Open-Label Safety Study of ADS-5102 in PD Patients With LID
Condition: Dyskinesia; Levodopa Induced Dyskinesia (LID); Parkinson's Disease (PD)
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): ADS-5102
Intervention type(s): Drug
Other intervention name(s): amantadine HCl extended release
Intervention MeSH terms: Amantadine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levodopa Induced Dyskinesia; LID; Parkinsonism; Parkinson's Disease