Parkinson DiseasePhase 4NCT05885360
Istradefylline Effect Protocol on Parkinson's Disease Tremor
A Phase 4 study testing Istradefylline Pill in people with Parkinson Disease and Tremor, run by Georgetown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Tremor
- What is being tested?
- Istradefylline Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 21 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- · 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
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- 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
Who cannot join
- · 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
McLean, Virginia, 22101
About this study
Official title: Istradefylline Effect on Parkinson's Disease Tremor, Motor Symptoms and Non-motor Symptoms
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.
Read the detailed 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.
- Conditions
- Parkinson Disease, Tremor
- Being tested
- Istradefylline Pill
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Istradefylline PillDrug
Also called NOURIANZ
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Istradefylline Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (7)
To evaluate the changes in MDS-UPDRS part I (non-motor) in PD patients with tremor.
- Evaluation of changes in MDS-UPDRS part I (non-motor)
- Evaluation of changes in Movement Disorders Society- United Parkinson's Disease Rating Scale Part I (non-motor) with a minimum score being 0 and a maximum score being 52, where a higher score signifies a worse outcome
Measured: 24 weeks
To evaluate the changes in MDS-UPDRS II motor symptoms in PD patients with tremor.
- Evaluation of changes in MDS-UPDRS II motor experiences of daily living (MEDL) score
- Evaluation of changes in Movement Disorders Society- United Parkinson's Disease Rating Scale Part II motor experiences of daily living (MEDL) score with a minimum score of 0 and a maximum score of 52 with a higher score signifying a worse outcome.
Measured: 24 weeks
To evaluate the changes in cognition, mood and behavior in Parkinson's disease patients treated with Istradefylline.
- Evaluation of changes in EQ5D
- 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 EuroQol 5 Dimension 5 Level (EQ5D), with a minimum score of 1 and a maximum score of 15, with a higher value being associated with a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start20 Jan 2023
- Primary completion23 Feb 2024
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Kirin, Inc.
- Responsible party
- Sponsor
- Investigators
- Fernando Pagan, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885360
- Sponsor's protocol ID
- STUDY00005472
- Status last verified
- Oct 2023
- First submitted
- 7 Feb 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Istradefylline Effect on Parkinson's Disease Tremor, Motor Symptoms and Non-motor Symptoms
- ClinicalTrials.gov ID
- NCT05885360
- Acronym / sponsor ID
- STUDY00005472
- Conditions
- Parkinson Disease, Tremor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Kyowa Kirin, Inc.
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Istradefylline 20 and 40 mg | Experimental | Drug: Istradefylline PillThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- · Written informed consent
Key exclusion criteria (11 listed)
- · 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Istradefylline PillAlso: NOURIANZIstradefylline 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. | Drug | Istradefylline 20 and 40 mg |
Primary outcome
To observe the effect of Istradefylline on tremor in PD patients.
Time frame: 8 weeks
· 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.
7 secondary outcomes
To evaluate the changes in MDS-UPDRS part I (non-motor) in PD patients with tremor.
Time frame: 24 weeks
To evaluate the changes in MDS-UPDRS II motor symptoms in PD patients with tremor.
Time frame: 24 weeks
To evaluate the changes in cognition, mood and behavior in Parkinson's disease patients treated with Istradefylline.
Time frame: 24 weeks
To evaluate the the Geriatric depression scale (GDS) in PD patients with tremor.
Time frame: 24 weeks
To evaluate the effect of Istradefylline on activities of daily living in PD patients with tremor.
Time frame: 24 weeks
To assess the utility of a tremor capturing application such as Mindsquare app.
Time frame: 24 weeks
To assess changes in motor impairment using the Right Eye eye- tracking technology.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Pagan principal investigator
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Istradefylline Pill in people with Parkinson Disease and Tremor, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the effect of Istradefylline on tremor in PD patients. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.