Parkinson's Disease (PD) Clinical Trial
Official title:
Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)
This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).
Participation in this study was offered to subjects who were described by one of the
following 3 groups:
- Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and
chose to immediately transition into the current study without a time gap; this group
was subdivided into Group 1A, consisting of subjects who received ADS-5102 in the
previous Adamas efficacy study, and Group 1P, consisting of subjects who received
placebo in the previous Adamas efficacy study
- Group 2: Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in
LID and entered the current study with a time gap
- Group 3: Subjects who would have been deemed ineligible for participation in a previous
Adamas efficacy study due to having undergone DBS
Consented subjects who completed Screening (Visit 1) and met study eligibility criteria were
to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of
ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2
capsules) daily at bedtime; this dose was to continue through Week 100. During the final week
(Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at
bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to
return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug
dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their
dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1
capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during
the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to
complete the 1 week of reduced dosing.
Efficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning
with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up
Visit was to occur approximately 2 weeks following the completion of treatment. AEs were
recorded beginning with the first dose of study drug and continued through the Safety
Follow-up Visit. Concomitant medications were recorded throughout the study.
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