Cervical DystoniaPhase 2CATALPANCT06937931
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
A Phase 2 study testing Corabotase in people with Cervical Dystonia, run by Ipsen at 45 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Corabotase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 45 sitesin 8 countries
- Study dates
- 30 Jun 2025to 5 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
45 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
45 sites in 8 countries
United States10 sites, 8 recruiting
- Recruiting
Emory Brain Health Center
Atlanta, Georgia, 30329
- Recruiting
Parkinson's Ds & Mvt Disorders Cntr
Boca Raton, Florida, 33486
- Recruiting
Rush Medical Center
Chicago, Illinois, 60612
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
- Recruiting
Parkinson's & Mvmt Disorders Inst
Fountain Valley, California, 92708
- Withdrawn
Loma Linda University School of Medicine - Neurology
Loma Linda, California, 92354
- Recruiting
Ichan Sch of Medicine @ Mt. Sinai
New York, New York, 10029
- Recruiting
Kingfisher Cooperative
Spokane, Washington, 99201
- Not yet recruiting
USF Health Byrd Alzheimer's Institute
Tampa, Florida, 33613
- Active, not recruiting
University of Arizona Health Sciences - Neurology
Tucson, Arizona, 85724
Poland7 sites, 5 recruiting
- Withdrawn
Specjalistyczna Praktyka Lekarska Dr Stanislaw Ochudlo
Katowice
- Recruiting
Futuremeds Krakow
Krakow
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow
- Recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Oświęcim
- Recruiting
Eskulap Pabianice Sp z o.o.
Pabianice
- Recruiting
ETG Neuroscience Sp. z o.o.
Warsaw
- Withdrawn
Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego
Wroclaw
Czechia5 sites, 3 recruiting
- Recruiting
Fakultni nemocnice u sv. Anny v Brne - I. Neurologicka klinika
Brno
- Active, not recruiting
MINKSneuro s.r.o.
Brno
- Recruiting
NEUROHK s.r.o.
Choceň
- Not yet recruiting
Fakultni nemocnice Olomouc - Neurologicka klinika
Olomouc
- Withdrawn
Vseobecna fakultni nemocnice v Praze - Neurologicka klinika
Prague
France5 sites, 3 recruiting
- Recruiting
CHU Grenoble Alpes - Site Nord - Neurology
Grenoble
- Active, not recruiting
Timone University Hospital
Marseille
- Recruiting
CHU Nimes - Hôpital Caremeau
Nîmes
- Active, not recruiting
Hopitaux Universitaire de Strasbourg - Hopital de Hautepierre - Neurologie
Strasbourg
- Recruiting
Centre Hospitalier Universitaire (CHU) Purpan - Institut Des Sciences du Cerveau De Toulouse (Institute for Brain Sciences)
Toulouse
Italy5 sites, 4 recruiting
- Recruiting
Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL Bologna
Bologna
- Recruiting
Istituto Auxologico Italiano - Auxologico San Luca
Milan
- Active, not recruiting
Istituto Neurologico C. Besta
Milan
- Recruiting
IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia
- Not yet recruiting
Azienda USL-IRCCS di Reggio Emilia - Presidio ospedaliero provinciale sede di Reggio Emilia
Reggio Emilia
Spain5 sites, 3 recruiting
- Active, not recruiting
Hospital de la Santa Creu i Sant Pau - Neurología
Barcelona
- Recruiting
H.U. Puerta del Mar - Neurocirugía
Cadiz
- Recruiting
Hospital Universitario De La Princesa
Madrid
- Withdrawn
Hospital Universitario Ramon y Cajal - Neurologia
Madrid
- Recruiting
Hospital Universitario Virgen del Rocio - Neurofisiología Clínica
Seville
Germany4 sites, 3 recruiting
- Recruiting
Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB - Neurologie
Haag in Oberbayern
- Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg
- Recruiting
GFO Kliniken Troisdorf
Troisdorf
- Active, not recruiting
University Hospital Tuebingen - Neurologie
Tübingen
United Kingdom4 sites, 3 recruiting
- Not yet recruiting
Royal Devon And Exeter Hospital - Neurology
Exeter
- Recruiting
The Walton Centre
Fazakerley
- Recruiting
University College London Hospitals NHS Foundation Trust - National Hospital for Neurology and Neurosurgery
London
- Active, not recruiting
Luton And Dunstable Hospital - Neurology
Luton
About this study
Official title: 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.
