Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

A Phase III, Prospective, Multicenter, Open-label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Cervical Dystonia

The aim of this study is to assess longer term safety and effectiveness of Dysport®.

Study Overview

• Status: Completed
• Conditions: Cervical Dystonia
• Intervention / Treatment: Biological: Botulinum toxin type A

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 123367
    • Scientific Research Institute of Neurology, RAMS
  • Moscow, Russian Federation, 125047
    • Clinic "Cecil Plus"
  • St Petersburg, Russian Federation, 194354
    • Municipal Multi-Speciality Hospital #2
  • St Petersburg, Russian Federation, 197022
    • St Petersburg Pavlov State Medical University
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
  • California
    • Fountain Valley, California, United States, 92708
      • The Parkinson's and Movement Disorder Institute
    • Los Angeles, California, United States, 90033
      • Usc School Of Medicine
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida, Dept of Neurology
    • Miami, Florida, United States, 33136
      • University of Miami, Dept of Neurology
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University School of Medicine, Wesley Woods Health Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa, Dept of Neurology
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Wayne State University Medical Center
  • New York
    • Albany, New York, United States, 12205
      • Albany Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center, Neurological Institute
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Texas
    • Dallas, Texas, United States, 75309
      • University of Texas Southwest Medical Center, Movement Disorder Clinic
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
• Returned to pre-treatment status as judged by the Investigator

Exclusion Criteria:

• Pure anterocollis or pure retrocollis
• Known antibodies to botulinum toxin type A
• Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
• Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dysport; 250-1000 units

Biological: Botulinum toxin type A; In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety & efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.; Other Names: AbobotulinumtoxinA (Dysport®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline	TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.	Week 4 follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline	TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.	Week 4 follow-up visit
Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline	TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.	Week 4 follow-up visit
Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline	TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.	Week 4 follow-up visit

Collaborators and Investigators

• Sponsor: Ipsen

Publications and helpful links

General Publications

• Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. doi: 10.1016/j.parkreldis.2010.03.002. Epub 2010 Mar 31.
• Mordin M, Masaquel C, Abbott C, Copley-Merriman C. Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study. BMJ Open. 2014 Oct 16;4(10):e005150. doi: 10.1136/bmjopen-2014-005150.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: February 7, 2006
• First Submitted That Met QC Criteria: February 7, 2006
• First Posted (Estimate): February 8, 2006

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Torticollis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: Y-47-52120-731; 2005-002429-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).