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IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
This study has been completed.
Sponsor:
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00406367
First received: November 30, 2006
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Blepharospasm | Drug: incobotulinumtoxinA (Xeomin) Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of incobotulinumtoxinA (Xeomin) in the Treatment of Blepharospasm |
Resource links provided by NLM:
Further study details as provided by Merz Pharmaceuticals GmbH:
Primary Outcome Measures:
- Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) [ Time Frame: Baseline, week 6 ]
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:
- JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)
- JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Secondary Outcome Measures:
- Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) [ Time Frame: Baseline, week 6 ]
The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:
- JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)
- JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
- Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection [ Time Frame: Baseline, week 6 ]The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
- Patient Evaluation of Global Response (PEGR) at Final Visit [ Time Frame: Final visit (up to week 20 after injection of the Main Period) ]The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).
| Enrollment: | 109 |
| Study Start Date: | October 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: incobotulinumtoxinA (Xeomin)
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to 50 Units per eye; Open-Label Extension Period: up to 5 injections, up to 50 Units per eye per injection session; Mode of administration: intramuscular injection
|
Drug: incobotulinumtoxinA (Xeomin)
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection
|
|
Placebo Comparator: Placebo
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
|
Drug: Placebo
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406367
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406367
Locations
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Canada, Nova Scotia | |
| David King, MD - Private Practice | |
| Halifax, Nova Scotia, Canada, B3J 3T1 | |
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
| Study Chair: | Joseph Jankovic, Prof. | Houston, Texas |
More Information
Publications:
| Responsible Party: | Merz Pharmaceuticals GmbH |
| ClinicalTrials.gov Identifier: | NCT00406367 History of Changes |
| Other Study ID Numbers: |
MRZ 60201-0433 |
| Study First Received: | November 30, 2006 |
| Results First Received: | August 31, 2010 |
| Last Updated: | March 13, 2013 |
Additional relevant MeSH terms:
|
Blepharospasm Eyelid Diseases Eye Diseases Pharmaceutical Solutions Botulinum Toxins, Type A incobotulinumtoxinA Neuromuscular Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on September 21, 2017