A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults (NCT06937931)
A Phase II, Multicentre, Randomised, Double-blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IPN10200 as a Treatment for Cervical Dystonia in Adult Participants
🩺 Plain-English Summary (8th-Grade Level)
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: 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 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).
Who can join: Review the eligibility criteria below.
Location: University of Arizona Health Sciences - Neurology — Tucson, Arizona
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (44 Sites)
Showing the first 25 of 44 sites.
- University of Arizona Health Sciences - Neurology — Tucson, Arizona
- Parkinson's & Mvmt Disorders Inst — Fountain Valley, California
- Parkinson's Ds & Mvt Disorders Cntr — Boca Raton, Florida
- USF Health Byrd Alzheimer's Institute — Tampa, Florida
- Emory Brain Health Center — Atlanta, Georgia
- Rush Medical Center — Chicago, Illinois
- Quest Research Institute — Farmington Hills, Michigan
- Ichan Sch of Medicine @ Mt. Sinai — New York, New York
- Kingfisher Cooperative — Spokane, Washington
- Fakultni nemocnice u sv. Anny v Brne - I. Neurologicka klinika — Brno,
- MINKSneuro s.r.o. — Brno,
- NEUROHK s.r.o. — Choceň,
- Fakultni nemocnice Olomouc - Neurologicka klinika — Olomouc,
- Vseobecna fakultni nemocnice v Praze - Neurologicka klinika — Prague,
- CHU Grenoble Alpes - Site Nord - Neurology — Grenoble,
- Timone University Hospital — Marseille,
- CHU Nimes - Hôpital Caremeau — Nîmes,
- Hopitaux Universitaire de Strasbourg - Hopital de Hautepierre - Neurologie — Strasbourg,
- Centre Hospitalier Universitaire (CHU) Purpan - Institut Des Sciences du Cerveau De Toulouse (Institute for Brain Sciences) — Toulouse,
- Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB - Neurologie — Haag in Oberbayern,
- Universitätsklinikum Hamburg-Eppendorf — Hamburg,
- GFO Kliniken Troisdorf — Troisdorf,
- University Hospital Tuebingen - Neurologie — Tübingen,
- Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL Bologna — Bologna,
- Istituto Auxologico Italiano - Auxologico San Luca — Milan,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cervical Dystonia
- Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia — Toronto, Ontario
- Zinc as an Adjunctive Therapy for Cervical Dystonia — Gainesville, Florida
- Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia — Minneapolis, Minnesota
- Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia — Richmond, Virginia
Explore by condition: All Cervical Dystonia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.