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 efficacy and safety of two different doses of NT201 in botulinum toxin treatment-naïve subjects with blepharospasm

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2014/002

Enrollment

Registered

2014-01-14

Start date

2014-01-14

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Bilateral Blepharospasm (BEB)

Interventions

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),

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 ]	—

Measure

Time frame

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

Measure	Time frame
1. Change from baseline in Blepharospasm Disability Index [BSDI] at V4 (Week 6). The Blepharospasm Disability Index is a disease specific scale for subject functional self 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 BSDI will be assessed before rating the JRS for unbiased information by subject. 2. Patient Evaluation of Global Response [PEGR] at final visit of Main Period (V5). 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). [1. Baseline to week 6 2. Up to week 20 ]	—

Measure

Time frame

1. Change from baseline in Blepharospasm Disability Index [BSDI] at V4 (Week 6). The Blepharospasm Disability Index is a disease specific scale for subject functional self 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 BSDI will be assessed before rating the JRS for unbiased information by subject. 2. Patient Evaluation of Global Response [PEGR] at final visit of Main Period (V5). 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). [1. Baseline to week 6 2. Up to week 20 ]

—

Countries

Greece,India,Malaysia,Sri Lanka

Contacts

Public ContactDr. Bimsara Senanayake

Consultant Neurologist and Lead Principal Investigator,

bimsaras@sltnet.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026