CompletedNot Applicable

Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

54 participantsStarted 2013-01-01

Plain-language summary

Botulinum neurotoxin (BoNT) is injected into muscles for treatment of dystonia. BoNTs are zinc proteases, and their enzymatic effect is reduced in the setting of low zinc. The study hypothesis is that a large enough fraction of unselected dystonia patients receiving BoNT injection have suboptimal zinc concentration in their tissues, and will experience improved response to BoNT if the injection is preceded by oral zinc supplementation (OZS). OZS consists of 50 mg of zinc acetate oral tablet each day for 7 days before injection. This is a double blind placebo controlled cross-over study, randomized order placebo and OZS, in patients at a neurology clinic on stable dose of BoNT.

Who can participate

Age range18 Months – 80 Years

SexALL

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

Inclusion Criteria: * Patients of the PI * Age 18-80 * Male or female * With an approved indication for BoNT such as dystonia or hemifacial spasm * Have received either two or three BoNT injection cycles within the prior 8 months * Prior two injection cycles length differed by no more than 2 weeks * Prior two injection cycles used same brand of BoNT and similar dose within 15% Exclusion Criteria: * Concommitant use of penicillamine or cisplatin

What they're measuring

Patient Global Impression of Change

Timeframe: End of study, week 48

Trial details

NCT IDNCT05095493

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10-31

View on ClinicalTrials.gov More Dystonia, Focal trials