A Phase 2 interventional study of Corabotase and Placebo in Cervical Dystonia, sponsored by Ipsen. Recruiting at 45 sites in 8 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ipsen · Phase 2, Interventional, and Treatment
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:
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).
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:
Exclusion Criteria:
Participants presenting with a swallowing disorder of any origin which might be exacerbated by BoNT treatment, such as:
Corabotase - Dose A
Biological: Corabotase
Corabotase - Dose B
Biological: Corabotase
Placebo- Group1
Other: Placebo
Corabotase - Dose C
Biological: Corabotase
Placebo- Group 2
Other: Placebo
Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Also known as: IPN10200
Excipients without active substance will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
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.
Time frame: At Week 4
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.
Time frame: 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.
Time frame: 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").
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
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
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.
Time frame: 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.
Time frame: 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.
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
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used in this study for the evaluation of suicidal ideation and 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
Plan to share: 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.
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