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Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm

Primary Purpose

Essential Blepharospasm

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hugeltox
Botulinum Toxin Type A(Botox®)
Sponsored by
Hugel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Blepharospasm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult between ages 18 and 75 years
  • All patients, diagnosed of essential blepharospasm, with Grade 2~4 of Severity of Spmasm (by Scott's Method)

Exclusion Criteria:

  • Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy
  • Patients with hypersensitivity history to botulinum toxin products previously
  • Patients with secondary blepharomspasm
  • Patients with hemifacialspasm
  • Patients with treatment following drugs ; Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa
  • Patients with previous injection of other botulinum toxin products in 3 months
  • Patients with any other significant neuromuscular disease like Myasthenia gravis
  • Pregnant or breastfeeding women

Sites / Locations

  • Cha Hospital
  • Seoul National University Hospital - Bundang
  • Youngnam University Hospital
  • Chungang University Hospital
  • Kim's eye hospital
  • Samsung medical Center
  • The Catholic University, Seoul, St.Mary's hospital
  • The catholic university, Yeouido, St. Mary's hospital
  • Yeonsei University, Severance hospital - Gangnam

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Botulinum toxin type A(Botox®)

Botulinum toxin type A(Hugeltox)

Arm Description

Botulinum toxin type A(Botox®)

Botulinum toxin type A(Hugeltox)

Outcomes

Primary Outcome Measures

Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)

Secondary Outcome Measures

(1) Duration of action days
(2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status
(3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)
(4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method)

Full Information

First Posted
February 13, 2013
Last Updated
February 13, 2013
Sponsor
Hugel
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1. Study Identification

Unique Protocol Identification Number
NCT01791881
Brief Title
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
Official Title
Double-blinded, Randomized, Active Control Comparative, Parallel-designed, Phase III Clinical Trial: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." In Essential Blepharospasm Running Parallel With Phase I Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin type A(Botox®)
Arm Type
Active Comparator
Arm Description
Botulinum toxin type A(Botox®)
Arm Title
Botulinum toxin type A(Hugeltox)
Arm Type
Experimental
Arm Description
Botulinum toxin type A(Hugeltox)
Intervention Type
Drug
Intervention Name(s)
Hugeltox
Intervention Description
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A(Botox®)
Intervention Description
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Primary Outcome Measure Information:
Title
Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method)
Time Frame
at 4 weeks post-injection
Secondary Outcome Measure Information:
Title
(1) Duration of action days
Time Frame
6 months
Title
(2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status
Time Frame
at four weeks post-injection
Title
(3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)
Time Frame
at four weeks post-injection
Title
(4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method)
Time Frame
at four weeks post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult between ages 18 and 75 years All patients, diagnosed of essential blepharospasm, with Grade 2~4 of Severity of Spmasm (by Scott's Method) Exclusion Criteria: Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy Patients with hypersensitivity history to botulinum toxin products previously Patients with secondary blepharomspasm Patients with hemifacialspasm Patients with treatment following drugs ; Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa Patients with previous injection of other botulinum toxin products in 3 months Patients with any other significant neuromuscular disease like Myasthenia gravis Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Duck Kim, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cha Hospital
City
Bundang
Country
Korea, Republic of
Facility Name
Seoul National University Hospital - Bundang
City
Bundang
Country
Korea, Republic of
Facility Name
Youngnam University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kim's eye hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University, Seoul, St.Mary's hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The catholic university, Yeouido, St. Mary's hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeonsei University, Severance hospital - Gangnam
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm

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