An Integrated Phase I/II, Multicentre, Double-blind, Randomised, Dysport and Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatment of Adult Upper Limb Spasticity.

Who is this study for? Patients with Spasticity
What treatments are being studied? IPN10200
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

∙ 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.

Locations
United States
California
Rancho Los Amigos National Rehab
ACTIVE_NOT_RECRUITING
Downey
Kansas
Kansas Institute of Research
ACTIVE_NOT_RECRUITING
Overland Park
Michigan
Quest Research Institute
ACTIVE_NOT_RECRUITING
Farmington Hills
Pennsylvania
Einstein Physical Medicine and Rehabilitation at Elkins Park
ACTIVE_NOT_RECRUITING
Elkins Park
Other Locations
Austria
Brothers of Charity Hospital Linz, Department of Neurology I
ACTIVE_NOT_RECRUITING
Linz
Kepler University Hospital GmbH, Department of Neurology and Psychiatry
ACTIVE_NOT_RECRUITING
Linz
Medical University Vienna, Department of Neurology
WITHDRAWN
Vienna
Bulgaria
Multiprofile Hospital for Active Treatment Heart and Brain
ACTIVE_NOT_RECRUITING
Pleven
Medical Center Rusemed EOOD
RECRUITING
Rousse
Diagnostic Consulting Center - Convex EOOD
ACTIVE_NOT_RECRUITING
Sofia
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sveti Naum, Sofia, Neurological Diseases Clinic for Neurodegenerative and Peripheral Neurological Diseases
ACTIVE_NOT_RECRUITING
Sofia
Medical Center Medica Plus Ltd
ACTIVE_NOT_RECRUITING
Veliko Tarnovo
Germany
University Hospital Bonn, Clinic and Policlinic for Neurology
ACTIVE_NOT_RECRUITING
Bonn
Heinrich Heine University Medical Center, Department of Neurology
TERMINATED
Düsseldorf
University Medicine Goettingen, Department of Neurology
WITHDRAWN
Goettigen
University Hospital Hamburg-Eppendorf, Clinic and Polyclinic of Neurology
ACTIVE_NOT_RECRUITING
Hamburg
University Hospital Johannes Gutenberg - University of Mainz, Clinic and Polyclinic of Neurology
TERMINATED
Mainz
Ludwig Maximilians University Hospital, Campus Grosshadern, Department of Neurology
WITHDRAWN
Munich
GFO Clinics Troisdorf, St. Johannes Sieglar
ACTIVE_NOT_RECRUITING
Troisdorf
University Hospital Tuebingen, Department of Neurology
ACTIVE_NOT_RECRUITING
Tübingen
Hungary
Semmelweis University, Rehabilitation Clinic, Rehabilitation Department of Brain Injuries
NOT_YET_RECRUITING
Budapest
University of Debrecen Clinical Center, Department of Medical Rehabilitation and Physical Medicine
ACTIVE_NOT_RECRUITING
Debrecen
Petz Aladar University Teaching Hospital, Department of Neurology
ACTIVE_NOT_RECRUITING
Győr
Szent Damjan Greek Catholic Hospital, Department of Neurology and Stroke
ACTIVE_NOT_RECRUITING
Kisvárda
Borsod-Abauj-Zemplen County Central Hospital and University Educational Hospital, Department of Neurology
ACTIVE_NOT_RECRUITING
Miskolc
Poland
St Wojciech - Adalbertus Hospital, Neurology Department
ACTIVE_NOT_RECRUITING
Gdansk
Ma-Lek MS Therapy Centre
WITHDRAWN
Katowice
Neuro-Medic
ACTIVE_NOT_RECRUITING
Katowice
Specialist Doctor Practice
TERMINATED
Katowice
Clinical Center for Neurology Sp. z o .o. (LLC)
ACTIVE_NOT_RECRUITING
Krakow
Linden Medical Center
ACTIVE_NOT_RECRUITING
Krakow
Specialist Practises LLC
RECRUITING
Krakow
NeuroKlinika - Private Practice Prof. Andrzej Bogucki
WITHDRAWN
Lodz
Health Institute Dr n. med. Magdalena Boczarska-Jedynak
ACTIVE_NOT_RECRUITING
Oświęcim
Clinical Research Center SP. ZOO MEDIC-R
TERMINATED
Poznan
Neuro-Kard Ilkowski and Partners
ACTIVE_NOT_RECRUITING
Poznan
Holy Spirit Specialist Hospital in Sandomierz - Neurology Teaching Hospital, Neurology Department
ACTIVE_NOT_RECRUITING
Sandomierz
NeuroProtect Medical Center
WITHDRAWN
Warsaw
Wolski Hospital, Neurological Department
WITHDRAWN
Warsaw
EuroMediCare Specialist Outpatient Clinics in Wroclaw
RECRUITING
Wroclaw
Russian Federation
Federal Siberian Research and Clinical Center, Department of Nervous Diseases, Traditional Medicine with Course in Postgraduate Education
WITHDRAWN
Krasnoyarsk
National Medical Research Center Treatment and Rehabilitation Center, Department of Neurology
WITHDRAWN
Moscow
Astarta, LLC, Department of Neurology
WITHDRAWN
Saint Petersburg
Medical and Sanitary Unit #70 of Passazhiravtotrans
WITHDRAWN
Saint Petersburg
N.P. Bekhtereva Research Institute of Human Brain
WITHDRAWN
Saint Petersburg
Praximed - Diagnostic and Rehabilitation Center, Rehalibitation Department
WITHDRAWN
Saint Petersburg
Spain
Hospital Maritimo de Oza
ACTIVE_NOT_RECRUITING
A Coruña
University Hospital Vall d'Hebron
ACTIVE_NOT_RECRUITING
Barcelona
University Hospital de La Princesa, Physical Medicine and Rehabilitation
ACTIVE_NOT_RECRUITING
Madrid
Santiago de Compostela Clinical Hospital, Physical Medicine and Rehabilitation
ACTIVE_NOT_RECRUITING
Santiago De Compostela
Meixoeiro Hospital at Vigo University Hospital Complex
ACTIVE_NOT_RECRUITING
Vigo
Contact Information
Primary
Ipsen Recruitment Enquiries
clinical.trials@ipsen.com
see email
Time Frame
Start Date: 2021-04-29
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 240
Treatments
Experimental: Dose escalation
One single administration of study medication (IPN10200, Dysport or placebo) will be injected in a dose-escalation manner. Dose-escalation will include several cohorts.
Experimental: Dose ranging
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)
Experimental: Total dose
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).
Related Therapeutic Areas
Sponsors
Leads: Ipsen

This content was sourced from clinicaltrials.gov