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Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

Primary Purpose

Dystonia, Focal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zinc Acetate
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystonia, Focal

Eligibility Criteria

18 Months - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    zinc, then placebo

    placebo, then zinc

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Number of participants with treatment-related adverse events
    Unstructured interview soliciting side-effects in the interval since prior BoNT injection

    Full Information

    First Posted
    October 1, 2021
    Last Updated
    October 26, 2021
    Sponsor
    University of Texas Southwestern Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05095493
    Brief Title
    Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response
    Official Title
    Oral Zinc Supplementation to Enhance Effects of Botulinum Neurotoxin Injection: an n of 1 Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2013 (Actual)
    Primary Completion Date
    October 31, 2014 (Actual)
    Study Completion Date
    October 31, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dystonia, Focal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Single site randomized placebo controlled trial, cross-over
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Pharmacy prepares vials labeled A and B, and reveals code to PI after data lock
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    zinc, then placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    placebo, then zinc
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Zinc Acetate
    Intervention Description
    50 mg tablet
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Zinc Acetate matched placebo tablet
    Primary Outcome Measure Information:
    Title
    Patient Global Impression of Change
    Description
    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
    Time Frame
    End of study, week 48
    Secondary Outcome Measure Information:
    Title
    Number of participants with treatment-related adverse events
    Description
    Unstructured interview soliciting side-effects in the interval since prior BoNT injection
    Time Frame
    At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Months
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Padraig E O'Suilleabhain, MD
    Organizational Affiliation
    UTSW
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

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