Open-Label Safety Study of ADS-5102 in PD Patients With LID



Status:Active, not recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 85
Updated:10/12/2017
Start Date:July 2014
End Date:March 2018

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Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)

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).


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
We found this trial at
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