Istradefylline Effect Protocol on Parkinson's Disease Tremor

NCT05885360 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY00005472
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Tremor

Outcome Measures

Primary Outcomes (1)

• To observe the effect of Istradefylline on tremor in PD patients.

  · Evaluation of changes in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III tremor score ·· Evaluation of changes in the Movement Disorders Society - United Parkinson's Disease Rating Scale part III tremor score, with the minimum value being 0 and the maximum value being 4 for each sub-scale (rest, kinetic and postural), with a higher score signifying a worse outcome.

  8 weeks

Secondary Outcomes (7)

• To evaluate the changes in MDS-UPDRS part I (non-motor) in PD patients with tremor.

  24 weeks

• To evaluate the changes in MDS-UPDRS II motor symptoms in PD patients with tremor.

  24 weeks

• To evaluate the changes in cognition, mood and behavior in Parkinson's disease patients treated with Istradefylline.

  24 weeks

• To evaluate the the Geriatric depression scale (GDS) in PD patients with tremor.

  24 weeks

• To evaluate the effect of Istradefylline on activities of daily living in PD patients with tremor.

  24 weeks

Study Arms (1)

Istradefylline 20 and 40 mg

EXPERIMENTAL

The study intervention will be to add 20 mg Istradefylline for 2 weeks, following which the dose will be increased to 40 mg daily for the remainder of the 24 weeks.

Drug: Istradefylline Pill

Interventions

Istradefylline Pill DRUG

Istradefylline targets adenosine A2A receptors in the basal ganglia, by inhibiting the indirect pathway It is an adjunctive treatment to carbidopa-levodopa indicated to improve "on" time and decrease off time.

Also known as: NOURIANZ

Istradefylline 20 and 40 mg

Eligibility Criteria

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

You may qualify if:

• · 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
• 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

You may not qualify if:

• · 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

Sponsors & Collaborators

• Georgetown University: lead
• Kyowa Kirin, Inc.: collaborator

Study Sites (1)

Georgetown University Hospital

McLean, Virginia, 22101, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor

Interventions

istradefylline

Condition Hierarchy (Ancestors)

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

Study Officials

• Fernando Pagan

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: June 1, 2023
• Study Start: January 20, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 21, 2025
• Last Updated: March 13, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)