Status:
TERMINATED
Effect of Istradefylline Treatment on Behavioral Measures of Apathy in Parkinson's Disease.
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Kyowa Kirin, Inc.
Conditions:
Apathy
Parkinson Disease
Eligibility:
All Genders
18-99 years
Brief Summary
Apathy is defined as a lack of feeling, emotion, interest, or concern. Apathy also involves reduction or loss of motivation and goal-directed behavior. Clinically significant apathy, where meaningful ...
Detailed Description
Apathy is a clinical syndrome characterized by lack of motivation, interest, engagement, and emotional reactivity for goal-directed behaviors (Starkstein et al., 2008). A common and troublesome sympto...
Eligibility Criteria
Inclusion
- Diagnosis of PD consistent with United Kingdom Brain Bank Criteria or the Movement Disorder Society Research Criteria for the Diagnosis of Parkinson's Disease, with bradykinesia and sequence effect being present, and prominent motor asymmetry (if no rest tremor).
- Current treatment with levodopa.
- Stable on levodopa and other study-approved medications for PD motor symptoms for at least four weeks prior to screening.
- Clinically significant wearing-off / fluctuating symptomatology warranting treatment with ISD
- Presence of apathy at baseline (LARS \> -22)
- Living with adult informant
Exclusion
- Current or prior treatment with istradefylline. 2. History of Deep Brain Stimulation (DBS) surgery, ablative surgery (e.g., pallidotomy, thalamotomy, focused ultrasound, etc.), Duopa pump implantation, or other invasive intervention for Parkinson's disease symptoms. 3. Injury or concomitant health condition at screening that would preclude engagement in light physical activity. 10 4. Prior history of cerebrovascular accident (e.g., stroke or aneurysm) or seizure disorder (other than febrile seizures during childhood). 5. Dementia (MoCA\<22) 6. Psychotic symptoms that would raise concern for safe use of ISD, 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 × severity) or B (frequency × severity) scales of the NPI. 7. Depressive mood symptoms at baseline likely to interfere with response to treatment (BDI-II\>19) 8. Active suicidal ideation within 1 year prior to Screening Visit as determined by a positive response to Question 4 or 5 on the C-SSRS. 9. Diagnosis or treatment for any central nervous system disorder other than Parkinson's disease that could be expected in the eyes of the investigator to impact ability to participate in study. 10. Contraindications / conditions that would preclude safe dosing of 40mg ISD 11. Change in medications for mood or anxiety within 6 weeks of enrollment or anticipation of change in medications for mood or anxiety during the 8-week study period. 12. Moderate or severe hepatic impairment. 13. Current treatment with strong CYP3A4 inhibitors 14. Current treatment with strong CYP3A4 inducers 15. Pregnant women are not able to participate due to unknown safety risks associated with ISD
Key Trial Info
Start Date :
July 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05182151
Start Date
July 29 2022
End Date
December 1 2023
Last Update
January 30 2024
Active Locations (1)
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1
MUSC Movement Disorders Program
Charleston, South Carolina, United States, 29425