Istradefylline Effect Protocol on Parkinson's Disease Tremor

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an investigator-initiated trial. In this 6-month open label, single arm, exploratory pilot study, the investigator intends to enroll a pilot sample of 25 patients with Parkinson's disease who are being started on the novel FDA approved medication "Istradefylline'' as an add on therapy for management of their motor symptoms (based on the judgment of the movement disorders specialist, if patients are in sub-optimal management of their symptoms on maximum tolerable dose of their dopaminergic medications). The investigator will evaluate their motor symptoms before starting the new medication, including their MDS-UPDRS total and MDS-UPDRS-III scores.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Kyowa Kirin, Inc.
• Treatments: Istradefylline

Criteria

Inclusion Criteria:

• · Written informed consent

• Capable of providing informed consent and complying with study procedures

• Clinical diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria which includes the following.

• Bradykinesia

• At least one of the following:

• Muscular righty

• 4-6 Hz rest tremor

• Postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction

• Must be on a stable regimen of all current concomitant medication, including carbidopa-levodopa for at least 30 days prior to baseline visit

• Participants also have a MOCA (Montreal Cognitive Assessment) score of 22 or greater

• Study subjects are willing to present for all study visits and take medication.

• The MDS-UPDRS I-III will be used to assess a baseline tremor score

Exclusion Criteria:

• · Diagnosis of dementia - defined by NIH as the loss of cognitive functioning such as thinking, remembering, and reasoning, to such an extent that it interferes with a person's daily life and activities.

• Parkinson's plus syndromes or any other disorder other than idiopathic Parkinson's disease

• Moderate to severe dyskinesia is defined as:

• Moderate: Dyskinesias impact on activity to the point that the patient usually does not perform some activities or does not usually participate in some social activities during dyskinetic episodes

• Severe: Dyskinesia impacts activities to the point that the patient usually does not perform most activities or participate in most social activities during dyskinetic episodes

• Patients with severe cardiac disease or congestive heart failure

• Severe uncontrolled orthostatic hypotension

• Psychosis or psychotic symptoms that would raise concern for safe use of IST, as indicated by domains A (delusions) and B (hallucinations) of the Neuropsychiatric Inventory (NPI), and defined as a score of ≥ 4 on either the A (frequency x severity) or B (frequency x severity) scales of the NPI

• Active neoplastic disorder

• Current treatment with strong CYP3A4 inhibitors

• Current treatment with strong CYP3A4 inducers