Ampicillin for DYT-1 Dystonia Motor Symptoms
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 7 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | December 2016 |
| Contact: | Kyle H Rizer, B.A. |
| Email: | kyle.rizer@neurology.ufl.edu |
| Phone: | 352-294-5194 |
A Pilot, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Determine the Safety and Efficacy of Ampicillin in Treating Primary Dystonia Symptoms
The purpose of this study is to evaluate if the antibiotic Ampicillin is safe and tolerated
in patients that have generalized dystonia caused by the DYT-1 gene mutation, as compared to
patients treated with a placebo. A placebo is a pill that looks and tastes the same as the
real drug, but without the active ingredient. The second objective of this study is to
determine if dystonia symptoms improve while on the study drug.
in patients that have generalized dystonia caused by the DYT-1 gene mutation, as compared to
patients treated with a placebo. A placebo is a pill that looks and tastes the same as the
real drug, but without the active ingredient. The second objective of this study is to
determine if dystonia symptoms improve while on the study drug.
This is a double-blinded and randomized drug study: neither the patient nor the investigator
know if patients are taking study drug (Ampicillin) or placebo.
Three study visits will include neurological exams, review of medical history, genetic test
results and video-taped BFM-DRS motor scales. Patients will receive medication during
baseline visit, consisting of either Ampicillin drug or placebo, which will be consumed
twice daily for 28 days. Following a washout period (no drugs) of 7 days, patient will
return to clinic for second study visit and receive second set of medication (placebo -vs-
Ampicillin). Medication will be consumed twice daily for 28 days, with patient returning to
clinic after a washout period of 7 days for final study visit in clinic.
know if patients are taking study drug (Ampicillin) or placebo.
Three study visits will include neurological exams, review of medical history, genetic test
results and video-taped BFM-DRS motor scales. Patients will receive medication during
baseline visit, consisting of either Ampicillin drug or placebo, which will be consumed
twice daily for 28 days. Following a washout period (no drugs) of 7 days, patient will
return to clinic for second study visit and receive second set of medication (placebo -vs-
Ampicillin). Medication will be consumed twice daily for 28 days, with patient returning to
clinic after a washout period of 7 days for final study visit in clinic.
Inclusion Criteria:
- DYT-1 dystonia, confirmed by genetic testing
- Between ages of 7 and 80 years
- BFM-DRS score greater than 6
Exclusion Criteria:
- Negative DYT-1 dystonia gene test
- Allergy to penicillins or cephalosporins
- Concurrent bacterial, viral or fungal infection at time of enrollment
- Pregnancy
- Inability to follow study protocol
- Lactose intolerance (placebo contains lactose powder)
We found this trial at
1
site
Gainesville, Florida 32607
Principal Investigator: Irene Malaty, M.D.
Phone: 352-294-5194
Click here to add this to my saved trials
