Phase 3
N=109
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
Blepharospasm
Bottom Line
View on ClinicalTrials.gov: NCT00406367 ↗Enrolled (actual)
109
Serious AEs
0.9%
Results posted
Nov 2010
Primary outcome: Primary: Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) — -0.8; 0.2 Points on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- incobotulinumtoxinA (Xeomin) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz Pharmaceuticals GmbH
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) |
-0.8; 0.2 | <0.001 sig |
| SECONDARY Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) |
-0.75; 0.16 | — |
| SECONDARY Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection |
-0.4; 0.11 | — |
| SECONDARY Patient Evaluation of Global Response (PEGR) at Final Visit |
1.3; -0.6 | — |
Summary
Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.
Eligibility Criteria
Main Inclusion Criteria:
- Male or female pretreated outpatients between ages 18 and 80 years (inclusive)
- A clinical diagnosis of bilateral blepharospasm (BEB) characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
- A need for injection of Botulinum toxin (defined by a Jankovic Rating Scale (JRS) severity subscore >= 2)
- On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period
- Source documentation of the last two consecutive injection sessions with BOTOX® and a stable satisfactory therapeutic response directly prior to trial entry
- At least 10 weeks must have been passed between the last injection with BOTOX® for BEB and Baseline
Main Exclusion Criteria:
- Atypical variant of BEB caused by inhibition of levator palpebrae muscle
- Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation)
- The previous two injections with BOTOX® with more than 50 Units per eye
- Hypersensitivity to human serum albumin, sucrose, or Botulinum toxin A
- Neuroleptic induced blepharospasm
- Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
- Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to Baseline and during the trial
Data sourced from ClinicalTrials.gov (NCT00406367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.