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.
Minimum age: 30 Years.
Maximum age: 85 Years.
Gender(s): Both.
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 (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 transient ischemic attack (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 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 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
Birmingham, Alabama 35233, United States
Edmonton, Alberta T6G 2B7, Canada
Phoenix, Arizona 85013, United States
Scottsdale, Arizona 85259, United States
Sun City, Arizona 85351, United States
Fountain Valley, California 92708, United States
Pasadena, California 91105, United States
Reseda, California 91335, United States
Sacramento, California 95817, United States
Torrance, California 90505, United States
Ventura, California 93003, United States
Aurora, Colorado 80045, United States
Manchester, Connecticut 06040, United States
Boca Raton, Florida 33486, United States
Gainesville, Florida 32607, United States
Naples, Florida 34102, United States
Port Charlotte, Florida 33980, United States
Sunrise, Florida 33351, United States
Tampa, Florida 33613, United States
Weston, Florida 33331, United States
Atlanta, Georgia 30329, United States
Chicago, Illinois 60612, United States
Des Moines, Iowa 50309, United States
Kansas City, Kansas 66160, United States
Bingham Farms, Michigan 48025, United States
West Bloomfield, Michigan 48322, United States
Golden Valley, Minnesota 55427, United States
St. Louis, Missouri 63110, United States
Albany, New York 12208, United States
Commack, New York 11725, United States
New York, New York 10003, United States
New York, New York 10016, United States
New York, New York 10029, United States
Raleigh, North Carolina 27607, United States
Cincinnati, Ohio 45219, United States
Cleveland, Ohio 44195, United States
Toledo, Ohio 43614, United States
Tulsa, Oklahoma 74136, United States
Toronto, Ontario M5T 2S8, Canada
Philadelphia, Pennsylvania 19107, United States
Regina, Saskatchewan S4T 1A5, Canada
Dallas, Texas 75390, United States
Houston, Texas 77030-1, United States
Houston, Texas 77030-2, United States
Kirkland, Washington 98034, United States
Milwaukee, Wisconsin 53233, United States