Abstract Details

Title Interim Analysis of Istradefylline Effects on Tremor in Parkinson's Disease Patients—Promising Benefits on Tremor Control

Topic Movement Disorders

Presentation(s) P4 - Poster Session 4 (11:45 AM-12:45 PM)

Poster/Presentation
Number 3-006

Objective

To evaluate the effect of istradefylline on motor symptoms in tremor-dominant Parkinson’s disease.

Background Istradefylline is an adenosine A2A antagonist used to address “OFF” episodes in PD. Patients report improvement in tremor when treated with istradefylline, but no studies have been conducted thus far on this subject.

Design/Methods

In this 6-month open-label, single-arm, pilot study, 27 patients with PD were treated with 40 mg daily istradefylline (after titrating up from 20 mg for two weeks) as add-on therapy for motor symptom management. Selected patients have levodopa-resistant tremor-dominant PD. Patient motor and non-motor symptoms were evaluated through MDS-UPDRS part I-IV at baseline and 24 weeks. Additional MDS-UPDRS Part III assessments were completed at weeks four and eight.

Ten patients have completed the study so far. Total MDS-UPDRS part III and tremor scale scores (Parts 3.15-3.18) were analyzed for each visit. Differences were calculated between baseline, 8 weeks, and 24 weeks.

Results

The sums of the tremor scale scores within MDS-UPDRS part III were compared at 8 and 24 weeks vs. baseline for the 10 patients who have completed the study. There was an observed mean reduction of 7.4 points between 8w and baseline and 7.6 points between 24w and baseline (p < 10^-6 for both time points, two-tailed permutation test).

MDS-UPDRS Part III total decreased by an average of 25.6 points between 8w and baseline (decreased in 9/10 patients, p = 0.002148), and 23.7 between 24w and baseline (decreased in 10/10 patients, p = 0.001953). Analysis of MDS-UPDRS Part III total data used two-tailed sign tests.

Conclusions

Istradefylline was effective in decreasing both the tremor subcomponent and total MDS-UPDRS Part III score for patients who have completed the study. Additional findings are incoming as the remaining patients complete the study, including tremor amplitude scores utilizing a state-of-the art tremor mobile app.

Authors/Disclosures
Irma Zhang PRESENTER	Ms. Zhang has nothing to disclose.
Michelle Umali (Georgetown)	No disclosure on file
Gonul Ozay, MD	Dr. Ozay has nothing to disclose.
Luke D. Lovelace (Georgetown University)	No disclosure on file
Michael Barry (Illinois Institute of Technology)	No disclosure on file
Lina Ariza Serrano, MD (Medstar Health)	Dr. Ariza Serrano has nothing to disclose.
Alexandre Mason Sharma, MD	Dr. Mason Sharma has nothing to disclose.
Lana Raslan	No disclosure on file
Yasar A. Torres-Yaghi, MD	Dr. Torres-Yaghi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Torres-Yaghi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Torres-Yaghi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Torres-Yaghi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbott. Dr. Torres-Yaghi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Torres-Yaghi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Torres-Yaghi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion .
Fernando L. Pagan, MD, FAAN (Georgetown University Hospital Dept of Neurology)	Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Adamas. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for US World Meds. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Adamas. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurocrine. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Clinical Parkinsonism and related Disorders. Dr. Pagan has stock in Keiferx. The institution of Dr. Pagan has received research support from US World Meds. The institution of Dr. Pagan has received research support from Novartis.

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