Trial record 13 of 28 for:    Benign Essential Blepharospasm

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hugel
ClinicalTrials.gov Identifier:
NCT01791881
First received: February 13, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
The catholic university, Yeouido, St. Mary's hospital
Seoul, Korea, Republic of
Chungang University Hospital
Seoul, Korea, Republic of
Yeonsei University, Severance hospital - Gangnam
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
Sponsors and Collaborators
Hugel
Investigators
Study Chair: Yoon-Duck Kim, M.D., Ph.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Hugel
ClinicalTrials.gov Identifier: NCT01791881     History of Changes
Other Study ID Numbers: HG-06-01
Study First Received: February 13, 2013
Last Updated: February 13, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014