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

Primary Purpose

Essential Blepharospasm

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
Hugel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Blepharospasm focused on measuring Essential Blepharospasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hugel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botulinum Toxin Type A (Botulax)

Arm Description

Botulinum Toxin Type A (Botulax)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale
To evaluate the change of JRS (Jankovic Rating scale) score at 16 weeks post treatment based on baseline(0 week)
Change from baseline at 4 weeks and 16 weeks of Disability Index
To evaluate the change of Blepharospasm Disability Index at 4 weeks and 16 weeks post treatment. Functional disability assessment scale will be assessed as functional disability score. Functional disability assessment scale consists of 6 daily activities (reading, watching television, household activities (cleaning, etc.), mobility, driving, work).
Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection
To evaluate the Investigator's assessment of global response at Weeks 4 and 16 after treatment. At Weeks 4 and 16 Visits after treatment, the investigator will assess global response on a 9-point scale from -4 (marked worsening) to +4 (Complete abolition of all signs and symptoms).
Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)
To evaluate the change in WHO-Quality of Life (QoL) at Weeks 4 and 16 after treatment from baseline WHOQOL will be assessed by the brief Korean version of WHOQOL (WHOQOL-BREF). The Korean WHOQOL-BREF consists of a total of 26 subscales in 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Items in each subscale are in a range from 1 (not at all or very dissatisfied) to 5 (very much or very satisfied).

Full Information

First Posted
August 19, 2018
Last Updated
August 20, 2018
Sponsor
Hugel
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1. Study Identification

Unique Protocol Identification Number
NCT03641950
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 30, 2015 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
January 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Blepharospasm
Keywords
Essential Blepharospasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin Type A (Botulax)
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A (Botulax)
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Botulax
Intervention Description
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).
Primary Outcome Measure Information:
Title
Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale
Description
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.
Time Frame
At 4 weeks post-injection
Secondary Outcome Measure Information:
Title
Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale
Description
To evaluate the change of JRS (Jankovic Rating scale) score at 16 weeks post treatment based on baseline(0 week)
Time Frame
At 0 weeks and 16 weeks post-injection
Title
Change from baseline at 4 weeks and 16 weeks of Disability Index
Description
To evaluate the change of Blepharospasm Disability Index at 4 weeks and 16 weeks post treatment. Functional disability assessment scale will be assessed as functional disability score. Functional disability assessment scale consists of 6 daily activities (reading, watching television, household activities (cleaning, etc.), mobility, driving, work).
Time Frame
At 4 weeks and 16 weeks post-injection
Title
Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection
Description
To evaluate the Investigator's assessment of global response at Weeks 4 and 16 after treatment. At Weeks 4 and 16 Visits after treatment, the investigator will assess global response on a 9-point scale from -4 (marked worsening) to +4 (Complete abolition of all signs and symptoms).
Time Frame
At 4 weeks and 16 weeks post-injection
Title
Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL)
Description
To evaluate the change in WHO-Quality of Life (QoL) at Weeks 4 and 16 after treatment from baseline WHOQOL will be assessed by the brief Korean version of WHOQOL (WHOQOL-BREF). The Korean WHOQOL-BREF consists of a total of 26 subscales in 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Items in each subscale are in a range from 1 (not at all or very dissatisfied) to 5 (very much or very satisfied).
Time Frame
At 4 weeks and 16 weeks post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Hugel
City
Seoul
State/Province
Korea
ZIP/Postal Code
06162
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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