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
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
University of Arizona Health Sciences - Neurology
NOT_YET_RECRUITING
Tucson
California
Parkinson's & Mvmt Disorders Inst
RECRUITING
Fountain Valley
Florida
Parkinson's Ds & Mvt Disorders Cntr
ACTIVE_NOT_RECRUITING
Boca Raton
USF Health Byrd Alzheimer's Institute
NOT_YET_RECRUITING
Tampa
Georgia
Emory Brain Health Center
RECRUITING
Atlanta
Illinois
Rush Medical Center
NOT_YET_RECRUITING
Chicago
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
New York
Ichan Sch of Medicine @ Mt. Sinai
ACTIVE_NOT_RECRUITING
New York
Washington
Kingfisher Cooperative
ACTIVE_NOT_RECRUITING
Spokane
Other Locations
France
CHU Grenoble Alpes - Site Nord - Neurology
ACTIVE_NOT_RECRUITING
Grenoble
Timone University Hospital
ACTIVE_NOT_RECRUITING
Marseille
CHU Nimes - Hôpital Caremeau
NOT_YET_RECRUITING
Nîmes
Hopitaux Universitaire de Strasbourg - Hopital de Hautepierre - Neurologie
ACTIVE_NOT_RECRUITING
Strasbourg
Centre Hospitalier Universitaire (CHU) Purpan - Institut Des Sciences du Cerveau De Toulouse (Institute for Brain Sciences)
NOT_YET_RECRUITING
Toulouse
Germany
Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB - Neurologie
ACTIVE_NOT_RECRUITING
Haag In Oberbayern
Universitätsklinikum Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
GFO Kliniken Troisdorf
RECRUITING
Troisdorf
University Hospital Tuebingen - Neurologie
NOT_YET_RECRUITING
Tübingen
Italy
Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL Bologna
ACTIVE_NOT_RECRUITING
Bologna
Istituto Auxologico Italiano - Auxologico San Luca