Status:
COMPLETED
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Bilateral Blepharospasm (BEB)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This phase 3 study will serve to collect efficacy and safety data of two different doses of NT 201 in subjects suffering from Bilateral Blepharospasm (BEB) who are BTX treatment-naïve. In this study,...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01896895
Start Date
November 1 2013
End Date
November 1 2016
Last Update
March 1 2018
Active Locations (11)
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1
Merz Investigational Site #030002
Athens, Greece, 11521
2
Merz Investigational Site #030001
Athens, Greece, 11526
3
Merz Investigational Site #060007
George Town, Pulau Pinang, Malaysia, 10990
4
Merz Investigational Site #060004
Kota Kinabalu, Sabah, Malaysia, 88586