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| Sponsor: | Allergan |
|---|---|
| Information provided by (Responsible Party): | Allergan |
| ClinicalTrials.gov Identifier: | NCT00528541 |
Purpose
The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck
| Condition | Intervention | Phase |
|---|---|---|
|
Spasmodic Torticollis |
Biological: botulinum toxin type A |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Enrollment: | 145 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: BOTOX®
botulinum toxin type A (BOTOX®)
|
Biological: botulinum toxin type A
200 Units at Visit 1 (Day 1)
Other Name: BOTOX®
|
|
Active Comparator: Dysport®
botulinum toxin type A (Dysport®)
|
Biological: botulinum toxin type A
750 Units at Visit 1 (Day 1)
Other Name: Dysport®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Australia, South Australia | |
| Adelaide, South Australia, Australia | |
| Croatia | |
| Zagreb, Croatia | |
| Italy | |
| Rome, Italy | |
| Poland | |
| Krakow, Poland | |
| Turkey | |
| Istanbul, Turkey | |
| Study Director: | Medical Director | Allergan |
More Information
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00528541 History of Changes |
| Other Study ID Numbers: | MedAff-BTX-0616 |
| Study First Received: | September 10, 2007 |
| Results First Received: | November 14, 2011 |
| Last Updated: | November 14, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Torticollis Dystonic Disorders Movement Disorders Central Nervous System Diseases Nervous System Diseases Dystonia Dyskinesias Neurologic Manifestations Signs and Symptoms |
Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |