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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Acetate | Dietary Supplement | 50 mg tablet |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Padraig E O'Suilleabhain, MD | UTSW | Principal Investigator |
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| ID | Term |
|---|---|
| D020821 | Dystonic Disorders |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019345 | Zinc Acetate |
| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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Single site randomized placebo controlled trial, cross-over
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Pharmacy prepares vials labeled A and B, and reveals code to PI after data lock
| Placebo |
| Dietary Supplement |
Zinc Acetate matched placebo tablet |
|
| D009930 |
| Organic Chemicals |