Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

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

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.

Study Overview

• Status: Completed
• Conditions: Dystonia, Focal
• Intervention / Treatment: Dietary supplement: Zinc Acetate; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zinc, then placebo; Participants first received oral zinc acetate 50 mg tab each day for 7 days before scheduled BoNT injection. 3 months later participants received oral placebo (matching oral zinc) tablet each day for 7 days before scheduled BoNT injection.	Dietary supplement: Zinc Acetate; 50 mg tablet; Dietary supplement: Placebo; Zinc Acetate matched placebo tablet
Experimental: placebo, then zinc; Participants first received placebo tablet (matching oral zinc) each day for 7 days before scheduled BoNT injection. 3 months later participants received oral zinc acetate 50 mg tablet each day for 7 days before scheduled BoNT injection.	Dietary supplement: Zinc Acetate; 50 mg tablet; Dietary supplement: Placebo; Zinc Acetate matched placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change	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	End of study, week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	Unstructured interview soliciting side-effects in the interval since prior BoNT injection	At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Padraig E O'Suilleabhain, MD, UTSW

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): October 31, 2014
• Study Completion (Actual): October 31, 2014

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders
• Other Study ID Numbers: STU-082021-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No