A Double-Blind, Randomised, Cross-over, Safety and Efficacy Pilot Study Comparing Two Botulinum Toxin Type-A Products in the Treatment of Moderate to Severe Cervical Dystonia. - BOTOX® vs. Xeomin® bei zervikaler Dystonie
- Conditions
- Cervical dystonia is the most common form of focal dystonia prevalent at a rate of 89 per million individuals. Sustained involuntary contractions of the neck muscles, lead to painful and disabling neck spasms with abnormal postures of the head.
- Registration Number
- EUCTR2005-006169-15-DE
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
1.Willing to provide written informed consent.
2.Subjects of either sex, aged between 18 and 70 years.
3.Toronto Western Spasmodic Torticollis Scale (TWSTRS) severity score of >15.
4.Cervical dystonia of the predominantly rotational form (i.e., rotation score > 2 and higher than the score for laterocollis or retrocollis)
5.Subjects who have been on a stable dose of BOTOX® for at least 2 visits prior to study entry.
6.Subjects who in the opinion of the Investigator will be able to comply with the requirements of the protocol
7.If female and of childbearing potential, the subject must use adequate birth control measures (eg; abstinence, oral contra¬ceptives, intrauterine device, barrier method with spermicide, or surgical sterilisation) during the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Presence of pure anterocollis or pure head shift as the sole component of cervical dystonia.
2.Profound atrophy of the muscles in the target area(s) of injection.
3.Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other neurological disease that might interfere with neuromuscular function.
4.Significant underlying dysphagia.
5.Current anticoagulant therapy and an International Normalised Ratio (INR) above the normal range.
6.Significantly impaired renal and/or hepatic function.
7.Failure to meet prohibited/restricted concomitant medication criteria.
8.Subjects planning inpatient surgery or other elective hospitali¬sation during the study.
9.Any uncontrolled systemic disease.
10.Subjects with a known recent history of substance (drug and alcohol) abuse.
11.Allergy or sensitivity to any component of the study medication.
12.TWSTRS Total score of less than 30.
13.Subjects currently participating in another investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.
14.Pregnant, breast-feeding or lactating women.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective<br>To compare the efficacy of intramuscular BOTOX® versus Xeomin® in the treatment of moderate to severe cervical dystonia.<br>;Secondary Objective: Secondary Objective<br>To compare the safety of intramuscular BOTOX® versus Xeomin® in the treatment of moderate to severe cervical dystonia.<br>;Primary end point(s): Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores 4 weeks after treatment
- Secondary Outcome Measures
Name Time Method