A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
NCT ID: NCT06937931
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
132 participants
INTERVENTIONAL
2025-06-30
2027-11-05
Brief Summary
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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. 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 IPN10200 Dose A or Dose B (additional participants may receive IPN10200 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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1: Treatment Arm A
IPN10200- Dose A
IPN10200
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 B
IPN10200- Dose B
IPN10200
Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Group 1: Placebo Comparator
Placebo- Group1
Placebo
Excipients without active substance will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Group 2: Treatment Arm C
IPN10200- Dose C
IPN10200
Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Group 2: Placebo Comparator
Placebo- Group 2
Placebo
Excipients without active substance will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Interventions
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IPN10200
Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Placebo
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
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Inclusion Criteria
* (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
2. Treatment naïve or non-naïve to BoNT therapy for CD
Exclusion Criteria
* (a) Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet.
2. Predominant anterocollis.
3. Predominant retrocollis.
4. Traumatic torticollis or tardive torticollis.
5. Marked limitation on passive range of motion that suggests cervical contractures or structural abnormality.
18 Years
80 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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University of Arizona Health Sciences - Neurology
Tucson, Arizona, United States
Parkinson's & Mvmt Disorders Inst
Fountain Valley, 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
Countries
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Central Contacts
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Other Identifiers
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CLIN-10200-457
Identifier Type: -
Identifier Source: org_study_id