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
Verified date | September 2022 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
United States, Russian Federation,
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
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 |
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