Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 85
Updated:1/12/2018
Start Date:October 2014
End Date:March 10, 2016

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ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)

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.


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;
We found this trial at
22
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Morgantown, WV
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Fountain Valley, California 92708
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Greensboro, North Carolina 27401
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Innsbruck,
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West Bloomfield, Michigan 48322
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West Bloomfield, MI
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