Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid
This trial has been completed.
|Condition||bilateral blepharospasm (beb)|
|Treatments||incobulinumtoxina (xeomin), 25 units, incobotulinumtoxina (xeomin), 12.5 units, placebo, incobotulinumtoxina (xeomin), 35 units|
|Sponsor||Merz Pharmaceuticals GmbH|
|Start date||November 2013|
|End date||April 2016|
|Trial size||61 participants|
|Trial identifier||NCT01896895, 2012-004821-26, MRZ60201_3074_1|
This phase 3 study will serve to collect efficacy and safety data of two different doses of NT 201 in subjects suffering from Bilateral Blephorasm (BEB) who are BTX treatment-naïve.
In this study, BTX treatment-naïve subjects are defined as those who have not received BTX treatment within the last 12 months for the treatment of BEB. This definition aims to avoid bias by comparison of treatment effects in the subject's assessments. Furthermore, this study will substantiate the existing efficacy and safety database for the indication BEB.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Athens, Greece||Merz Investigational Site #030002||completed|
|Athens, Greece||Merz Investigational Site #030001||completed|
|Georgetown, Malaysia||Merz Investigational Site #060007||completed|
|Kota Kinabalu, Malaysia||Merz Investigational Site #060004||completed|
|Kuala Lumpur, Malaysia||Merz Investigational Site #060006||completed|
|Kuala Lumpur, Malaysia||Merz Investigational Site #060002||completed|
|Selangor, Malaysia||Merz Investigational Site #060003||completed|
|Colombo, Sri Lanka||Merz Investigational Site #094001||completed|
|Colombo, Sri Lanka||Merz Investigational Site #094005||completed|
|Kurunegala, Sri Lanka||Merz Investigational Site #094006||completed|
|Nugegoda, Sri Lanka||Merz Investigational Site #094002||completed|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change from baseline in Jankovic rating scale (JRS) severity subscore determined at V4 (Week 6)
time frame: Baseline to week 6
Change from baseline in Blepharospasm Disability Index (BSDI) score at Visit 4 (week 6)
time frame: Baseline to week 6
Patient Evaluation of Global Response [PEGR] at final visit of Main Period (V5 -up to week 20)
time frame: Up to week 20
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Male or female out-patients age ≥ 18 and ≤ 80 years. - A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of orbicular oculi muscles. - A need for injection of BTX defined as a Jankovic Rating Scale [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: - 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 levator palpebrae 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.
|Official title||Prospective, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of Two Different Doses of NT 201 in Botulinum Toxin Treatment-naïve Subjects With Blepharospasm|
|Description||Subjects to receive one injection with NT 201 or placebo at baseline of the placebo-controlled first cycle. Thereafter, all subjects entering the Open-Label Extension Period (OLEX) to receive a second injection of NT 201 (second injection cycle).|
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