Istradefylline Effect Protocol on Parkinson's Disease Tremor

Last updated: March 11, 2025
Sponsor: Georgetown University
Overall Status: Completed

Phase

4

Condition

Dystonia

Treatment

Istradefylline Pill

Clinical Study ID

NCT05885360
STUDY00005472
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 BrainBank 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, orproprioceptive dysfunction

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

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

  • 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

Exclusion Criteria:

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

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

  • Moderate to severe dyskinesia is defined as:

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

  • Severe: Dyskinesia impacts activities to the point that the patient usuallydoes not perform most activities or participate in most social activitiesduring 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 theNeuropsychiatric 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

Study Design

Total Participants: 27
Treatment Group(s): 1
Primary Treatment: Istradefylline Pill
Phase: 4
Study Start date:
January 20, 2023
Estimated Completion Date:
February 21, 2025

Study Description

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 suboptimal 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.

Based on data from an early experience limited data set within our clinical practice of patients taking Istradefylline, the investigator noted improvement in motor symptoms on PDRS-III. The investigator evaluated the degree of tremor with a tremor quantifying software before and after 8 weeks of therapy. Tremor amplitude, frequency and severity improved in the first two patients based on said parameters.

Secondary analysis in week 24 will include all aforementioned assessments. The investigator will compare their score and results before and after the medication.

The therapeutic intervention will consist of evaluating the effect of the addition of Istradefylline 40 mg daily (after two weeks of Istradefylline 20 mg daily) in patients already on levodopa and other anti- parkinsonian treatments. Patients will be screened based on inclusion and exclusion criteria. Enrolled patients will need to be on a stable regimen of all their concomitant medications for at least 30 days prior to baseline visit. All PD concomitant medications are allowable. Participants must also have a MOCA (Montreal Cognitive Assessment) of 22 or greater, and the absence of a diagnosis of dementia.

Tremor score will be clinically defined by the presence of a sum score of at least 8 of 32 of the MDS-UPDRS tremor items 16, 20, and 21 (referred to as tremor score). The generation of this sum score is based on the validity of the MDS-UPDRS regarding tremor, 19 and the clinical experience, that the MDS-UPDRS tremor items reflect different but similarly important aspects of Parkinsonian tremor, including the impairment of activities of daily living by tremor.

Connect with a study center

  • Georgetown University Hospital

    McLean, Virginia 22101
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.