Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm

NCT00682760 | Completed Phase 3 DMC

• 2 other identifiers: Meditoxin_BotoxMeditoxin-05-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of Korean botulinum toxin A (KbtxA, Pacific Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we performed a double-blinded, randomized, comparative trial comparing KbtxA and Botox for treatment of blepharospasm in 60 patients of the intention to treat population and 52 patients (26 patients from each group) of the per protocol population. The improvement of severity of spasm (SS) at 4 weeks post-injection as a primary efficacy outcome, qualifying non inferiority to the control group, Changes in eyelid closure force (CF) and functional visual status (FVS) after injection for secondary efficacy outcomes, and adverse effects for safety evaluation. Improvement of SS was noted in 90.3% of the KbtxA group and 86.2% of the Botox group. There were no significant differences between treatment groups in the changes of CF and FVS after injection (p\>0.05). Adverse effects developed in 16.1% of the KbtxA group and 27.6% of the Botox group, but no serious adverse events were found in either group. KbtxA was not inferior to Botox in treatment efficacy and was clinically safe with no serious adverse effects when used to treat essential blepharospasm.

Conditions

Blepharospasm

Keywords

Botulinum Toxin Type A; Blepharospasm

Outcome Measures

Primary Outcomes (1)

• The improvement of severity of spasm at 4 weeks post-injection as a primary efficacy outcome, qualifying non inferiority to the control group

  at 4 weeks post-injection

Secondary Outcomes (1)

• Changes in eyelid closure force and functional visual status after injection for secondary efficacy outcomes

  at 4 weeks post-injection

Study Arms (2)

1

ACTIVE COMPARATOR

Korean botulinum toxin A treatment

Drug: Korean Botulinum toxin type A (KbtxA) and Botox injection

2

PLACEBO COMPARATOR

Botox treatment

Drug: Korean Botulinum toxin type A (KbtxA) and Botox injection

Interventions

Korean Botulinum toxin type A (KbtxA) and Botox injection DRUG

Each vial of Botox and KbtxA contained 100 U of BTX-A in a sterile vacuum-derived form without preservatives. Each vial of KbtxA was identical to the placebo (Botox) vial, and all vials were reconstituted with 2.0 mL of 0.9% sterile nonpreserved saline solution to a final dilution of 5 U /0.1 mL. The dose of BTX-A per injection site was 2.5 U to 5 U, and the location, number of injection sites. Using a 30-gauge needle, injections were angled away from the center of lid to reduce the risk of spread into the levator muscle. Injection sites include the upper medial and lateral eyelid margins, lower lateral lid margins, and above the eyebrow.

Also known as: arm1 ; Meditoxin or Neuronox

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients, aged between 18 and 75 years old, had confirmed diagnoses of bilateral essential blepharospasm.
• The patients were recruited from two botulinum toxin clinics (Yonsei University and Chung-Ang University, Seoul, Korea) from October 18, 2005 until February 21, 2006.

You may not qualify if:

• had undergone either myectomy or neurectomy
• had received anti-spastic, muscle relaxant medication within 1 month of study entry
• had been injected previously with BTX-A within 3 months of study entry
• had any muscle disorder
• Women with positive urine pregnancy test, or who were pregnant or lactating were also excluded from the study.

Sponsors & Collaborators

• Pacific Pharmaceuticals: lead

Study Sites (1)

Sang Yeul Lee

Seoul, 120-752, South Korea

Location

Related Publications (2)

• Stone AV, Ma J, Whitlock PW, Koman LA, Smith TL, Smith BP, Callahan MF. Effects of Botox and Neuronox on muscle force generation in mice. J Orthop Res. 2007 Dec;25(12):1658-64. doi: 10.1002/jor.20450.

  PMID: 17600825 BACKGROUND

• Yoon JS, Kim JC, Lee SY. Double-blind, randomized, comparative study of Meditoxin versus Botox in the treatment of essential blepharospasm. Korean J Ophthalmol. 2009 Sep;23(3):137-41. doi: 10.3341/kjo.2009.23.3.137. Epub 2009 Sep 8.

  PMID: 19794937 DERIVED

MeSH Terms

Conditions

Blepharospasm

Interventions

26S proteasome non-ATPase regulatory subunit 13; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Sang Y Lee, MD, phD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: October 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 22, 2008

Record last verified: 2008-05

Locations

KR (1)