Actively Recruiting
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
Led by Ipsen · Updated on 2026-05-05
132
Participants Needed
44
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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).
CONDITIONS
Official Title
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Clinical diagnosis of isolated Cervical Dystonia (idiopathic) with symptoms in head, neck, and shoulders
- At least moderate severity of Cervical Dystonia defined by TWSTRS total score ≥ 20
- TWSTRS-Severity subscale score ≥ 15
- TWSTRS-Disability subscale score ≥ 3
- TWSTRS-Pain subscale score ≥ 1
- Participants may be either treatment-naïve or previously treated with botulinum toxin therapy for Cervical Dystonia
You will not qualify if you...
- Presence of swallowing disorder that might worsen with botulinum toxin treatment, including severe dysphagia requiring diet change
- Predominant anterocollis
- Predominant retrocollis
- Traumatic or tardive torticollis
- Significant limitation in passive neck movement suggesting contractures or structural abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
University of Arizona Health Sciences - Neurology
Tucson, Arizona, United States, 85724
Active, Not Recruiting
2
Parkinson's & Mvmt Disorders Inst
Fountain Valley, California, United States, 92708
Actively Recruiting
3
Parkinson's Ds & Mvt Disorders Cntr
Boca Raton, Florida, United States, 33486
Actively Recruiting
4
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States, 33613
Not Yet Recruiting
5
Emory Brain Health Center
Atlanta, Georgia, United States, 30329
Actively Recruiting
6
Rush Medical Center
Chicago, Illinois, United States, 60612
Active, Not Recruiting
7
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
8
Ichan Sch of Medicine @ Mt. Sinai
New York, New York, United States, 10029
Actively Recruiting
9
Kingfisher Cooperative
Spokane, Washington, United States, 99201
Actively Recruiting
10
Fakultni nemocnice u sv. Anny v Brne - I. Neurologicka klinika
Brno, Czechia
Actively Recruiting
11
MINKSneuro s.r.o.
Brno, Czechia
Active, Not Recruiting
12
NEUROHK s.r.o.
Choceň, Czechia
Actively Recruiting
13
Fakultni nemocnice Olomouc - Neurologicka klinika
Olomouc, Czechia
Not Yet Recruiting
14
Vseobecna fakultni nemocnice v Praze - Neurologicka klinika
Prague, Czechia
Withdrawn
15
CHU Grenoble Alpes - Site Nord - Neurology
Grenoble, France
Actively Recruiting
16
Timone University Hospital
Marseille, France
Active, Not Recruiting
17
CHU Nimes - Hôpital Caremeau
Nîmes, France
Actively Recruiting
18
Hopitaux Universitaire de Strasbourg - Hopital de Hautepierre - Neurologie
Strasbourg, France
Active, Not Recruiting
19
Centre Hospitalier Universitaire (CHU) Purpan - Institut Des Sciences du Cerveau De Toulouse (Institute for Brain Sciences)
Toulouse, France
Actively Recruiting
20
Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB - Neurologie
Haag in Oberbayern, Germany
Actively Recruiting
21
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Not Yet Recruiting
22
GFO Kliniken Troisdorf
Troisdorf, Germany
Actively Recruiting
23
University Hospital Tuebingen - Neurologie
Tübingen, Germany
Active, Not Recruiting
24
Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL Bologna
Bologna, Italy
Actively Recruiting
25
Istituto Auxologico Italiano - Auxologico San Luca
Milan, Italy
Actively Recruiting
26
Istituto Neurologico C. Besta
Milan, Italy
Active, Not Recruiting
27
IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, Italy
Actively Recruiting
28
Azienda USL-IRCCS di Reggio Emilia - Presidio ospedaliero provinciale sede di Reggio Emilia
Reggio Emilia, Italy
Not Yet Recruiting
29
Specjalistyczna Praktyka Lekarska Dr Stanislaw Ochudlo
Katowice, Poland
Withdrawn
30
Futuremeds Krakow
Krakow, Poland
Actively Recruiting
31
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland
Actively Recruiting
32
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Oświęcim, Poland
Actively Recruiting
33
Eskulap Pabianice Sp z o.o.
Pabianice, Poland
Actively Recruiting
34
ETG Neuroscience Sp. z o.o.
Warsaw, Poland
Actively Recruiting
35
Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego
Wroclaw, Poland
Withdrawn
36
Hospital de la Santa Creu i Sant Pau - Neurología
Barcelona, Spain
Active, Not Recruiting
37
H.U. Puerta del Mar - Neurocirugía
Cadiz, Spain
Actively Recruiting
38
Hospital Universitario De La Princesa
Madrid, Spain
Actively Recruiting
39
Hospital Universitario Ramon y Cajal - Neurologia
Madrid, Spain
Withdrawn
40
Hospital Universitario Virgen del Rocio - Neurofisiología Clínica
Seville, Spain
Actively Recruiting
41
Royal Devon And Exeter Hospital - Neurology
Exeter, United Kingdom
Not Yet Recruiting
42
The Walton Centre
Fazakerley, United Kingdom
Actively Recruiting
43
University College London Hospitals NHS Foundation Trust - National Hospital for Neurology and Neurosurgery
London, United Kingdom
Actively Recruiting
44
Luton And Dunstable Hospital - Neurology
Luton, United Kingdom
Active, Not Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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