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New treatment option for Cervical Dystonia
Official title A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
ClinicalTrials.gov ID: NCT06937931
What this study is testing
What is IPN10200?
IPN10200 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for cervical dystonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 36 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- A clinical diagnosis of isolated Cervical Dystonia (CD) (idiopathic) characterized by dystonic symptoms localised to the head, neck, and shoulder...
- (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
You likely can't join if
- 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.
See the full eligibility 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)...
- (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.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Fountain Valley, California, United States
- Boca Raton, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Farmington Hills, Michigan, United States
- New York, New York, United States
- Spokane, Washington, United States
- Brno, Czechia
- Choceň, Czechia
- Olomouc, Czechia
- Prague, Czechia
- Grenoble, France
- Marseille, France
- Nîmes, France
- Strasbourg, France
- Toulouse, France
- Haag in Oberbayern, Germany
- Hamburg, Germany
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Fountain Valley, California, United States; Boca Raton, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.