine with Course in Postgraduate Education
Krasnoyarsk, 660049
Russian FederationSite Not Available
National Medical Research Center Treatment and Rehabilitation Center, Department of Neurology
Moscow, 125367
Russian FederationSite Not Available
"Praximed" - Diagnostic and Rehabilitation Center, Rehalibitation Department
Saint Petersburg, 194223
Russian FederationSite Not Available
Astarta, LLC, Department of Neurology
Saint Petersburg, 199226
Russian FederationSite Not Available
Medical and Sanitary Unit #70 of "Passazhiravtotrans"
Saint Petersburg,
Russian FederationSite Not Available
N.P. Bekhtereva Research Institute of Human Brain
Saint Petersburg, 197376
Russian FederationSite Not Available
Hospital Maritimo de Oza
A Coruña, 15006
SpainSite Not Available
University Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
University Hospital de La Princesa, Physical Medicine and Rehabilitation
Madrid, 28006
SpainSite Not Available
Santiago de Compostela Clinical Hospital, Physical Medicine and Rehabilitation
Santiago De Compostela, 15706
SpainSite Not Available
Meixoeiro Hospital at Vigo University Hospital Complex
Vigo, 36200
SpainSite Not Available
Rancho Los Amigos National Rehab
Downey, California 90242
United StatesSite Not Available
Kansas Institute of Research
Overland Park, Kansas 66211
United StatesSite Not Available
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
Einstein Physical Medicine and Rehabilitation at Elkins Park
Elkins Park, Pennsylvania 19027
United StatesSite Not Available
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