CompletedPhase 4

Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm

100 participantsStarted 2015-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Jankovic Rating Scale (JRS)

Timeframe: The videos will be taken at the clinical activity visits (C1 and C2) will be scheduled for months 4 and 10. The primary outcome measure will consist of the change from C1 to C2.

Trial details

NCT IDNCT03508882

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-31