Dystonia, Focal
Conditions
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.
Interventions
DIETARY_SUPPLEMENTZinc Acetate
50 mg tablet
DIETARY_SUPPLEMENTPlacebo
Zinc Acetate matched placebo tablet
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pharmacy prepares vials labeled A and B, and reveals code to PI after data lock
Intervention model description
Single site randomized placebo controlled trial, cross-over
Eligibility
Sex/Gender
ALL
Age
18 Months to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Unstructured interview soliciting side-effects in the interval since prior BoNT injection |
Outcome results
None listed