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Istradefylline Effect Protocol on Parkinson's Disease Tremor

NCT05885360 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-03-13

No results posted yet for this 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.

Conditions

  • Parkinson Disease
  • Tremor

Interventions

DRUG

Istradefylline Pill

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.

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Fernando Pagan · Georgetown University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2024-02-23
Completion
2025-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05885360 on ClinicalTrials.gov