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

NCT02202551 | Completed Phase 3 Results

• 1 other identifier: ADS-AMT-PD302
• Study Type: interventional
• Target: 223
• Locations: 6 countries
• Sites: 87

Brief 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).

Conditions

Dyskinesia; Levodopa Induced Dyskinesia (LID); Parkinson's Disease (PD)

Keywords

Levodopa Induced Dyskinesia; LID; Parkinsonism; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations

  The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).

  Up to 101 weeks

Secondary Outcomes (2)

• Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)

  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).

• Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)

  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).

Study Arms (1)

ADS-5102

EXPERIMENTAL

amantadine HCl extended release

Drug: ADS-5102

Interventions

ADS-5102 DRUG

Also known as: amantadine HCl extended release

ADS-5102

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adamas Pharmaceuticals, Inc.: lead

Study Sites (87)

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Birmingham, Alabama, 35233, United States

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Phoenix, Arizona, 85013, United States

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Scottsdale, Arizona, 85259, United States

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Sun City, Arizona, 85351, United States

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Fountain Valley, California, 92708, United States

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Pasadena, California, 91105, United States

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Reseda, California, 91335, United States

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Sacramento, California, 95817, United States

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Sunnyvale, California, 94085, United States

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Torrance, California, 90505, United States

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Ventura, California, 93003, United States

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Aurora, Colorado, 80045, United States

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Manchester, Connecticut, 06040, United States

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Boca Raton, Florida, 33486, United States

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Gainesville, Florida, 32607, United States

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Jacksonville, Florida, 32209, United States

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Naples, Florida, 34102, United States

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Port Charlotte, Florida, 33980, United States

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Sunrise, Florida, 33351, United States

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Tampa, Florida, 33612, United States

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Tampa, Florida, 33613, United States

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Weston, Florida, 33331, United States

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Atlanta, Georgia, 30329, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Des Moines, Iowa, 45219, United States

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Kansas City, Kansas, 66160, United States

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Baltimore, Maryland, 21287, United States

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Elkridge, Maryland, 21075, United States

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Boston, Massachusetts, 02114, United States

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Bingham Farms, Michigan, 48025, United States

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West Bloomfield, Michigan, 48322, United States

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Golden Valley, Minnesota, 55427, United States

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St Louis, Missouri, 63110, United States

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Albany, New York, 12208, United States

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Commack, New York, 11725, United States

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New York, New York, 10003, United States

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New York, New York, 10016, United States

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New York, New York, 10029, United States

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Greensboro, North Carolina, 27405, United States

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Raleigh, North Carolina, 27607, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44195, United States

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Toledo, Ohio, 43614, United States

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Tulsa, Oklahoma, 74136, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19107, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030-1, United States

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Houston, Texas, 77030-2, United States

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Roanoke, Virginia, 24018, United States

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Kirkland, Washington, 98034, United States

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Morgantown, West Virginia, 26506, United States

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Milwaukee, Wisconsin, 53233, United States

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Innsbruck, 6020, Austria

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Vienna, 1080, Austria

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Vienna, 1220, Austria

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Edmonton, Alberta, T6G 2B7, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Regina, Saskatchewan, S4T 1A5, Canada

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Bordeaux, 33076, France

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Bron, 69677, France

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Clermont-Ferrand, 63003, France

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Lille, 59037, France

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Marseille, 13385, France

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Montpellier, 34295, France

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Poitiers, 86021, France

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Rennes, 35033, France

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Rouen, 76031, France

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Strasbourg, 67098, France

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Toulouse, 31059, France

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München, Bavaria, 80804, Germany

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München, Bavaria, 81675, Germany

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Beelitz-Heilstätten, Brandenburg, 14547, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Leipzig, Saxony, 04103, Germany

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Gera, Thuringia, 07751, Germany

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Stadtroda, Thuringia, 07646, Germany

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Berlin, 12163, Germany

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Berlin, 13353, Germany

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Hamburg, 22291, Germany

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Kassel, 34128, Germany

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Marburg, 35043, Germany

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Barcelona, 08028, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Barcelona, 08041, Spain

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MeSH Terms

Conditions

Dyskinesias; Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Reed Johnson
• Organization: Adamas Pharmaceuticals, Inc.

rjohnson@adamaspharma.com

510-450-3500

Study Officials

• Clinical Trials Director

  Adamas Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 6, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Locations

CA (3); US (54); ES (4); DE (12); AU (3); FR (11)