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

NCT03641950 | Completed Phase 4 DMC

• 1 other identifier: HG-BOT-IV3
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Essential Blepharospasm

Keywords

Essential Blepharospasm

Outcome Measures

Primary Outcomes (1)

• Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale

  To evaluate the change of JRS (Jankovic Rating scale) score at 4 weeks post treatment based on baseline(0 week). JRS total score will be calculated as the sum (0\~8) of two sub-scores of severity and frequency (0\~4 each for severity and frequency) of blepharospasm.

  At 4 weeks post-injection

Secondary Outcomes (4)

• Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale

  At 0 weeks and 16 weeks post-injection

• Change from baseline at 4 weeks and 16 weeks of Disability Index

  At 4 weeks and 16 weeks post-injection

• Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection

  At 4 weeks and 16 weeks post-injection

• Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)

  At 4 weeks and 16 weeks post-injection

Study Arms (1)

Botulinum Toxin Type A (Botulax)

EXPERIMENTAL

Botulinum Toxin Type A (Botulax)

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A 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).

Also known as: Botulax

Botulinum Toxin Type A (Botulax)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who had received surgery such as orbicularis oculi resection or facial nerve block for the treatment of the study indication
• Subjects with a history of hypersensitivity reactions to any of the components of the investigational product (botulinum toxins, serum albumin, etc.)
• Subjects with secondary blepharospasm
• Subjects with the hemifacial spasm
• 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
• 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)
• Subjects who administered medications similar to the investigational product (botulinum toxin type A) within 12 weeks
• Subjects with systemic neuromuscular junction disorders: myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis
• Pregnant and lactating women
• 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)

Sponsors & Collaborators

• Hugel: lead

Study Sites (1)

Hugel

Seoul, Korea, 06162, South Korea

Location

MeSH Terms

Conditions

Benign essential blepharospasm

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: August 22, 2018
• Study Start: April 30, 2015
• Primary Completion: May 1, 2015
• Study Completion: January 7, 2016
• Last Updated: August 22, 2018

Record last verified: 2016-03

Locations

KR (1)