Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

NCT05095493 | Completed

• 1 other identifier: STU-082021-075
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dystonia, Focal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with treatment-related adverse events

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

Study Arms (2)

zinc, then placebo

EXPERIMENTAL

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; Dietary Supplement: Placebo

placebo, then zinc

EXPERIMENTAL

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; Dietary Supplement: Placebo

Interventions

Zinc Acetate DIETARY_SUPPLEMENT

50 mg tablet

placebo, then zinc; zinc, then placebo

Placebo DIETARY_SUPPLEMENT

Zinc Acetate matched placebo tablet

placebo, then zinc; zinc, then placebo

Eligibility Criteria

• Age: 18 Months - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• Concommitant use of penicillamine or cisplatin

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Dystonic Disorders

Interventions

Zinc Acetate

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Padraig E O'Suilleabhain, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy prepares vials labeled A and B, and reveals code to PI after data lock
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: Single site randomized placebo controlled trial, cross-over

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 27, 2021
• Study Start: January 1, 2013
• Primary Completion: October 31, 2014
• Study Completion: October 31, 2014
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share