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

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Azonosító

NCT06937931EU 2024-519248-34-00

A regiszteradat frissítve

2026. szeptember 8.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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).

Bevonási feltételek: 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.

Kizáró feltételek: 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.

ClinicalTrials.gov NCT06937931 · EU CTIS 2024-519248-34-00