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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 November 2021
• Main ID: NCT00584025
• Date of registration: 21/12/2007
• Prospective Registration: No
• Primary sponsor: University of South Florida
• Public title: Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease
• Date of first enrolment: December 2007
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00584025
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Theresa A Zesiewicz, MD
• Affiliation: University of South Florida

Key inclusion & exclusion criteria

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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: levetiracetam

Primary Outcome(s)

Abnormal Involuntary Movements Scale (AIMS) [Time Frame: 15 minutes]

Secondary Outcome(s)

Rush Dyskinesia Rating Scale [Time Frame: 15 minutes]

Secondary ID(s)

5

Source(s) of Monetary Support

Please refer to primary and secondary sponsors