A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults

Description

The purpose of this study is to evaluate the efficacy and safety of the study drug, Corabotase (also known as IPN10200), and to assess how well it works when compared with placebo in treating Cervical Dystonia (CD) in adults. CD can cause a series of abnormalities and symptoms in the head and neck that can lead to neck pain and stiffness, and headaches. CD is believed to involve deep parts within the brain that control movement, but genetic factors, environmental factors, and abnormalities in the brain may also play a role. The usual treatment for CD includes injecting BoNT into the affected muscles, but the treatment only lasts about 3 months. Corabotase is designed to last for a longer period. The study will consist of two periods: 1. A Screening Period of up to 4 weeks (28 days) to assess whether a participant can take part in the study and requires at least one visit. 2. A Treatment Period of 36 weeks. On Day 1 of the treatment period, participants will receive either Corabotase Dose A or Dose B (additional participants may receive Corabotase Dose C) of the study drug, or placebo distributed into different muscles in the head, neck and shoulders. Participants may continue some other medications, but details need to be recorded. There will be 10 visits to the clinic in person and one remote visits (phone call) (12 visits to the clinic for participants who receive Dose C). Participants will undergo blood samplings, urine collections, physical/neurological examinations, and clinical evaluations. Participants will also need to complete questionnaires throughout the study. The total study duration for a participant will be up to 40 weeks (approximately 9 months).

Interventions

• Corabotase (Biological)
  Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
• Placebo (Other)
  Excipients without active substance will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.

Eligibility criteria

Conditions

Locations

• University of Arizona Health Sciences - Neurology — Tucson, Arizona, United States
• Parkinson's & Mvmt Disorders Inst — Fountain Valley, California, United States
• Loma Linda University School of Medicine - Neurology — Loma Linda, California, United States
• Parkinson's Ds & Mvt Disorders Cntr — Boca Raton, Florida, United States
• USF Health Byrd Alzheimer's Institute — Tampa, Florida, United States
• Emory Brain Health Center — Atlanta, Georgia, United States
• Rush Medical Center — Chicago, Illinois, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• Ichan Sch of Medicine @ Mt. Sinai — New York, New York, United States
• Kingfisher Cooperative — Spokane, Washington, United States
• Fakultni nemocnice u sv. Anny v Brne - I. Neurologicka klinika — Brno, Czechia
• MINKSneuro s.r.o. — Brno, Czechia
• NEUROHK s.r.o. — Choceň, Czechia
• Fakultni nemocnice Olomouc - Neurologicka klinika — Olomouc, Czechia
• Vseobecna fakultni nemocnice v Praze - Neurologicka klinika — Prague, Czechia
• CHU Grenoble Alpes - Site Nord - Neurology — Grenoble, France
• Timone University Hospital — Marseille, France
• CHU Nimes - Hôpital Caremeau — Nîmes, France
• Hopitaux Universitaire de Strasbourg - Hopital de Hautepierre - Neurologie — Strasbourg, France
• Centre Hospitalier Universitaire (CHU) Purpan - Institut Des Sciences du Cerveau De Toulouse (Institute for Brain Sciences) — Toulouse, France
• Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB - Neurologie — Haag in Oberbayern, Germany
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
• GFO Kliniken Troisdorf — Troisdorf, Germany
• University Hospital Tuebingen - Neurologie — Tübingen, Germany
• Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL Bologna — Bologna, Italy
• Istituto Auxologico Italiano - Auxologico San Luca — Milan, Italy
• Istituto Neurologico C. Besta — Milan, Italy
• IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione — Pavia, Italy
• Azienda USL-IRCCS di Reggio Emilia - Presidio ospedaliero provinciale sede di Reggio Emilia — Reggio Emilia, Italy
• Specjalistyczna Praktyka Lekarska Dr Stanislaw Ochudlo — Katowice, Poland
• Futuremeds Krakow — Krakow, Poland
• SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow, Poland
• Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. — Oświęcim, Poland
• Eskulap Pabianice Sp z o.o. — Pabianice, Poland
• ETG Neuroscience Sp. z o.o. — Warsaw, Poland
• Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego — Wroclaw, Poland
• Hospital de la Santa Creu i Sant Pau - Neurología — Barcelona, Spain
• H.U. Puerta del Mar - Neurocirugía — Cadiz, Spain
• Hospital Universitario De La Princesa — Madrid, Spain
• Hospital Universitario Ramon y Cajal - Neurologia — Madrid, Spain
• Hospital Universitario Virgen del Rocio - Neurofisiología Clínica — Seville, Spain
• Royal Devon And Exeter Hospital - Neurology — Exeter, United Kingdom
• The Walton Centre — Fazakerley, United Kingdom
• University College London Hospitals NHS Foundation Trust - National Hospital for Neurology and Neurosurgery — London, United Kingdom
• Luton And Dunstable Hospital - Neurology — Luton, United Kingdom