Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

Cervical Dystonia Clinical Trial

Official title:

A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257660
• Other study ID #: Y-47-52120-051
• Secondary ID: 2005-000709-70
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2005
• Est. completion date: September 2006

Study information

• Verified date: September 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
• TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion Criteria:

• Pure anterocollis or pure retrocollis
• In apparent remission from cervical dystonia
• Previous poor response to the last two botulinum toxin type A or type B treatments
• Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Biological:
• Botulinum toxin type A
500 units

Drug:
• Placebo
500 units

Locations

Country	Name	City	State
Russian Federation	Clinic "Cecil Plus"	Moscow
Russian Federation	Scientific Research Institute of Neurology, RAMS	Moscow
Russian Federation	Municipal Multi-Speciality Hospital #2	St Petersburg
Russian Federation	St Petersburg Pavlov State Medical University	St Petersburg
United States	Albany Medical Center	Albany	New York
United States	Emory University	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Texas Southwest	Dallas	Texas
United States	Parkinson's and Movement Disorder Institute	Fountain Valley	California
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	USC School of Medicine	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Beth Israel Medical Center	New York	New York
United States	Columbia University	New York	New York
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Allegeheny General	Pittsburgh	Pennsylvania
United States	Swedish Neuroscience	Seattle	Washington
United States	Wayne State University Medical Center	Southfield	Michigan
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Russian Federation, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)	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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.	Baseline and Week 4
Secondary	Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)	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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.	Baseline and Week 8
Secondary	Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score	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. The change in TWSTRS total score is the score at week 4 minus the score at baseline.	Baseline and Week 12
Secondary	Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment	The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).	Baseline and Week 4
Secondary	Investigator VAS for CD Symptom Assessment	The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).	Baseline and Week 4
Secondary	Subject VAS for CD Symptom Assessment	The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).	Baseline and Week 8
Secondary	Investigator's VAS for CD Symptom Assessment	The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).	Baseline and week 8
Secondary	Subject VAS for CD Symptom Assessment	The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).	Baseline and week 12
Secondary	Investigator's VAS for CD Symptom Assessment	The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).	Baseline and week 12
Secondary	SF-36 Mental Health Summary Score	SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).	Week 8
Secondary	SF-36 Physical Health Summary Score	SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).	Week 8
Secondary	Number of Participants Considered by the Investigator to be Overall Treatment Successes	The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.	Week 12