Scottsdale, Arizona 85259

  • Parkinson's Disease (PD)

Purpose:

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).


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


Study is Available At:


Original ID:

ADS-AMT-PD302


NCT ID:

NCT02202551


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

30 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Adamas Pharmaceuticals, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

250


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Clinical Trials Director
Study Director
Adamas Pharmaceuticals, Inc.

Study Dates

Start Date:July 2014
Completion Date:March 2018
Completion Type:Anticipated
Primary Completion Date:March 2018
Primary Completion Type:Anticipated
Verification Date:October 2017
Last Changed Date:October 6, 2017
First Received Date:July 25, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety and tolerability of ADS-5102 assessed by adverse events, safety-related study drug discontinuation, vital signs, and safety laboratory tests
Time Frame:Up to 105 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame:Up to 105 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ADS-5102
Arm Name:ADS-5102
Other Name:amantadine HCl extended release

Study Arms

Study Arm Type:Experimental
Arm Name:ADS-5102
Description:amantadine HCl extended release

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Adamas Pharmaceuticals, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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