Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

Dystonia, Focal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095493
• Other study ID #: STU-082021-075
• Status: Completed
• Phase: N/A
• Start date: January 1, 2013
• Est. completion date: October 31, 2014

Study information

• Verified date: October 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 31, 2014
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Dystonia, Focal
• Dystonic Disorders

Intervention

Dietary Supplement:
• Zinc Acetate
50 mg tablet
• Placebo
Zinc Acetate matched placebo tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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