Read more
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:
- 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.
- 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).
- Conditions
- Cervical Dystonia
- Being tested
- Corabotase, Placebo
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorabotaseBiological
Also called IPN10200
Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
PlaceboOther
Excipients without active substance will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Treatment Arm A | Experimental | Corabotase - Dose A Receives: Biological: Corabotase |
| Group 1: Treatment Arm B | Experimental | Corabotase - Dose B Receives: Biological: Corabotase |
| Group 1: Placebo Comparator | Placebo comparator | Placebo- Group1 Receives: Other: Placebo |
| Group 2: Treatment Arm C | Experimental | Corabotase - Dose C Receives: Biological: Corabotase |
| Group 2: Placebo Comparator | Placebo comparator | Placebo- Group 2 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 4
Secondary outcomes (20)
Change from Baseline in the TWSTRS total score at all other scheduled timepoints post injection until Week 36
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.
Measured: At all timepoints post injection until Week 36.
Change from Baseline in the TWSTRS-Pain Subscale
The TWSTRS pain subscale consists of three patient-rated items that assess the participants usual, worst and best pain from the preceding week, and the subscore has a maximum of 20.
Measured: At all timepoints post injection until Week 36.
Change from baseline in the daily Numerical Rating Scale (NRS) score
The Numeric Rating Scale (NRS) is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analogue scale in which a respondent selects a whole number (0 to 10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: Averaged over every 7-day period until the Week 4 visit
Time to onset of pain reduction
Defined as the duration from the administration of the study injection to the first recorded instance of a minimum 2-point decrease in the Numeric Rating Scale (NRS) score.
Measured: 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)
As assessed by TWSTRS total score. TWSTRS scale 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.
Measured: From randomization until Week 36
Change from Baseline in the TWSTRS-Disability Subscale
The TWSTRS disability subscale assesses the effect that Cervical Dystonia (CD) has on the participant's daily activities and the subscore has a maximum of 30 and consists of six items.
Measured: At all timepoints post injection until Week 36.
Change from Baseline in the TWSTRS-Severity Subscale
The TWSTRS severity subscale rates the maximal excursion of the torticollis (degree of tilt or rotation), elevation, range of motion, etc. This severity subscore has a maximum subtotal of 35 and consists of 11 items.
Measured: At all scheduled timepoints post injection until Week 36
Change from baseline in Clinical Global Impression of Severity score
The Clinical Global Impression of Severity (CGI-S) is a clinician rated scale that measures the severity of an illness in a participant. It is rated on a 7-point scale ranging from 1 (normal) to 7 (severely ill) in answer to a question on the mental state of the participant at the time of the assessment.
Measured: At all timepoints post injection until Week 36.
Clinical Global Impression of Change score
The Clinical Global Impression of Change (CGI-C) is a clinician rated scale that measures the clinical change in a participant. It is rated on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse) in answer to a question on the mental state of the participant at the time of the assessment.
Measured: At all timepoints post injection until Week 36.
Change from baseline in Patients' Global Impression of Severity score
The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (a single-state scale). The PGI-S is a single question asking the participant to rate how their condition is now on a scale of 1 (Normal) to 4 (Severe).
Measured: At all timepoints post injection until Week 36
Patients' Global Impression of Change score
The Patient Global Impression of Change (PGI-C) is a single-item questionnaire used to measure the participant's impression of overall change in CD, in terms of activity, limitations, symptoms, emotions, and overall quality of life, since the first dose of study intervention. The measure uses a 7-point rating scale with responses ranging from "very much improved" (3) to "very much worse" (-3). Improvement is considered as very much improved, much improved, or minimally improved.
Measured: At all timepoints post injection until Week 36
Change from Baseline in the CDIP-58 total score
The Cervical Dystonia Impact Profile (CDIP-58) is a patient-based rating scale measuring the health impact of CD and contains eight subscales measuring head and neck symptoms (6 items), pain and discomfort (5 items), sleep (4 items), upper limb activities (9 items), walking (9 items), annoyance (8 items), mood (7 items), and psychosocial functioning (10 items). The total score and each subscale score have a common range of 0 (no impact) to 100 (most impact).
Measured: At all timepoints post injection until Week 36
Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuation
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.
Measured: From baseline to Week 36.
Percentage of participants with clinically significant changes from baseline in Laboratory Parameters
Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.
