Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004821-26-GR

Enrollment

Registered

2013-02-26

Start date

2013-04-01

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Blepharospasm (BEB) MedDRA version: 15.1 Level: PT Classification code 10005159 Term: Blepharospasm System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Xeomin Product Name: NT 201 Product Code: NT 201 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: n.a. CAS Number: 93384-43-1 Current Sponsor code: NT 101 Other

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Not applicable;Main Objective: This phase 3 study will serve to collect efficacy and safety data of two different doses of NT 201 in subjects suffering from 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. ;Primary end point(s): Change from baseline in JRS (Jankovic rating scale) severity subscore determined at V4 (Week 6) ;Timepoint(s) of evaluation of this end point: V4 at Day 43±3 days, i.e., Week 6 after the injection of IP (NT 201 or corresponding placebo)	—

Measure

Time frame

Secondary Objective: Not applicable;Main Objective: This phase 3 study will serve to collect efficacy and safety data of two different doses of NT 201 in subjects suffering from 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. ;Primary end point(s): Change from baseline in JRS (Jankovic rating scale) severity subscore determined at V4 (Week 6) ;Timepoint(s) of evaluation of this end point: V4 at Day 43±3 days, i.e., Week 6 after the injection of IP (NT 201 or corresponding placebo)

—

Secondary

Measure	Time frame
Secondary end point(s): - Change from baseline in Blepharospasm Disability Index (BSDI) score at Visit 4 (week 6) - Patient Evaluation of Global Response (PEGR) at final visit of Main Period (Visit 5) ;Timepoint(s) of evaluation of this end point: up to week 20	—

Countries

Greece, India, Malaysia, Sri Lanka

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026