Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00257660
First received: November 22, 2005
Last updated: June 17, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Dystonia |
Drug: Botulinum type A toxin (Dysport®) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]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.
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]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.
- Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
- Investigator VAS for CD Symptom Assessment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
- Subject VAS for CD Symptom Assessment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).
- Investigator's VAS for CD Symptom Assessment [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
- Subject VAS for CD Symptom Assessment [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).
- Investigator's VAS for CD Symptom Assessment [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
- SF-36 Mental Health Summary Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]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).
- SF-36 Physical Health Summary Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]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).
- Number of Participants Considered by the Investigator to be Overall Treatment Successes [ Time Frame: Week 12 ] [ Designated as safety issue: No ]The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
| Enrollment: | 116 |
| Study Start Date: | October 2005 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Drug: abobotulinumtoxinA (Dysport®)
|
Drug: Botulinum type A toxin (Dysport®)
500 units
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
500 units
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257660
Locations
| United States, Arizona | |
| St. Joseph's Hospital and Medical Center | |
| Phoenix, Arizona, United States | |
| United States, California | |
| Parkinson's and Movement Disorder Institute | |
| Fountain Valley, California, United States | |
| USC School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States | |
| University of Miami | |
| Miami, Florida, United States | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States | |
| United States, Maryland | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States | |
| United States, Michigan | |
| Wayne State University Medical Center | |
| Southfield, Michigan, United States | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States | |
| Columbia University | |
| New York, New York, United States | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Wake Forest University | |
| Winston Salem, North Carolina, United States | |
| United States, Pennsylvania | |
| Allegeheny General | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Texas | |
| University of Texas Southwest | |
| Dallas, Texas, United States | |
| Baylor College of Medicine | |
| Houston, Texas, United States | |
| United States, Washington | |
| Swedish Neuroscience | |
| Seattle, Washington, United States | |
| Russian Federation | |
| Scientific Research Institute of Neurology, RAMS | |
| Moscow, Russian Federation, 123367 | |
| Clinic "Cecil Plus" | |
| Moscow, Russian Federation, 125047 | |
| St Petersburg Pavlov State Medical University | |
| St Petersburg, Russian Federation, 197022 | |
| Municipal Multi-Speciality Hospital #2 | |
| St Petersburg, Russian Federation, 194354 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Jean-Loic Robin | Ipsen |
More Information
Publications:
| Responsible Party: | Jean-Loic Robin, Ipsen |
| ClinicalTrials.gov Identifier: | NCT00257660 History of Changes |
| Other Study ID Numbers: | Y-47-52120-051 |
| Study First Received: | November 22, 2005 |
| Results First Received: | January 6, 2010 |
| Last Updated: | June 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Torticollis Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Movement Disorders Central Nervous System Diseases Botulinum Toxins, Type A Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013