Clinical trial NCT01753310: Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
Official title: A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Dystonia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
* TWSTRS total score≥ 20; TWSTRS-severity subscale score\> 10;

Exclusion Criteria:

* In apparent remission from Cervical Dystonia
* Diagnosis of pure retrocollis or pure anterocollis
* For non-naïve subjects, previous poor response to either of the last two Botox treatments
* Known requirement of \<100U or \>200U of Botox injected into the neck muscles

Primary outcomes:
measure: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
timeFrame: 4 weeks post-treatment
Secondary outcomes:
measure: Change From Baseline in TWSTRS Total Score at Week 2.
timeFrame: 2 weeks post-treatment
measure: Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.
timeFrame: 2 weeks post-treatment
measure: TWSTRS Responders at Week 2.
timeFrame: 2 weeks post-treatment
measure: Change From Baseline in CGIC in CD at Week 4.
timeFrame: 4 weeks post-treatment
measure: TWSTRS Responders at Week 4.
timeFrame: 4 weeks post-treatment
measure: Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.
timeFrame: 4 weeks post-treatment
measure: Change From Baseline in CDIP-58 Total Score at Week 2.
timeFrame: 2 weeks post-treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Movement Disorders Center of Arizona, LLC
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Berkeley
country: United States
facility: East Bay Physician's Group
state: California
city: Fountain Valley
country: United States
facility: Parkinson's and Movement Disorder Institute
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Healthcare, Department of Neurology
state: California
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado at Denver Health Sciences
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: Parkinson's & Movement Disorders Center of Boca Raton
state: Florida
city: Gainesville
country: United States
facility: University of Florida Center for Movement Disorders and Neurorestoration
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Center for Neurological Disorders
state: Florida
city: Port Charlotte
country: United States
facility: PD Treatment Center of SW FL
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Guilford Neurologic Associates
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research Inc.
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Kansas City Bone & Joint Clinic
state: Kansas
city: Overland Park
country: United States
facility: International Clinical Research Institute
state: Kansas
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Eagan
country: United States
facility: Rehabilitation Consultants PA
state: Minnesota
city: Stratford
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Summit
country: United States
facility: Atlantic Neuroscience Institute
state: New Jersey
city: Kingston
country: United States
facility: Kingston Neurological Associates
state: New York
city: New York
country: United States
facility: Fazzini Parkinson's Disease & Dystonia Center
state: New York
city: New York
country: United States
facility: The Ichan School of Medicine at Mount Sinai
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates
state: New York
city: Greensboro
country: United States
facility: Guilford Neurologic Associates; Cone Health Medical Group
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company, LLC
state: Ohio
city: Portland
country: United States
facility: OHSU Center for Health and Healing
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Neurology
state: Pennsylvania
city: Port Royal
country: United States
facility: Coastal Neurology
state: South Carolina
city: Bedford
country: United States
facility: North Texas Movement Disorders Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Tacoma
country: United States
facility: Puget Sound Neurology
state: Washington
Study officials:
affiliation: Ipsen
name: Medical Director, Neurology, M.D.
role: STUDY_DIRECTOR
References:
citation: Patel AT, Lew MF, Dashtipour K, Isaacson S, Hauser RA, Ondo W, Maisonobe P, Wietek S, Rubin B, Brashear A. Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study. PLoS One. 2021 Feb 1;16(2):e0245827. doi: 10.1371/journal.pone.0245827. eCollection 2021.