A study of IPN10200 for the treatment of cervical dystonia in adults
- Conditions
- Cervical Dystonia
- Registration Number
- 2024-519248-34-00
- Lead Sponsor
- Ipsen Innovation
- Brief Summary
To assess the efficacy of IPN10200 treatment compared to placebo in reducing Cervical Dystonia (CD) symptoms at Week 4 in adult participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 91
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score. [Time frame: at week 4] Change from Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score. [Time frame: at week 4]
- Secondary Outcome Measures
Name Time Method 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 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. 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 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 [Time Frame: Averaged over every 7-day period until the Week 4 visit] 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 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 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) [Time Frame: From randomization until Week 36] 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. 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-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 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 (CGI-S) score. [Time Frame: At all timepoints post injection until Week 36.] Change from baseline in Clinical Global Impression of Severity (CGI-S) score. [Time Frame: At all timepoints post injection until Week 36.]
Clinical Global Impression of Change (CGI-C) score [Time Frame: At all timepoints post injection until Week 36.] Clinical Global Impression of Change (CGI-C) score [Time Frame: At all timepoints post injection until Week 36.]
Change from baseline in Patients' Global Impression of Severity (PGI-S) score [Time Frame: At all timepoints post injection until Week 36] Change from baseline in Patients' Global Impression of Severity (PGI-S) score [Time Frame: At all timepoints post injection until Week 36]
Patients' Global Impression of Change (PGI-S) score [Time Frame: At all timepoints post injection until Week 36] Patients' Global Impression of Change (PGI-S) score [Time Frame: At all timepoints post injection until Week 36]
Change from Baseline in the Cervical Dystonia Impact Profile (CDIP-58) total score. [Time Frame: At all timepoints post injection until Week 36] Change from Baseline in the Cervical Dystonia Impact Profile (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 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 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 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 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 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] 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.] 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 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] Percentage of participants with neutralising antibodies to IPN10200. [Time Frame: At all timepoints post injection until Week 36]
Trial Locations
- Locations (31)
Fakultni Nemocnice U Sv Anny V Brne
🇨🇿Brno-Stred, Czechia
Neurohk s.r.o.
🇨🇿Chocen, Czechia
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Vseobecna Fakultni Nemocnice V Praze
🇨🇿Prague, Czechia
Neurologie a rehabilitace Skopalíkova TERAneuro s.r.o.
🇨🇿Chocen, Czechia
Centre Hospitalier Regional De Marseille
🇫🇷Marseille, France
Les Hopitaux Universitaires De Strasbourg
🇫🇷Strasbourg Cedex 2, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷Grenoble Cedex 9, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷Toulouse, France
Centre Hospitalier Universitaire De Nimes
🇫🇷Nimes Cedex 9, France
Scroll for more (21 remaining)Fakultni Nemocnice U Sv Anny V Brne🇨🇿Brno-Stred, CzechiaMarek BalazSite contact420777206135marek.balaz@fnusa.cz