Multicenter, Double-Blind, Randomized, Controlled, Parallel Comparison of Efficacy and Safety of Fixed Doses of Two Formulations of Botulinum Toxin Type A in the Treatment of Moderate to Severe Cervical Dystonia (BOTOX® 200 Units and Dysport® 750 Units)

• Conditions: Moderate to Severe Cervical Dystonia

• Registration Number: EUCTR2006-006449-14-DE
• Lead Sponsor: Allergan Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-14
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Subjects with idiopathic cervical dystonia of the predominantly rotational form (i.e., spasmodic torticollis) of minimum duration eighteen (18) months.
2. Moderate-to-severe symptoms as defined by a minimum Toronto Western Spasmodic Torticollis Scale (TWSTRS) severity scale score of 15, with a rotation score >2 and a duration factor >2.
3. Subjects have received successful treatment as determined clinically by both the investigator and patient with 180 – 220 U BOTOX® in each of the last two (2) treatment sessions.
4. Cervical dystonia symptom severity is considered predictable and successfully responsive to BOTOX® treatment.
5. The most recent treatment with BOTOX® occurred on a date at least 16 weeks prior to study entry, and the subject has received two (2) treatment sessions within the prior 40 weeks with a good clinical response.
6. Outpatient, male or female subjects, of any race, age 18 and older.
7. Screening laboratory values either within the reference ranges as defined by the laboratory or in the investigator’s opinion out of range test results that are not clinically significant.
8. Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for female subjects of childbearing potential).
9. Written informed consent has been obtained.
10. Written Authorization for Use and Release of Health and Research Study Information (as applicable) has been obtained.
11. Written Data Protection Consent (European and Indian sites only) has been obtained.
12. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
13. Ability to follow study instructions and likely to complete all required visits.

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

Exclusion Criteria

1. Symptomatic or non-idiopathic cervical dystonia.
2. Current or previous surgery, peripheral denervation, and/or spinal cord stimulation for the management of cervical dystonia.
3. Previous injections of phenol or alcohol for cervical dystonia.
4. History or evidence of secondary non-response to botulinum toxin type A therapy.
5. Presence of significant anterocollis, retrocollis, or head shift as the principal component of cervical dystonia.
6. Profound atrophy of the muscles in the target area(s) of injection.
7. Infection or skin problem at the anticipated injection site.
8. Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
9. Current anticoagulant therapy.
10. Failure to meet prohibited/restricted concomitant medication criteria:
11. Subjects planning inpatient surgery or other elective hospitalization during the study period.
12. Females who are pregnant, nursing, or planning a pregnancy (positive urine pregnancy test).
13. Females of childbearing potential, not using a reliable means of contraception.
14. Any uncontrolled systemic disease.
15. History of treatment with botulinum toxin type A of any brand other than BOTOX® within the past two (2) years.
16. History of treatment with botulinum toxin type B within the past two (2) years.
17. Allergy or sensitivity to any component of the study medication.
18. Recent history of alcohol or drug abuse (as defined by DSM IV criteria).
19. History of poor cooperation, non-compliance with medical treatment, or unreliability.
20. Subjects currently participating in another investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.
21. Any condition or situation which, in the investigator’s opinion, places the patient at significant risk, could confound the study results, or may interfere significantly with the patient’s participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified