Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
2 participants
INTERVENTIONAL
2011-09-30
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ampicillin
Patients who are randomly selected to receive the active drug will receive Ampicillin (2mg daily for adults and 1 mg daily for children).
Ampicillin
Ampicillin will be given in capsule form. Dosage will be 2 mg daily for adults and 1 mg daily for children. One capsule will be taken each day for 28 consecutive days. After the first 28 days, there will be a 7 day 'washout' period during which no capsules are taken. Following the 'washout' period, another 28-day supply of Ampicillin will be given to the patient, to be taken in the same manner as described above.
Placebo
Patients who are randomly selected to receive the placebo will be given a sugar pill that resembles the active drug.
Sugar pill
The sugar pill will be given in capsule form. Dosage will be 2 mg daily for adults and 1 mg daily for children. One capsule will be taken each day for 28 consecutive days. After the first 28 days, there will be a 7 day 'washout' period during which no capsules are taken. Following the 'washout' period, another 28-day supply of the sugar pill will be given to the patient, to be taken in the same manner as described above.
Interventions
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Ampicillin
Ampicillin will be given in capsule form. Dosage will be 2 mg daily for adults and 1 mg daily for children. One capsule will be taken each day for 28 consecutive days. After the first 28 days, there will be a 7 day 'washout' period during which no capsules are taken. Following the 'washout' period, another 28-day supply of Ampicillin will be given to the patient, to be taken in the same manner as described above.
Sugar pill
The sugar pill will be given in capsule form. Dosage will be 2 mg daily for adults and 1 mg daily for children. One capsule will be taken each day for 28 consecutive days. After the first 28 days, there will be a 7 day 'washout' period during which no capsules are taken. Following the 'washout' period, another 28-day supply of the sugar pill will be given to the patient, to be taken in the same manner as described above.
Eligibility Criteria
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Inclusion Criteria
* Between ages of 7 and 80 years
* BFM-DRS score greater than 6
Exclusion Criteria
* 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)
7 Years
80 Years
ALL
No
Sponsors
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Tyler's Hope for a Dystonia Cure, Inc
UNKNOWN
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Irene Malaty, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States
Countries
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Other Identifiers
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301-2011
Identifier Type: -
Identifier Source: org_study_id
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