Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm

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Brief Title

Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm

Official Title

Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm: a Randomized, Triple-blind, Placebo-controlled, Cross-over Clinical Trial

Brief Summary

      A triple-masked placebo-controlled trial assessing the efficacy and safety of pretarsal
      versus preseptal botulinum toxin for patients with eyelid spasm. The investigators
      hypothesize injection of botulinum toxin into the pretarsal orbicularis oculi muscle will
      have greater clinical efficacy, better measured quality of life, fewer complications, and
      better cost effectiveness in comparison to a preseptal pattern of injection.
    

Detailed Description

      The study design is a prospective, randomized, triple-blinded placebo controlled crossover
      trial. A computer-generated list of random numbers will be used for allocation of patients.
      The patients, treating physicians, and outcome assessors will be masked to the contents of
      the Botulinum Toxin Type A (BtA) and placebo syringe injections. The placebo will consist of
      vehicle only, which is the same sterile normal 0.9% saline used in reconstitution of the BtA.
      At month 6, each group will crossover and receive the alternative intervention. The primary
      outcome measure (JRS severity) will be the change as measured 1 month after the second cycle
      of each intervention. Secondary outcome measures include the TWSTRS (clinical response),
      Blepharospasm Disability Index (BSDI), CDQ-24 (quality of life), VAS (pain), and GAS (global)
      scores and incidence of side effects. The investigators plan to compare the outcome measures
      between groups with linear mixed models allowing for the crossover design.

      Data will be collected at each of the injection visits and at both of the clinical activity
      visits. The data will be processed by the research assistant and analysed by the project
      biostatistician. The investigators plan to compare the primary (JRS) and secondary outcome
      measures (TWSTRS, BSDI, CDQ-24, VAS, and GAS scores) between the Preseptal-pretarsal (Group
      1) and the Pretarsal-preseptal (Group 2) allowing for the crossover design. Specifically, the
      investigators will use a 2-sample t-test to compare all values of the JRS in group 1 with all
      the values of the JRS in group 2. This will allow the investigators to determine whether
      carryover effects are present, and the investigators have specified a 3-month washout period
      between the first and second round of injections to minimise the chance of carryover effects.
      If carryover effects are present, the investigators will allow for these in further analysis.
      The investigators will then use linear mixed models to estimate the difference between the
      two interventions, allowing for the repeated measures, and if necessary for carryover
      effects. In secondary analyses, the investigators will evaluate the proportion of patients
      with relief of spasm, improvement in quality of life, and incidence of side effects,
      including eyelid ptosis measurements between the two interventions, using logistic
      regression. P values of 0.05 or less will be considered statistically significant. All
      analyses will be conducted under the principle of Intention to Treat, using multiple
      imputation to account for any missing data and to include all randomized patients in
      analysis.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Jankovic Rating Scale (JRS)

Secondary Outcome

 Toronto (TWSTRS)

Condition

Blepharospasm

Intervention

Botulinum Toxin Type A 100Unit/Vial (Product)

Study Arms / Comparison Groups

 Preseptal-pretarsal
Description:  The Preseptal-pretarsal group will receive injections of Botulinum Toxin Type A 100Unit/Vial (Product) in the preseptal site (Injection pattern A) and Saline Solution for Injection (placebo control) in the pretarsal site for 2 cycles at 3 months apart. Both groups will crossover and receive the alternative intervention. Hence in the second half of the trial, the Preseptal-pretarsal group will be injected with BtA in Pattern B and Pretarsal-preseptal group will receive Pattern A.

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

100

Start Date

July 1, 2015

Completion Date

February 20, 2019

Primary Completion Date

October 31, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Patients over 18 years-of-age

          -  Clinical diagnosis eyelid dystonia, consisting of either blepharospasm or hemifacial
             spasm

          -  Patient wish to have treatment with botulinum toxin type A (BtA).

        Exclusion Criteria:

          -  Patients unable to express their symptoms or history to the extent that they are not
             able to complete the study questionnaires, such as those suffering from dementia.

          -  Existence of potential contraindications to BtA treatment:

               -  Pregnancy

               -  Breastfeeding

               -  Prior allergic reaction

               -  Active infection or inflammation in the treatment area

               -  Neuromuscular and peripheral neuropathic disease

               -  Concomitant aminoglycoside therapy

          -  Patients with poor or unstable general health with activities of daily living severely
             affected by non-dystonia confounding factors, such as hospitalized or bed bound
             patients.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Marcus M Marcet, MD, , 



Administrative Informations


NCT ID

NCT03508882

Organization ID

HMRF Project No.: 12133171

Secondary IDs

Protocol : MMBT; v1.3;1Mar16

Responsible Party

Principal Investigator

Study Sponsor

The University of Hong Kong

Collaborators

 Food and Health Bureau, Hong Kong

Study Sponsor

Marcus M Marcet, MD, Principal Investigator, The University of Hong Kong


Verification Date

April 2019