Measured: At all timepoints post injection until Week 36
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Measured: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in focused neurological/physical examinations.
Measured: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings.
Measured: At all timepoints post injection until Week 36
Treatment-emergence of suicidal ideation/suicidal behaviour
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used in this study for the evaluation of suicidal ideation and behaviour.
Measured: From baseline to Week 36.
Percentage of participants with Binding antibodies to IPN10200
Measured: At all timepoints post injection until Week 36
Percentage of participants with neutralising antibodies to IPN10200
Measured: At all timepoints post injection until Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start30 Jun 2025
- Primary completion26 Mar 2027 (estimated)
- Study completion5 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937931
- Sponsor's protocol ID
- CLIN-10200-457
- Other IDs
- 2024-519248-34-00
- Acronym
- CATALPA
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06937931
- Acronym / sponsor ID
- CATALPA / CLIN-10200-457
- Conditions
- Cervical Dystonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 5 Nov 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Treatment Arm A | Experimental | Biological: CorabotaseCorabotase - Dose A |
| Group 1: Treatment Arm B | Experimental | Biological: CorabotaseCorabotase - Dose B |
| Group 1: Placebo Comparator | Placebo comparator | Other: PlaceboPlacebo- Group1 |
| Group 2: Treatment Arm C | Experimental | Biological: CorabotaseCorabotase - Dose C |
| Group 2: Placebo Comparator | Placebo comparator | Other: PlaceboPlacebo- Group 2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Treatment naïve or non-naïve to BoNT therapy for CD
Key exclusion criteria (6 listed)
- Participants presenting with a swallowing disorder of any origin which might be exacerbated by BoNT treatment, such as:
- Predominant anterocollis.
- Predominant retrocollis.
- Traumatic torticollis or tardive torticollis.
- Marked limitation on passive range of motion that suggests cervical contractures or structural abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorabotaseAlso: IPN10200Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection. | Biological | Group 1: Treatment Arm A, Group 1: Treatment Arm B, Group 2: Treatment Arm C |
| PlaceboExcipients without active substance will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection. | Other | Group 1: Placebo Comparator, Group 2: Placebo Comparator |
Primary outcome
Change from Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score
Time frame: At Week 4
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.
20 secondary outcomes
Change from Baseline in the TWSTRS total score at all other scheduled timepoints post injection until Week 36
Time frame: At all timepoints post injection until Week 36.
Change from Baseline in the TWSTRS-Pain Subscale
Time frame: At all timepoints post injection until Week 36.
Change from baseline in the daily Numerical Rating Scale (NRS) score
Time frame: Averaged over every 7-day period until the Week 4 visit
Time to onset of pain reduction
Time frame: 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)
Time frame: From randomization until Week 36
Change from Baseline in the TWSTRS-Disability Subscale
Time frame: At all timepoints post injection until Week 36.
Change from Baseline in the TWSTRS-Severity Subscale
Time frame: At all scheduled timepoints post injection until Week 36
Change from baseline in Clinical Global Impression of Severity score
Time frame: At all timepoints post injection until Week 36.
Clinical Global Impression of Change score
Time frame: At all timepoints post injection until Week 36.
Change from baseline in Patients' Global Impression of Severity score
Time frame: At all timepoints post injection until Week 36
Patients' Global Impression of Change score
Time frame: At all timepoints post injection until Week 36
Change from Baseline in the CDIP-58 total score
Time frame: At all timepoints post injection until Week 36
Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuation
Time frame: From baseline to Week 36.
Percentage of participants with clinically significant changes from baseline in Laboratory Parameters
Time frame: At all timepoints post injection until Week 36
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Time frame: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in focused neurological/physical examinations.
Time frame: At all timepoints post injection until Week 36
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings.
Time frame: At all timepoints post injection until Week 36
Treatment-emergence of suicidal ideation/suicidal behaviour
Time frame: From baseline to Week 36.
Percentage of participants with Binding antibodies to IPN10200
Time frame: At all timepoints post injection until Week 36
Percentage of participants with neutralising antibodies to IPN10200
Time frame: At all timepoints post injection until Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Related trials for Cervical Dystonia
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Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ipsen Medical Director study director
Ipsen
45 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Corabotase in people with Cervical Dystonia, run by Ipsen at 45 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Poland, Czechia, France, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ipsen Clinical Study Enquiries (See e mail, clinical.trials@ipsen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score (time frame: At Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.