Clinical trial NCT01753336: Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
Official title: A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport® Using 2 mL 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: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).


Eligibility criteria: Inclusion Criteria:

* Subjects enrolled in Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy
* Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport® for CD

Exclusion Criteria:

* Diagnosis of pure retrocollis or pure anterocollis
* Requirement for Botulinum Neurotoxin (BoNT) injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study
* Known hypersensitivity to BoNT or related compounds, or any component in the study drug formulation
* Allergy to cow's milk protein
* Myasthenia gravis, other disease of the neuromuscular junction or clinically significant, persistent neuromuscular weakness, or disease or symptoms that could interfere with the TWSTRS scoring
* Total body weight \<95 lbs (43.09 kg)
* Previous phenol injections to the neck muscles
* Previous myotomy or denervation surgery involving the neck or shoulder region or deep brain stimulation to treat CD
* Cervical contracture that limited passive range of motion
* Physiotherapy initiated \<4 weeks before study entry or expected to be initiated during the study
* Treatment with aminoglycoside antibiotics within 30 days prior to study treatment
* Current or expected requirement for concomitant medication that could interfere with the evaluation of study treatment
* Pregnant and/or lactating females
* Females of childbearing potential with a positive prestudy urine pregnancy test (a positive urine pregnancy test could be confirmed by a serum pregnancy test at the discretion of the investigator) and subjects, or their partners, who did not agree to use adequate contraception (hormonal or barrier method of birth control) prior to injection of study treatment and for the duration of study participation. Nonchildbearing potential is defined as postmenopause for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy
* Individuals who had family or employee relationship to study site staff or sponsor staff involved in the conduct of the study
* Any medical condition that could, as judged by the investigator, compromise compliance with the objectives and procedures of this protocol or preclude the administration of BoNT, including swallowing and other respiratory abnormality.
* Subjects who were unable and/or unwilling to comply fully with the protocol and the study instructions, as judged by the investigator

Primary outcomes:
measure: TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
timeFrame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Secondary outcomes:
measure: TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
timeFrame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
measure: Treatment Response in Treatment Cycle 3 Week 4.
timeFrame: Week 4 Treatment Cycle 3
measure: TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
timeFrame: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
measure: TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
timeFrame: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
measure: TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
timeFrame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
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: Sutter Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologist of Southern CT, PC
state: Connecticut
city: New Haven
country: United States
facility: Yale Medical Group, Yale University
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and 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: Parkinson's Treatment Center of SW Florida
state: Florida
city: Tampa
country: United States
facility: USF HealthParkinson's Disease and Movement Disorders Center
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: 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, PA
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: Dashtipour K, Wietek S, Rubin B, Maisonobe P, Bahroo L, Trosch R. AbobotulinumtoxinA using 2-mL dilution (500 U/2-mL) maintains durable improvement across multiple treatment cycles. J Clin Mov Disord. 2020 Aug 31;7:8. doi: 10.1186/s40734-020-00090-x. eCollection 2020.