Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease - Full Text View

Sponsor:	University of South Florida
Information provided by:	University of South Florida
ClinicalTrials.gov Identifier:	NCT00584025

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Drug: levetiracetam Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levetiracetam

U.S. FDA Resources

Further study details as provided by University of South Florida:

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:	20
Study Start Date:	December 2007
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Keppra IV	Drug: levetiracetam 100 - 500mg IV q 15 min
Placebo Comparator: 2 Placebo	Drug: Placebo Placebo equivalent of 100 - 500 mg levetiracetam IV q 15 min

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584025

Locations

United States, Florida
University of South Florida
Tampa, Florida, United States, 33612

Sponsors and Collaborators

University of South Florida

Investigators

Principal Investigator:

Theresa A Zesiewicz, MD

University of South Florida

More Information

No publications provided

Responsible Party:	Theresa Zesiewicz, MD, University of South Florida
ClinicalTrials.gov Identifier:	NCT00584025 History of Changes
Other Study ID Numbers:	5
Study First Received:	December 21, 2007
Last Updated:	June 2, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of South Florida:

Parkinson's disease
dyskinesia
levetiracetam
keppra

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Etiracetam

Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012