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
Intervention: ADS-5102
Intervention MeSH terms: Amantadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Levodopa Induced Dyskinesia; LID; Parkinsonism; Parkinson's Disease

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed a current IRB/REB/IEC-approved informed consent form

          -  Completed all study visits in previous Adamas efficacy study or were ineligible for
             participation in previous Adamas studies due to having undergone prior deep brain
             stimulation.

          -  Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical
             Diagnostic Criteria

          -  On a stable regimen of antiparkinson's medications at least 30 days prior to
             screening, including a levodopa preparation administered not less than three times
             daily.

          -  History of peak dose dyskinesia that might benefit from specific dyskinesia treatment
             in the judgment of the subject and clinical investigator

        Exclusion Criteria:

          -  Discontinued ADS-5102 in previous Adamas efficacy study due to intolerable or
             unacceptable AEs considered to be related to ADS-5102

          -  History of neurosurgical intervention related to Parkinson's disease, with the
             exception of deep brain stimulation

          -  History of seizures since completion of participation in previous Adamas studies or
             within 2 years

          -  History of stroke or TIA since completion of participation in previous Adamas studies
             or within 2 years

          -  History of cancer since completion of participation in previous Adamas studies or
             within 2 years, with the following exceptions: adequately treated non-melanomatous
             skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ
             cervical cancer

          -  Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination
             (MMSE) score of less than 24 during screening

          -  If female is pregnant or lactating

          -  If a sexually active female, is not surgically sterile or at least 2 years
             post-menopausal, or does not agree to utilize an effective method of contraception
             from screening through at least 4 weeks after the completion of study treatment.

          -  Treatment with an investigational drug (other than ADS-5102) or device within 30 days
             prior to screening

          -  Treatment with an investigational biologic within 6 months prior to screening

          -  Current or planned participation in another interventional clinical trial