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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03641950
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Hugel

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

Condition or disease Intervention/treatment Phase
Essential Blepharospasm Drug: Botulinum toxin type A Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : January 7, 2016


Arm Intervention/treatment
Experimental: Botulinum Toxin Type A (Botulax)
Botulinum Toxin Type A (Botulax)
Drug: 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).
Other Name: Botulax




Primary Outcome Measures :
  1. Total score change from baseline at 4 weeks post-injection of Jankovic Rating scale [ Time Frame: At 4 weeks post-injection ]

    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 :
  1. Total score change from baseline at 16 weeks post-injection of Jankovic Rating scale [ Time Frame: At 0 weeks and 16 weeks post-injection ]
    To evaluate the change of JRS (Jankovic Rating scale) score at 16 weeks post treatment based on baseline(0 week)

  2. Change from baseline at 4 weeks and 16 weeks of Disability Index [ Time Frame: At 4 weeks and 16 weeks post-injection ]

    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).


  3. Global Response evaluated by investigator at 4 weeks and 16 weeks after post-injection [ Time Frame: At 4 weeks and 16 weeks 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).


  4. Change from baseline at 4 weeks and 16 weeks of WHO-Quality of Life(QOL) [ Time Frame: At 4 weeks and 16 weeks post-injection ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641950


Locations
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Korea, Republic of
Hugel
Seoul, Korea, Korea, Republic of, 06162
Sponsors and Collaborators
Hugel

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Responsible Party: Hugel
ClinicalTrials.gov Identifier: NCT03641950     History of Changes
Other Study ID Numbers: HG-BOT-IV3
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: March 2016

Keywords provided by Hugel:
Essential Blepharospasm

Additional relevant MeSH terms:
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Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents