The Objective of This Study is to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm.

NCT ID: NCT03641950

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-01-07

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

Conditions

Essential Blepharospasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botulinum Toxin Type A (Botulax)

Botulinum Toxin Type A (Botulax)

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

Recommended initial dose to be intra-muscularly injected to the medial and contralateral pretarsal orbicularis oculi of the upper eyelid and the contralateral pretarsal orbicularis oculi of the lower eyelid is 1.25-2.5U (0.05ml \~ 0.1ml per site).

Interventions

Botulinum toxin type A

Recommended initial dose to be intra-muscularly injected to the medial and contralateral pretarsal orbicularis oculi of the upper eyelid and the contralateral pretarsal orbicularis oculi of the lower eyelid is 1.25-2.5U (0.05ml \~ 0.1ml per site).

Intervention Type: DRUG

Other Intervention Names

Botulax

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hugel

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hugel

Seoul, Korea, South Korea

Countries

South Korea

Other Identifiers

HG-BOT-IV3

Identifier Type: -

Identifier Source: org_study_id