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 |
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).
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
55
sites
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