NCT06937931 · Ipsen
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
(CATALPA)
What this study is about
The purpose of this study is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
BIOLOGICAL
IPN10200
Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
OTHER
Placebo
Excipients without active substance will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 2. Treatment naïve or non-naïve to BoNT therapy for CD
Exclusion criteria
- 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. 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 str
Where
- Tucson, Arizona
- Fountain Valley, California
- Boca Raton, Florida
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Farmington Hills, Michigan
- New York, New York
- Spokane, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations