Clinical trial NCT03641950: The Objective of This Study is to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm.
Official title: Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Blepharospasm
Keywords: Essential Blepharospasm
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate the efficacy and safety of Botulax® in the treatment of Essential blepharospasm.

Detailed description: Multi-center, single arm, open-label, Phase IV clinical trial to evaluate the efficacy and safety of Botulax® in Subjects with essential blepharospasm

Eligibility criteria: Inclusion Criteria:

1. Men and women at the age of 18 or older
2. Subjects diagnosed with essential blepharospasm with Jankovic Rating Scale (JRS) frequency and severity sum score ≥2 at screening
3. Individuals who agree to participate in the clinical study and voluntarily sign the written informed consent form
4. Subjects who are cooperative, have a good understanding of the clinical study, and can comply with study procedures until the end of the study

Exclusion Criteria:

1. Subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication
2. Subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.)
3. Subjects with secondary blepharospasm
4. Subjects with the hemifacial spasm
5. Subjects on treatment with muscle relaxants, benzodiazepines, anticholinergics, or benzamides who had changes in medication within 4 weeks prior to screening or have been on stable medication but are expected to have changes in medication while participating in the study
6. Subjects who administered any of the following drugs within 7 days prior to screening: drugs with muscle relaxation activity such as aminoglycoside antibiotics or other antibiotics (spectinomycin HCl, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics)
7. Subjects who administered medications similar to the investigational product (botulinum toxin type A) within 12 weeks
8. Subjects with systemic neuromuscular junction disorders: myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis
9. Pregnant and lactating women
10. Women of childbearing potential who are planning to become pregnant within the next 3 months or are not using an appropriate method of contraception (contraceptive methods with an annual failure rate of less than 1% if used properly and continuously, including implant, injection, oral contraceptive, at least one barrier method such as intrauterine device \[IUD\], hormone IUD, abstinence, or vasectomized partner)

Primary outcomes:
measure: Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale
timeFrame: At 4 weeks post-injection
Secondary outcomes:
measure: Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale
timeFrame: At 0 weeks and 16 weeks post-injection
measure: Change from baseline at 4 weeks and 16 weeks of Disability Index
timeFrame: At 4 weeks and 16 weeks post-injection
measure: Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection
timeFrame: At 4 weeks and 16 weeks post-injection
measure: Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)
timeFrame: At 4 weeks and 16 weeks post-injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hugel
state: Korea
Study officials:
References: