Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02274766 : Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
PhasePhase 3
AgesMin: 30 Years Max: 85 Years
Eligibility
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;
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02274766      |      Link to official Clinicaltrials.gov listing
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