NCT02202551

Open-Label Safety Study of ADS-5102 in PD Patients With LID

Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Adamas Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Dyskinesia
• Levodopa Induced Dyskinesia (LID)
• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	ADS-5102

Timeline

• Start date: 2014-07-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2014-07-29
• Last updated: 2020-10-06
• Results posted: 2020-09-16

Locations

87 sites across 6 countries: United States, Austria, Canada, France, Germany, Spain