Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
Condition: Dyskinesia; Levodopa-Induced Dyskinesia (LID); Parkinson's Disease (PD)
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: ADS-5102; Placebo
Intervention description: Oral capsules to be administered once nightly at bedtime, for 13 weeks.; Oral capsules to be administered once nightly at bedtime, for 13 weeks.
Intervention MeSH terms: Amantadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
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 multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group
      study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an
      investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of
      levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel
      pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the
      early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in
      the evening, potentially reducing the negative impact of amantadine on sleep. This
      pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER
      formulation than can be tolerated with an immediate-release formulation. The once-nightly
      dosing regimen may also provide enhanced convenience and compliance.

      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly
      reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed a current IRB/REB/IEC-approved informed consent form;

          -  Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical
             Diagnostic Criteria;

          -  On a stable regimen of antiparkinson's medications for at least 30 days prior to
             screening, including a levodopa preparation administered not less than three times
             daily, and willing to continue the same doses and regimens during study participation;

          -  Following diary training, the subject is willing and able to understand and complete
             the 24-hour PD home diary (trained caregiver/study partner assistance allowed);

          -  Any other current and allowed prescription/non-prescription medications and/or
             nutritional supplements taken regularly must have been at a stable dose and regimen
             for at least 30 days prior to screening, and subject must be willing to continue the
             same doses and regimens during study participation (this criterion does not apply to
             medications that are being taken pre-study only on an as-needed basis);

        Exclusion Criteria:

          -  History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain
             stimulation);

          -  History of seizures within 2 years prior to screening;

          -  History of stroke or TIA within 2 years prior to screening;

          -  History of cancer within 5 years prior to screening, with the following exceptions:
             adequately treated non-melanomatous skin cancers, localized bladder cancer,
             non-metastatic prostate cancer, in situ cervical cancer, or other definitively treated
             cancer that is considered cured;

          -  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, using
             one of the following: barrier methods (diaphragm or partner using condoms plus use of
             spermicidal jelly or foam, preferably double-barrier methods); oral or implanted
             hormonal contraceptive; intrauterine device (IUD); or vasectomized male partner;

          -  Treatment with an investigational drug or device within 30 days prior to screening;

          -  Treatment with an investigational biologic within 6 months prior to screening;

          -  Current participation in another clinical trial;