Blepharospasm is a focal dystonia characterised by excessive involuntary contraction of the orbicularis oculi muscles. In severe cases, tonic eyelid closure can lead to functional blindness and can have significant negative impact on the subject’s quality of life.
Conditions
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing to provide written informed consent. 2. Subjects of either sex, aged 18 years or above. 3. Women of childbearing potential who are willing to use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicidal, or surgical sterilisation) during the study. 4. Subjects diagnosed with benign essential blepharospasm. 5. Subjects with blepharospasm who have received =25U/eye (=50U total dose) of BOTOX® for at least one visit prior to study entry and who will, in the investigators opinion, require the same dose at the study injection visit. 6. Subjects who are able to understand the requirements of the study and in the opinion of the investigator will be able to comply with the requirements of the protocol. 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. Female subjects who are pregnant (positive urine pregnancy test), who are breastfeeding or who are of childbearing potential and not practicing a reliable method of birth control. 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 disease that might interfere with neuromuscular function. 4. Known significantly impaired renal and/or hepatic function. 5. Failure to meet prohibited/restricted concomitant medication criteria (section 5.3.10). 6. Subjects planning inpatient surgery or other elective hospitalisation during the study. 7. Any uncontrolled or unstable systemic disease. 8. Allergy or sensitivity to any component of the study medication (Section 5.4.1). 9. Subjects with a known recent history of substance (alcohol or drug) abuse. 10. History of poor cooperation, non-compliance with medical treatment. 11. Subject has a concurrent condition that may, in the opinion of the investigator, put him/her at significant risk, confound study results, or significantly interfere with the conduct of the study. 12. Subjects currently participating in another investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of BOTOX® versus Xeomin® (=25U/eye; =50U total dose) in the treatment of subjects with blepharospasm;Secondary Objective: To compare the safety of BOTOX® versus Xeomin® (=25U/eye; =50U total dose) in the treatment of subjects with blepharospasm;Primary end point(s): Change from baseline in severity of Jankovic Rating Scale (JRS) at Week 4 | — |
Countries
Germany
Outcome results
None listed