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

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Brief Title

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

Official Title

Double-Blind, Randomized, Phase 3, Comparative Study of a New Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm

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.
    

Detailed Description

      Severity of spasm was graded clinically from grade 0 to 4. Primary efficacy outcome was
      assessed as the number (%) of patients with improved SS of more than 1 score at 4 weeks
      post-injection. Secondary efficacy outcome measures included the change in scores from
      baseline on the SS, closing force of eyelids, and functional visual status at 4 weeks
      post-injection. The duration of action (days), the time interval between injection and the
      moment that the patient felt the need for retreatment were also assessed as secondary
      efficacy outcomes.

      The number (%) of patients with improvement of SS (primary efficacy outcome) and the change
      in scores from baseline at 4 weeks post-injection on the severity of spasm, closing force of
      eyelids, and functional visual status scores were not different between the KbtxA and Botox
      groups in the analysis of both the ITT and PP populations. Also, the duration of action was
      similar following KbtxA and Botox injections (two sample t-test, p=0.835). For the
      non-inferiority trial on primary efficacy outcome, KbtxA was not inferior to Botox in either
      the ITT or PP populations, as the lower limit of the 95% confidence interval (-1.76% for ITT,
      -1.64% for PP) was over the -15% threshold.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Blepharospasm

Intervention

Korean Botulinum toxin type A (KbtxA) and Botox injection

Study Arms / Comparison Groups

 1
Description:  Korean botulinum toxin A treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

October 2005

Completion Date

August 2006

Primary Completion Date

February 2006

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  Patients were not eligible for inclusion in the study if they

               -  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.

          -  In addition, patients who had shown hypersensitivity to BTX-A previously were not
             eligible for inclusion in the study.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Sang Y Lee, MD, phD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT00682760

Organization ID

Meditoxin_Botox

Secondary IDs

Meditoxin-05-01


Study Sponsor

Pacific Pharmaceuticals


Study Sponsor

Sang Y Lee, MD, phD, Principal Investigator, Yonsei University


Verification Date

May 2008