Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease
This study has been withdrawn prior to enrollment.
(Study withdrawn due to personnel limitations.)
Information provided by:
University of South Florida
First received: December 21, 2007
Last updated: June 2, 2008
Last verified: June 2008
The primary purpose of this study is to characterize the acute anti-dyskinetic properties of intravenous levetiracetam in Parkinson's disease patients who have been optimized on antiparkinsonian medication. The secondary objective is to study the effect of intravenous LEV on additional motor and cognitive symptoms of PD.
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Outcome Measures:
- Abnormal Involuntary Movements Scale (AIMS) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rush Dyskinesia Rating Scale [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||August 2008 (Final data collection date for primary outcome measure)
100 - 500mg IV q 15 min
Placebo Comparator: 2
Placebo equivalent of 100 - 500 mg levetiracetam IV q 15 min
|Ages Eligible for Study:
||30 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
- Age 30 years to 80 years.
- Dyskinesias with a minimum severity equal to a rating of 10 or higher on the AIMS rating scale at baseline.
- Dyskinesias at least moderately disabling (historical information from item 33 of UPDRS).
- Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
- Women of child-bearing potential must use a reliable method of contraception and must be willing to perform a pregnancy test paid for and provided by Dr. Zesiewicz and the USF Medical Clinic. There must be a negative result before entry into the study.
- Any illness that in the investigator's opinion preclude participation in this study. This includes patients with unstable disease and those PD patients who can not tolerate IV infusion.
- Pregnant or lactating women. Pregnancy will not be allowed whether as a pre-existing condition or a positive result on the pregnancy test in the screening process. Lactation includes any woman wanting to participate who is currently breast-feeding.
- Patients may not be dual enrolled to another research study requiring the patient to sign informed consent.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score of less than 20).
- Legal incapacity or limited legal capacity.
- Presence of severe renal disease (BUN 50% greater than normal). Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 months; patients with BUN 50% greater than normal (5 to 20 mg/ d L) or creatinine 50% greater than normal (0 .7 and 1.4 mg/ d L) will be excluded. Labs will be requested from PCP.
- Concomitant or prior therapy with the following treatments: neuroleptics, metoclopramide, domperidone (in doses >60mg/day), azole antifungals (e.g. ketoonazole), etomidate, ciprofloxacin, fluvoxamine, cimetidine, fludrocortizone, encainide, flecainide, mexiletine, propafenone, guanoxane, maprotiline, antidepressants on doses higher than the maximum approved daily dose for outpatients, intermittent therapy with oral corticoids.
- Patients who are not fluent in English.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584025
|University of South Florida
|Tampa, Florida, United States, 33612 |
University of South Florida
||Theresa A Zesiewicz, MD
||University of South Florida
No publications provided
||Theresa Zesiewicz, MD, University of South Florida
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 21, 2007
||June 2, 2008
||United States: Institutional Review Board
Keywords provided by University of South Florida:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 11, 2014
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Agents
Physiological Effects of Drugs