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Completed

NCT Number: NCT01791881

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

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

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Key information

Conditions

Essential Blepharospasm Benign essential blepharospasm

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hugeltox

Drug

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

Botulinum toxin type A(Botox®)

Drug

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

Primary outcomes

  1. 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 outcomes

  1. (1) Duration of action days

    Time frame: 6 months

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

    Time frame: at four weeks post-injection

  3. (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. (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

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 15, 2013
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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