Cervical dystonia: cervical dystonia that have never received treatment with botulinum toxin of any serotype for cervical dystonia or for any other indication
Conditions
Sponsors
Allergan, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 18 - 75 years of age with clinically diagnosed idiopathic cervical dystonia or segmental or generalized dystonia in which cervical dystonia is the predominant feature 2. Knowledge and ability (were it not for the cervical dystonia) to participate in all activities except driving mentioned in the TWSTRS Disability subscale. 3. A total score of > 20 on the total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) 4. A TWSTRS torticollis severity score of = 10 5. A TWSTRS pain subscale score of >1 6. One of the following: (a) no treatment for cervical dystonia (CD) within 6 weeks prior to Day 1 OR (b) existing treatment for CD is stable (ie, no changes within 6 weeks) prior to Day 1 (randomization) and is anticipated to remain stable throughout the study. This includes any pharmacological or non-pharmacological treatment 7. Negative urine pregnancy test on Day 1 immediately prior to injection for female patients of child-bearing potential 8. Screening laboratory values (hematology and chemistry) either within the reference ranges as defined by the central laboratory or in the investigator’s opinion out–of range test results that are acceptable to the investigator with the agreement from the medical monitor 9. Written informed consent has been obtained 10. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained 11. Written Data Protection Consent (European 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 be readily contactable by telephone for the duration of the study 14. Ability to follow study instructions and likely to complete all study requirements 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
Exclusion criteria: 1. Uncontrolled medical condition other than the condition under evaluation 2. Concurrent or previous botulinum toxin treatment of any serotype for any condition, or immunization to any botulinum toxin serotype 3. Any medical condition that may place the patient at increased risk with exposure to BOTOX® or BOTOX® rHA-R including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other condition that might interfere with neuromuscular function 4. Known allergy or sensitivity to the study medication(s) or its components 5. Previous surgical procedure involving bone or muscle for the management of cervical dystonia 6. Previous injections of phenol or alcohol that, in the investigator’s opinion, have altered muscle anatomy 7. Profound atrophy of the muscles to be injected 8. Presence of pure latero and/or antero/retrocollis, or pure shift. Neck contracture producing decreased range of motion 9. Anticipated need during the study for any surgical procedure for the management of cervical dystonia that might result in a modification of the patient’s dose of study drug 10. Infection or skin problem at the anticipated injection sites 11. Patient is female and pregnant, nursing or planning a pregnancy during the study or is of child-bearing potential and unable or unwilling to use a reliable form of contraception during the study 12. Anticipated need for botulinum toxin treatment of any serotype for any indication (other than the study treatment for cervical dystonia) during the study 13. Recent history in the past two years of alcohol or drug abuse 14. Anticipated need for surgery or hospitalization during the study 15. Concurrent participation in another investigational drug or device study or participation in such a study within 30 days of entry into this study 16. Patient has a condition or is in a situation which in the investigator’s opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the use of the TWSTRS scale in a cervical dystonia population treated with two formulations of BOTOX® or placebo ;Secondary Objective: ;Primary end point(s): Difference in the mean change from baseline in the total TWSTRS score, which has a minimum score of 0 and a maximum score of 85 on a composite rating scale with subscales for torticollis severity (score range of 0-35), disability (score range of 0-30) and pain (score range of 0-20). | — |
Countries
Czech Republic, Germany, Hungary, Portugal, United Kingdom
Outcome results
None listed