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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02202551
• Date of registration: 25/07/2014
• Prospective Registration: No
• Primary sponsor: Adamas Pharmaceuticals, Inc.
• Public title: Open-Label Safety Study of ADS-5102 in PD Patients With LID
• Scientific title: Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)
• Date of first enrolment: July 2014
• Target sample size: 223
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02202551
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Canada, France, Germany, Spain, United States

Contacts

• Name: Clinical Trials Director
• Affiliation: Adamas Pharmaceuticals, Inc.

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dyskinesia

Parkinson's Disease (PD)

Levodopa Induced Dyskinesia (LID)

Intervention(s)

Drug: ADS-5102

Primary Outcome(s)

Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations [Time Frame: Up to 101 weeks]

Secondary Outcome(s)

Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) [Time Frame: 100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).]

Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) [Time Frame: Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).]

Secondary ID(s)

ADS-AMT-PD302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02202551