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

NCT06937931 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CLIN-10200-4572024-519248-34-00
• Study Type: interventional
• Target: 132
• Locations: 8 countries
• Sites: 44

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the study drug, 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. IPN10200 is designed to last for a longer period. The study will consist of two periods:

1. 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. 2.A Treatment Period of 36 weeks.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score

  The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is a rating scale for Cervical Dystonia (CD) consisting of three subscales: severity, disability and pain scales. The total score is the sum of each of the subscales, with a range of 0 to 85, where higher scores are indicative of greater impairment.

  At Week 4

Secondary Outcomes (20)

• Change from Baseline in the TWSTRS total score at all other scheduled timepoints post injection until Week 36

  At all timepoints post injection until Week 36.

• Change from Baseline in the TWSTRS-Pain Subscale

  At all timepoints post injection until Week 36.

• Change from baseline in the daily Numerical Rating Scale (NRS) score

  Averaged over every 7-day period until the Week 4 visit

• Time to onset of pain reduction

  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)

  From randomization until Week 36

Study Arms (5)

Group 1: Treatment Arm A

EXPERIMENTAL

IPN10200- Dose A

Biological: IPN10200

Group 1: Treatment Arm B

EXPERIMENTAL

IPN10200- Dose B

Biological: IPN10200

Group 1: Placebo Comparator

PLACEBO COMPARATOR

Placebo- Group1

Other: Placebo

Group 2: Treatment Arm C

EXPERIMENTAL

IPN10200- Dose C

Biological: IPN10200

Group 2: Placebo Comparator

PLACEBO COMPARATOR

Placebo- Group 2

Other: Placebo

Interventions

IPN10200 BIOLOGICAL

Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.

Group 1: Treatment Arm A; Group 1: Treatment Arm B; Group 2: Treatment Arm C

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.

Group 1: Placebo Comparator; Group 2: Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (44)

University of Arizona Health Sciences - Neurology

Tucson, Arizona, 85724, United States

ACTIVE NOT RECRUITING

Parkinson's & Mvmt Disorders Inst

Fountain Valley, California, 92708, United States

RECRUITING

Parkinson's Ds & Mvt Disorders Cntr

Boca Raton, Florida, 33486, United States

RECRUITING

USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

NOT YET RECRUITING

Emory Brain Health Center

Atlanta, Georgia, 30329, United States

RECRUITING

Rush Medical Center

Chicago, Illinois, 60612, United States

ACTIVE NOT RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Ichan Sch of Medicine @ Mt. Sinai

New York, New York, 10029, United States

RECRUITING

Kingfisher Cooperative

Spokane, Washington, 99201, United States

RECRUITING

Fakultni nemocnice u sv. Anny v Brne - I. Neurologicka klinika

Brno, Czechia

RECRUITING

MINKSneuro s.r.o.

Brno, Czechia

ACTIVE NOT RECRUITING

NEUROHK s.r.o.

Choceň, Czechia

RECRUITING

Fakultni nemocnice Olomouc - Neurologicka klinika

Olomouc, Czechia

NOT YET RECRUITING

Vseobecna fakultni nemocnice v Praze - Neurologicka klinika

Prague, Czechia

WITHDRAWN

CHU Grenoble Alpes - Site Nord - Neurology

Grenoble, France

RECRUITING

Timone University Hospital

Marseille, France

ACTIVE NOT RECRUITING

CHU Nimes - Hôpital Caremeau

Nîmes, France

RECRUITING

Hopitaux Universitaire de Strasbourg - Hopital de Hautepierre - Neurologie

Strasbourg, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire (CHU) Purpan - Institut Des Sciences du Cerveau De Toulouse (Institute for Brain Sciences)

Toulouse, France

RECRUITING

Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB - Neurologie

Haag in Oberbayern, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

NOT YET RECRUITING

GFO Kliniken Troisdorf

Troisdorf, Germany

RECRUITING

University Hospital Tuebingen - Neurologie

Tübingen, Germany

ACTIVE NOT RECRUITING

Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL Bologna

Bologna, Italy

RECRUITING

Istituto Auxologico Italiano - Auxologico San Luca

Milan, Italy

RECRUITING

Istituto Neurologico C. Besta

Milan, Italy

ACTIVE NOT RECRUITING

IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione

Pavia, Italy

RECRUITING

Azienda USL-IRCCS di Reggio Emilia - Presidio ospedaliero provinciale sede di Reggio Emilia

Reggio Emilia, Italy

NOT YET RECRUITING

Specjalistyczna Praktyka Lekarska Dr Stanislaw Ochudlo

Katowice, Poland

WITHDRAWN

Futuremeds Krakow

Krakow, Poland

RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland

RECRUITING

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.

Oświęcim, Poland

RECRUITING

Eskulap Pabianice Sp z o.o.

Pabianice, Poland

RECRUITING

ETG Neuroscience Sp. z o.o.

Warsaw, Poland

RECRUITING

Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego

Wroclaw, Poland

WITHDRAWN

Hospital de la Santa Creu i Sant Pau - Neurología

Barcelona, Spain

ACTIVE NOT RECRUITING

H.U. Puerta del Mar - Neurocirugía

Cadiz, Spain

RECRUITING

Hospital Universitario De La Princesa

Madrid, Spain

RECRUITING

Hospital Universitario Ramon y Cajal - Neurologia

Madrid, Spain

WITHDRAWN

Hospital Universitario Virgen del Rocio - Neurofisiología Clínica

Seville, Spain

RECRUITING

Royal Devon And Exeter Hospital - Neurology

Exeter, United Kingdom

NOT YET RECRUITING

The Walton Centre

Fazakerley, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust - National Hospital for Neurology and Neurosurgery

London, United Kingdom

RECRUITING

Luton And Dunstable Hospital - Neurology

Luton, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Central Study Contacts

Ipsen Clinical Study Enquiries

CONTACT

See e mail; clinical.trials@ipsen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): November 5, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Locations

PL (7); FR (5); ES (5); IT (5); DE (4); GB (4); CZ (5); US (9)