Home » Trials » SLCTR/2014/002
Prospective, double-blind, placebo-controlled, randomized, parallel-group, multi-center study with an open-label extension period to investigate efficacy and safety of two different doses of NT201 in botulinum toxin treatment-naïve subjects with blepharospasm
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SLCTR Registration Number
SLCTR/2014/002
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Prospective, double-blind, placebo-controlled, randomized, parallel-group, multi-center study with an open-label extension period to investigate efficacy and safety of two different doses of NT201 in botulinum toxin treatment-naïve subjects with blepharospasm
Public Title of Trial
Efficacy and safety study of botulinum toxin type A against placebo to treat abnormal contraction or twitch of the eyelid
Disease or Health Condition(s) Studied
Bilateral Blepharospasm (BEB)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
MRZ60201_3074_1, EudraCT Number – 2012-004821-26, NCT-01896895, IND Number- 100163
What is the research question being addressed?
What is the efficacy and safety of two different doses of NT 201 (a botulinum neurotoxin type A free from complexing proteins) compared to a placebo in the treatment of patients with bilateral Bleparospasm (BEB) who have not been previously treated with Botulinum toxin? .
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Main Period (MP): One injection session. Three arms: i. IncobotulinumtoxinA (NT201, Xeomin) – 12.5 U per eye; ii. IncobotulinumtoxinA (NT201, Xeomin) – 25 U per eye; iii. Placebo (comparator).
Open Label Extension Period (OLEX): One injection session, IncobotulinumtoxinA (NT 201, Xeomin) – up to 35 U per eye.
Intervention: IncobotulinumtoxinA (NT201, Xeomin), active ingredient: Clostridium Botulinum neurotoxin type A (150 kiloDalton) free from complexing proteins. Powder for solution for injection, prepared by reconstitution with 0.9% Sodium Chloride (NaCl).
Placebo to IncobotulinumtoxinA (NT 201, Xeomin), powder for solution for injection, prepared by reconstitution with 0.9% Sodium Chloride (NaCl).
Mode of administration: intramuscular injection. Duration: The duration of study participation for the individual subject is up to 41 weeks.
Inclusion criteria
Main Inclusion Criteria: • Male or female outpatients > 18 and < 80 years • Clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of orbicular oculi muscles. • Need for injection of BTX defined as a JRS severity subscore 2. • Treatment-naïve subject defined as at least 12 months without BTX of any serotype for the treatment of BEB before administration of IP.
Exclusion criteria
Main Exclusion Criteria: • Subject with any previous unsuccessful treatment with BTX of any serotype for the treatment of BEB. • Atypical variant of BEB (e.g., apraxia of the eyelid opening) caused by inhibition of levatorpalpebrae muscle. • Neuroleptic-induced blepharospasm. • Myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation, spinal cord stimulation) and surgery in the upper face. • Generalized disorders of muscles activity (e.g., myasthenia gravis in particular ocularis, Lambert-Eaton-Syndrome,amyotrophic lateral sclerosis) or any other significant neuromuscular dysfunction which might interfere with the study.
Primary outcome(s)
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1.
Change from baseline in Jankovic Rating Scale [JRS] severity sub-score at visit 4 (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-Severity sub-score is used, which ranges from 0 (=absence of severity) to 4 (=maximum severity). |
[ Baseline to week 6 ] |
Secondary outcome(s)
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1.
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Target number/sample size
60
Countries of recruitment
Greece, India, Malaysia, Sri Lanka
Anticipated start date
2014-01-14
Anticipated end date
2016-03-31
Date of first enrollment
2013-02-12
Date of study completion
Recruitment status
Pending
Funding source
Merz Pharmaceuticals GmbH, Germany
Regulatory approvals
Status
Approved
Date of Approval
2013-04-10
Approval number
Not available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Bimsara Senanayake
Consultant Neurologist and Lead Principal Investigator,
Colombo South Teaching Hospital
Kalubowila
Sri Lanka
94 773046096
94-721846595.
bimsaras@sltnet.lk
Contact Person for Public Queries
Dr. Bimsara Senanayake
Consultant Neurologist and Lead Principal Investigator,
Colombo South Teaching Hospital
Kalubowila
Sri Lanka
94 773046096
94-721846595.
bimsaras@sltnet.lk
Primary study sponsor/organization
Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
60318 Frankfurt am Main, Germany
+49 69 1503 0
+49 69 1503 200
Clinicaltrials@merz.de
www.merz.de
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
