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Ampicillin for DYT-1 Dystonia Motor Symptoms

Information source: University of Florida
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: DYT-1; Dystonia

Intervention: Ampicillin (Drug); Sugar pill (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Ramon L Rodriguez, M.D., Principal Investigator, Affiliation: University of Florida

Overall contact:
Kyle H Rizer, B.A., Phone: 352-294-5194, Email: kyle.rizer@neurology.ufl.edu

Summary

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.

Clinical Details

Official title: A Pilot, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Determine the Safety and Efficacy of Ampicillin in Treating Primary Dystonia Symptoms

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Safety and tolerability of Ampicillin in treating DYT-1 dystonia

Secondary outcome: Burke-Fahn Marsden Dystonia Rating Scale (BFM-DRS)

Detailed description: 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.

Eligibility

Minimum age: 7 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Kyle H Rizer, B.A., Phone: 352-294-5194, Email: kyle.rizer@neurology.ufl.edu

UF Center for Movement Disorders and Neurorestoration, Gainesville, Florida 32607, United States; Recruiting
Kyle H Rizer, B.A., Phone: 352-294-5194, Email: kyle.rizer@neurology.ufl.edu
Stacy S Merritt, MA, Phone: 352-273-5614, Email: stacy.merritt@neurology.ufl.edu
Ramon L. Rodriguez, M.D., Principal Investigator
Additional Information

Starting date: September 2011
Last updated: October 23, 2012

Page last updated: February 07, 2013

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