NCT01791881

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

February 13, 2013

Last Update Submit

February 13, 2013

Conditions

Essential Blepharospasm

Outcome Measures

Primary Outcomes (1)

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

    at 4 weeks post-injection

Secondary Outcomes (4)

  • (1) Duration of action days

    6 months

  • (2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status

    at four weeks post-injection

  • (3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method)

    at four weeks post-injection

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

    at four weeks post-injection

Study Arms (2)

Botulinum toxin type A(Botox®)

ACTIVE COMPARATOR

Botulinum toxin type A(Botox®)

Drug: HugeltoxDrug: Botulinum Toxin Type A(Botox®)

Botulinum toxin type A(Hugeltox)

EXPERIMENTAL

Botulinum toxin type A(Hugeltox)

Drug: HugeltoxDrug: Botulinum Toxin Type A(Botox®)

Interventions

HugeltoxDRUG

1.25U\~2.5U/site, Maximum dosage 12.5U\~60U/person

Botulinum toxin type A(Botox®)Botulinum toxin type A(Hugeltox)
Botulinum Toxin Type A(Botox®)DRUG

1.25U\~2.5U/site, Maximum dosage 12.5U\~60U/person

Botulinum toxin type A(Botox®)Botulinum toxin type A(Hugeltox)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Samsung medical Center

Seoul, Seoul, South Korea

Location

The Catholic University, Seoul, St.Mary's hospital

Seoul, Seoul, South Korea

Location

Cha Hospital

Bundang, South Korea

Location

Seoul National University Hospital - Bundang

Bundang, South Korea

Location

Youngnam University Hospital

Daegu, South Korea

Location

Chungang University Hospital

Seoul, South Korea

Location

Kim's eye hospital

Seoul, South Korea

Location

The catholic university, Yeouido, St. Mary's hospital

Seoul, South Korea

Location

Yeonsei University, Severance hospital - Gangnam

Seoul, South Korea

Location

MeSH Terms

Conditions

Benign essential blepharospasm

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Yoon-Duck Kim, M.D., Ph.D.

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

April 1, 2008

Primary Completion

May 1, 2009

Study Completion

July 1, 2009

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

KR(9)