Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00584025
Recruitment Status : Withdrawn (Study withdrawn due to personnel limitations.)
First Posted : January 2, 2008
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):
Theresa Zesiewicz, MD, University of South Florida

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Drug: levetiracetam Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Keppra IV
Drug: levetiracetam
100 - 500mg IV q 15 min
Placebo Comparator: 2
Drug: Placebo
Placebo equivalent of 100 - 500 mg levetiracetam IV q 15 min

Primary Outcome Measures :
  1. Abnormal Involuntary Movements Scale (AIMS) [ Time Frame: 15 minutes ]

Secondary Outcome Measures :
  1. Rush Dyskinesia Rating Scale [ Time Frame: 15 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
  2. Age 30 years to 80 years.
  3. Dyskinesias with a minimum severity equal to a rating of 10 or higher on the AIMS rating scale at baseline.
  4. Dyskinesias at least moderately disabling (historical information from item 33 of UPDRS).
  5. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
  6. 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:

  1. 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.
  2. 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.
  3. Patients may not be dual enrolled to another research study requiring the patient to sign informed consent.
  4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score of less than 20).
  5. Legal incapacity or limited legal capacity.
  6. 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.
  7. 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.
  8. Patients who are not fluent in English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00584025

United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Principal Investigator: Theresa A Zesiewicz, MD University of South Florida

Responsible Party: Theresa Zesiewicz, MD, Professor of Neurology, University of South Florida Identifier: NCT00584025     History of Changes
Other Study ID Numbers: 5
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Keywords provided by Theresa Zesiewicz, MD, University of South Florida:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs