Phase 3
Completed N=223
Open-Label Safety Study of ADS-5102 in PD Patients With LID
Dyskinesia · Levodopa Induced Dyskinesia (LID) · Parkinson's Disease (PD)
Source: ClinicalTrials.gov NCT02202551 ↗
Enrolled (actual)
223
Serious AEs
26.9%
Results posted
Sep 2020
Primary outcomePrimary: Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations — 57; 70; 23; 55 Participants
◆ Published Evidence
Established
52citations · ~6 / year
ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study.
Summary
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).
Linked Publications
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ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations |
57; 70; 23; 55; 31; 45 | — |
| SECONDARY Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) |
41.8; 45.6; 52.8; 52.4; 1.2; -2.8 | — |
| SECONDARY Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) |
6.5; 9.6; 9.8; 10.4; -0.2; -3.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02202551) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.