Dystonia, FocalNCT05095493
Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response
A study testing Zinc Acetate in people with Dystonia, Focal, run by University of Texas Southwestern Medical Center.
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… Read more about this study
- Who is it for?
- Ages 18 months to 80 years
- Conditions the study is for
- Dystonia, Focal
- What is being tested?
- Zinc Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Concommitant use of penicillamine or cisplatin
About this study
Official title: 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.
- Conditions
- Dystonia, Focal
- Being tested
- Zinc Acetate, Placebo
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc AcetateDietary supplement
50 mg tablet
PlaceboDietary supplement
Zinc Acetate matched placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Zinc Acetate; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of study, week 48
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Unstructured interview soliciting side-effects in the interval since prior BoNT injection
Measured: At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Jan 2013
- Primary completion31 Oct 2014
- Study completion31 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystonia, FocalStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single site randomized placebo controlled trial, cross-over
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Padraig O'Suilleabhain, University of Texas Southwestern Medical Center
- Investigators
- Padraig E O'Suilleabhain, MD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095493
- Sponsor's protocol ID
- STU-082021-075
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Zinc Supplementation to Enhance Effects of Botulinum Neurotoxin Injection: an n of 1 Study
- ClinicalTrials.gov ID
- NCT05095493
- Acronym / sponsor ID
- STU-082021-075
- Conditions
- Dystonia, Focal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Oct 2014 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single site randomized placebo controlled trial, cross-over
| Arm | Type | Receives |
|---|---|---|
| zinc, then placebo | Experimental | Dietary Supplement: Zinc Acetate, Dietary Supplement: PlaceboParticipants 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. |
| placebo, then zinc | Experimental | Dietary Supplement: Zinc Acetate, Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Concommitant use of penicillamine or cisplatin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Acetate50 mg tablet | Dietary supplement | placebo, then zinc, zinc, then placebo |
| PlaceboZinc Acetate matched placebo tablet | Dietary supplement | placebo, then zinc, zinc, then placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Padraig E O'Suilleabhain, MD principal investigator
UTSW
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Acetate in people with Dystonia, Focal, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Change (time frame: End of study, week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.