NCT05885360CompletedPhase 4
Istradefylline Effect Protocol on Parkinson's Disease Tremor
Istradefylline Effect on Parkinson's Disease Tremor, Motor Symptoms and Non-motor Symptoms
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 7 Feb 2023
- Start date
- 20 Jan 2023
- Primary completion date
- 23 Feb 2024
- Lead sponsor
- Georgetown University
- Diseases
- Parkinson disease
- NCT number
- NCT05885360
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 27
- From 20 Jan 2023 to the primary completion date, 23 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- · 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
Who the study is looking for
- · 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Georgetown University Hospital Coordinator of this site? Confirm its status | McLean | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.