Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

Cervical Dystonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753336
• Other study ID #: A-TL-52120-170
• Status: Completed
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: October 2015

Study information

• Verified date: July 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Biological:
• Botulinum toxin type A
Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	NeuroTrials Research Inc.	Atlanta	Georgia
United States	North Texas Movement Disorders Institute	Bedford	Texas
United States	East Bay Physician's Group	Berkeley	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Tufts Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati Physicians Company, LLC	Cincinnati	Ohio
United States	Rehabilitation Consultants, PA	Eagan	Minnesota
United States	Associated Neurologist of Southern CT, PC	Fairfield	Connecticut
United States	Advanced Neurosciences Research	Fort Collins	Colorado
United States	Parkinson's and Movement Disorder Institute	Fountain Valley	California
United States	University of Florida Center for Movement Disorders and Neurorestoration	Gainesville	Florida
United States	Guilford Neurologic Associates; Cone Health Medical Group	Greensboro	North Carolina
United States	Penn State Hershey Neurology	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Kansas City Bone & Joint Clinic	Kansas City	Kansas
United States	Kingston Neurological Associates	Kingston	New York
United States	Loma Linda University Healthcare, Department of Neurology	Loma Linda	California
United States	USC Keck School of Medicine	Los Angeles	California
United States	Yale Medical Group, Yale University	New Haven	Connecticut
United States	The Ichan School of Medicine at Mount Sinai	New York	New York
United States	International Clinical Research Institute	Overland Park	Kansas
United States	Emerald Coast Center for Neurological Disorders	Pensacola	Florida
United States	Island Neurological Associates	Plainview	New York
United States	Parkinson's Treatment Center of SW Florida	Port Charlotte	Florida
United States	Coastal Neurology, PA	Port Royal	South Carolina
United States	OHSU Center for Health and Healing	Portland	Oregon
United States	Sutter Cancer Center	Sacramento	California
United States	UC Davis Medical Center	Sacramento	California
United States	Movement Disorders Center of Arizona, LLC	Scottsdale	Arizona
United States	University of Medicine and Dentistry of New Jersey	Stratford	New Jersey
United States	Atlantic Neuroscience Institute	Summit	New Jersey
United States	Puget Sound Neurology	Tacoma	Washington
United States	USF HealthParkinson's Disease and Movement Disorders Center	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	Guilford Neurologic Associates	West Palm Beach	Florida
United States	Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.	Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.	Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Secondary	TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.	The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle.	Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Secondary	Treatment Response in Treatment Cycle 3 Week 4.	Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented.	Week 4 Treatment Cycle 3
Secondary	TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.	Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.	Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
Secondary	TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.	Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.	Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)
Secondary	TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.	Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.	Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)

External Links

•   A-TL-52120-169