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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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