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

Официальное название

A Phase II, Multicentre, Randomised, Double-blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IPN10200 as a Treatment for Cervical Dystonia in Adult Participants

Обзор

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).

Вмешательства

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

Первичные конечные точки

• Change from Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [Срок оценки: At Week 4]

Вторичные конечные точки (12)

• Change from Baseline in the TWSTRS total score at all other scheduled timepoints post injection until Week 36 [Срок оценки: At all timepoints post injection until Week 36.]
• Change from Baseline in the TWSTRS-Pain Subscale [Срок оценки: At all timepoints post injection until Week 36.]
• Change from baseline in the daily Numerical Rating Scale (NRS) score [Срок оценки: Averaged over every 7-day period until the Week 4 visit]
• Time to onset of pain reduction [Срок оценки: From study injection to first timepoint at which at least 2-point reduction is observed in NRS score]
• Time to return of symptoms in responders (time from treatment to loss of 80% of peak treatment effect) [Срок оценки: From randomization until Week 36]
• Change from Baseline in the TWSTRS-Disability Subscale [Срок оценки: At all timepoints post injection until Week 36.]
• Change from Baseline in the TWSTRS-Severity Subscale [Срок оценки: At all scheduled timepoints post injection until Week 36]
• Change from baseline in Clinical Global Impression of Severity score [Срок оценки: At all timepoints post injection until Week 36.]
• Clinical Global Impression of Change score [Срок оценки: At all timepoints post injection until Week 36.]
• Change from baseline in Patients' Global Impression of Severity score [Срок оценки: At all timepoints post injection until Week 36]
• Patients' Global Impression of Change score [Срок оценки: At all timepoints post injection until Week 36]
• Change from Baseline in the CDIP-58 total score [Срок оценки: At all timepoints post injection until Week 36]

Критерии участия

Критерии включения

• A clinical diagnosis of isolated Cervical Dystonia (CD) (idiopathic) characterized by dystonic symptoms localised to the head, neck, and shoulder areas with at least moderate severity at Screening and Baseline (Day 1) defined as:

• (a) Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score ≥20
• (b) TWSTRS-Severity subscale score ≥15
• (c) TWSTRS-Disability subscale score ≥3
• (d) TWSTRS-Pain subscale score ≥ 1
• Treatment naïve or non-naïve to BoNT therapy for CD

Критерии исключения

• Participants presenting with a swallowing disorder of any origin which might be exacerbated by BoNT treatment, such as:

• (a) Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet.
• Predominant anterocollis.
• Predominant retrocollis.
• Traumatic torticollis or tardive torticollis.
• Marked limitation on passive range of motion that suggests cervical contractures or structural abnormality.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 9 центров

• University of Arizona Health Sciences - Neurology — Tucson
• Parkinson's & Mvmt Disorders Inst — Fountain Valley
• Parkinson's Ds & Mvt Disorders Cntr — Boca Raton
• USF Health Byrd Alzheimer's Institute — Tampa
• Emory Brain Health Center — Atlanta
• Rush Medical Center — Chicago
• Quest Research Institute — Farmington Hills
• Ichan Sch of Medicine @ Mt. Sinai — New York
• … и ещё 1 центр

Польша · 7 центров

• Specjalistyczna Praktyka Lekarska Dr Stanislaw Ochudlo — Katowice
• Futuremeds Krakow — Krakow
• SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow
• Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. — Oświęcim
• Eskulap Pabianice Sp z o.o. — Pabianice
• ETG Neuroscience Sp. z o.o. — Warsaw
• Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego — Wroclaw

Чехия · 5 центров

• Fakultni nemocnice u sv. Anny v Brne - I. Neurologicka klinika — Brno
• MINKSneuro s.r.o. — Brno
• NEUROHK s.r.o. — Choceň
• Fakultni nemocnice Olomouc - Neurologicka klinika — Olomouc
• Vseobecna fakultni nemocnice v Praze - Neurologicka klinika — Prague

Франция · 5 центров

• CHU Grenoble Alpes - Site Nord - Neurology — Grenoble
• Timone University Hospital — Marseille
• CHU Nimes - Hôpital Caremeau — Nîmes
• Hopitaux Universitaire de Strasbourg - Hopital de Hautepierre - Neurologie — Strasbourg
• Centre Hospitalier Universitaire (CHU) Purpan - Institut Des Sciences du Cerveau De Toulou — Toulouse

Италия · 5 центров

• Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL Bologna — Bologna
• Istituto Auxologico Italiano - Auxologico San Luca — Milan
• Istituto Neurologico C. Besta — Milan
• IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione — Pavia
• Azienda USL-IRCCS di Reggio Emilia - Presidio ospedaliero provinciale sede di Reggio Emili — Reggio Emilia

Испания · 5 центров

• Hospital de la Santa Creu i Sant Pau - Neurología — Barcelona
• H.U. Puerta del Mar - Neurocirugía — Cadiz
• Hospital Universitario De La Princesa — Madrid
• Hospital Universitario Ramon y Cajal - Neurologia — Madrid
• Hospital Universitario Virgen del Rocio - Neurofisiología Clínica — Seville

Германия · 4 центра

• Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB - Neurologie — Haag in Oberbayern
• Universitätsklinikum Hamburg-Eppendorf — Hamburg
• GFO Kliniken Troisdorf — Troisdorf
• University Hospital Tuebingen - Neurologie — Tübingen

Великобритания · 4 центра

• Royal Devon And Exeter Hospital - Neurology — Exeter
• The Walton Centre — Fazakerley
• University College London Hospitals NHS Foundation Trust - National Hospital for Neurology — London
• Luton And Dunstable Hospital - Neurology — Luton

Идентификаторы

NCT: NCT06937931 · CLIN-10200-457 · 2024-519248-34-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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