- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433757
Ampicillin for DYT-1 Dystonia Motor Symptoms
A Pilot, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Determine the Safety and Efficacy of Ampicillin in Treating Primary Dystonia Symptoms
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32607
- UF Center for Movement Disorders and Neurorestoration
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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 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.
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PLACEBO_COMPARATOR: Placebo
Patients who are randomly selected to receive the placebo will be given a sugar pill that resembles the active drug.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of Ampicillin in treating DYT-1 dystonia
Time Frame: 70 days
|
The primary objective of this study is to evaluate the safety and tolerability of treating DYT-1 dystonia with the use of ampicillin as compared to placebo.
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70 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burke-Fahn Marsden Dystonia Rating Scale (BFM-DRS)
Time Frame: 70 days
|
We will determine if there is a reduction in Burke-Fahn Marsden Dystonia Rating Scale motor scores at the end of the study period and compare with the placebo treated group.
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70 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 301-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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