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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791881
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
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.
Information provided by (Responsible Party):
Hugel
  Purpose
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

Condition Intervention Phase
Essential Blepharospasm Drug: Hugeltox Drug: Botulinum Toxin Type A(Botox®) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hugel:

Primary Outcome Measures:
  • 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 Measures:
  • (1) Duration of action days [ Time Frame: 6 months ]
  • (2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status [ Time Frame: at four weeks post-injection ]
  • (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 ]
  • (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 ]

Enrollment: 172
Study Start Date: April 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botulinum toxin type A(Botox®)
Botulinum toxin type A(Botox®)
Drug: Hugeltox
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Drug: Botulinum Toxin Type A(Botox®)
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Experimental: Botulinum toxin type A(Hugeltox)
Botulinum toxin type A(Hugeltox)
Drug: Hugeltox
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
Drug: Botulinum Toxin Type A(Botox®)
1.25U~2.5U/site, Maximum dosage 12.5U~60U/person

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01791881


Locations
Korea, Republic of
Cha Hospital
Bundang, Korea, Republic of
Seoul National University Hospital - Bundang
Bundang, Korea, Republic of
Youngnam University Hospital
Daegu, Korea, Republic of
Chungang University Hospital
Seoul, Korea, Republic of
Kim's eye hospital
Seoul, Korea, Republic of
Samsung medical Center
Seoul, Korea, Republic of
The Catholic University, Seoul, St.Mary's hospital
Seoul, Korea, Republic of
The catholic university, Yeouido, St. Mary's hospital
Seoul, Korea, Republic of
Yeonsei University, Severance hospital - Gangnam
Seoul, Korea, Republic of
Sponsors and Collaborators
Hugel
Investigators
Study Chair: Yoon-Duck Kim, M.D., Ph.D. Samsung Medical Center
  More Information

Responsible Party: Hugel
ClinicalTrials.gov Identifier: NCT01791881     History of Changes
Other Study ID Numbers: HG-06-01
First Submitted: February 13, 2013
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins
onabotulinumtoxinA
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