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

NCT00584025 | Withdrawn Phase 4

• 1 other identifier: 5
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; dyskinesia; levetiracetam; keppra

Outcome Measures

Primary Outcomes (1)

• Abnormal Involuntary Movements Scale (AIMS)

  15 minutes

Secondary Outcomes (1)

• Rush Dyskinesia Rating Scale

  15 minutes

Study Arms (2)

1

EXPERIMENTAL

Keppra IV

Drug: levetiracetam

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

levetiracetam DRUG

100 - 500mg IV q 15 min

1

Placebo DRUG

Placebo equivalent of 100 - 500 mg levetiracetam IV q 15 min

2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Theresa A Zesiewicz, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (1)