Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00257660 |
|
Recruitment Status :
Completed
First Posted : November 23, 2005
Results First Posted : May 10, 2010
Last Update Posted : July 13, 2020
|
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Dystonia | Biological: Botulinum toxin type A Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 116 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Actual Study Start Date : | October 10, 2005 |
| Actual Primary Completion Date : | September 2006 |
| Actual Study Completion Date : | September 2006 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 1
Drug: abobotulinumtoxinA (Dysport®)
|
Biological: Botulinum toxin type A
500 units
Other Name: AbobotulinumtoxinA (Dysport®) |
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
500 units |
Primary Outcome Measures :
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline and Week 4 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257660
Locations
Show 22 study locations
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00257660 |
| Other Study ID Numbers: |
Y-47-52120-051 2005-000709-70 ( EudraCT Number ) |
| First Posted: | November 23, 2005 Key Record Dates |
| Results First Posted: | May 10, 2010 |
| Last Update Posted: | July 13, 2020 |
| Last Verified: | June 2020 |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Torticollis Dyskinesias Neurologic Manifestations Nervous System Diseases Movement Disorders Central Nervous System Diseases Botulinum Toxins Botulinum Toxins, Type A |
abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |