Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

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.

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Key information

Conditions

Dystonia, Focal Central Nervous System Diseases Dystonic Disorders Movement Disorders Nervous System Diseases

Age range

18 month–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc acetate

Dietary Supplement

50 mg tablet

Placebo

Dietary Supplement

Zinc Acetate matched placebo tablet

Primary outcomes

Patient Global Impression of Change

Time frame: End of study, week 48

Patient selects one of three options: My response to BoNT injection with bottle A tablets was overall better than with bottle B tablets; My response to BoNT injection with bottle B tablets was overall better than bottle A tablets; or Neither BoNT injection with bottle A or with bottle B tablets was overall better than the other

Secondary outcomes

Number of participants with treatment-related adverse events

Time frame: At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo

Unstructured interview soliciting side-effects in the interval since prior BoNT injection

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Oral Zinc Supplementation to Enhance Effects of Botulinum Neurotoxin Injection: an n of 1 Study

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Oct 27, 2021
Registry last updated: Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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