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| Name | Class |
|---|---|
| Kyowa Kirin, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the changes in MDS-UPDRS part I (non-motor) in PD patients with tremor. |
| 24 weeks |
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Inclusion Criteria:
· Written informed consent
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.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Pagan | Georgetown University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital | McLean | Virginia | 22101 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 10, 2026 | Mar 27, 2026 | 3 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C111599 | istradefylline |
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|
| 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. | - To evaluate the changes in cognition, mood and behavior in Parkinson's disease patients treated with Istradefylline by evaluating the change in score in the Geriatric depression scale (GDS), with a minimum score of 0 and a maximum score of 10, where a higher score signifies a worse outcome. | 24 weeks |
| To evaluate the effect of Istradefylline on activities of daily living in PD patients with tremor. | - To evaluate changes due to adjustments to individual concomitant medications in response to adverse events due to Istradefylline and changes in the Movement Disorders Society- United Parkinson's Disease Rating Scale Part III tremor score. | 24 weeks |
| To assess the utility of a tremor capturing application such as Mindsquare app. | - To assess the utility of a tremor capturing application (Mind-square) to measure tremor severity (amplitude as measured by the average displacement in the Z axis) | 24 weeks |
| To assess changes in motor impairment using the Right Eye eye- tracking technology. | - To assess changes in motor impairment using the Dynamic Vision test, a part of the Right Eye eye-tracking technology, to measure changes in pursuits, fixations and saccades eye movements, which a minimum score of 0 percentile and a maximum score of 100th percentile, with the higher score signifying a better outcome. | 24 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |