MedDataX Logo

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

NCT ID: NCT00584025

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Parkinson's disease dyskinesia levetiracetam keppra

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Keppra IV

Group Type EXPERIMENTAL

levetiracetam

Intervention Type DRUG

100 - 500mg IV q 15 min

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

levetiracetam

100 - 500mg IV q 15 min

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Theresa Zesiewicz, MD

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Theresa A Zesiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Florida

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5

Identifier Type: -

Identifier Source: org_study_id