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Purpose

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. 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. IPN10200 is designed to last for a longer period. The study will consist of two periods: 1. 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. 2. A Treatment Period of 36 weeks. On Day 1 of the treatment period, participants will receive either IPN10200 Dose A or Dose B (additional participants may receive IPN10200 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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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

  1. 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 structural abnormality.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: Treatment Arm A 		IPN10200- Dose A
  • Biological: IPN10200
    Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Experimental
Group 1: Treatment Arm B 		IPN10200- Dose B
  • Biological: IPN10200
    Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Placebo Comparator
Group 1: Placebo Comparator 		Placebo- Group1
  • 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.
Experimental
Group 2: Treatment Arm C 		IPN10200- Dose C
  • Biological: IPN10200
    Study intervention will be administered in a single treatment cycle after randomisation (Day 1). The administration cycle consists of intramuscular injection.
Placebo Comparator
Group 2: Placebo Comparator 		Placebo- Group 2
  • 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.

Recruiting Locations

Parkinson's & Mvmt Disorders Inst
Fountain Valley, California 92708

Parkinson's Ds & Mvt Disorders Cntr
Boca Raton, Florida 33486

Emory Brain Health Center
Atlanta, Georgia 30329

Quest Research Institute
Farmington Hills, Michigan 48334

Ichan Sch of Medicine @ Mt. Sinai
New York, New York 10029

Kingfisher Cooperative
Spokane, Washington 99201

More Details

Status
Recruiting
Sponsor
Ipsen

Study Contact

Ipsen Clinical Study Enquiries
See e mail
clinical.trials@ipsen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.