ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)

NCT02136914 | Completed Phase 3 Results

• 1 other identifier: ADS-AMT-PD301
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 46

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

Conditions

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

Keywords

Levodopa Induced Dyskinesia; LID; Parkinsonism

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12

  The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.

  Baseline to Week 12

Secondary Outcomes (4)

• Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24

  Baseline to Week 24

• Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)

  Baseline (BL) to Week 12 (W12) and Week 24 (W24)

• Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)

  Baseline (BL) to Week 12 (W12) and Week 24 (W24)

• Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms

  Baseline to Week 12 and Week 24

Study Arms (2)

ADS-5102

EXPERIMENTAL

ADS-5102 (amantadine HCl extended release)

Drug: ADS-5102

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

ADS-5102 DRUG

Oral capsules to be administered once nightly at bedtime, for 25 weeks

Also known as: amantadine HCl extended release

ADS-5102

Placebo OTHER

Oral capsules to be administered once nightly at bedtime, for 25 weeks

Placebo

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
• Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
• On a stable regimen of antiparkinson's medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
• Following diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (caregiver/study partner assistance allowed)
• Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis)

You may not qualify if:

• History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
• History of seizures within 2 years prior to screening
• History of stroke or transient ischemic attack (TIA) within 2 years prior to screening
• History of cancer within 5 years prior to screening, 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 or device within 30 days prior to screening
• Treatment with an investigational biologic within 6 months prior to screening
• Current participation in another clinical trial

Sponsors & Collaborators

• Adamas Pharmaceuticals, Inc.: lead

Study Sites (46)

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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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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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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, 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, 60612, United States

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Des Moines, Iowa, 50309, United States

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Kansas City, Kansas, 66160, 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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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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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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Kirkland, Washington, 98034, United States

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Milwaukee, Wisconsin, 53233, United States

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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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Related Publications (4)

• Hauser RA, Mehta SH, Kremens D, Chernick D, Formella AE. Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia. Neurol Ther. 2021 Dec;10(2):739-751. doi: 10.1007/s40120-021-00256-1. Epub 2021 May 22.

  PMID: 34024025 DERIVED

• Mehta SH, Pahwa R, Tanner CM, Hauser RA, Johnson R. Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia. Neurol Ther. 2021 Jun;10(1):307-320. doi: 10.1007/s40120-021-00246-3. Epub 2021 Apr 17.

  PMID: 33864229 DERIVED

• Elmer LW, Juncos JL, Singer C, Truong DD, Criswell SR, Parashos S, Felt L, Johnson R, Patni R. Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson's Disease. CNS Drugs. 2018 Apr;32(4):387-398. doi: 10.1007/s40263-018-0498-4.

  PMID: 29532440 DERIVED

• Pahwa R, Tanner CM, Hauser RA, Isaacson SH, Nausieda PA, Truong DD, Agarwal P, Hull KL, Lyons KE, Johnson R, Stempien MJ. ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson Disease (EASE LID Study): A Randomized Clinical Trial. JAMA Neurol. 2017 Aug 1;74(8):941-949. doi: 10.1001/jamaneurol.2017.0943.

  PMID: 28604926 DERIVED

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: Head, Regulatory Affairs
• Organization: Adamas Pharmaceuticals, Inc.

drugsafety@adamaspharma.com

+1 (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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 13, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 6, 2018
• Results First Posted: February 6, 2018

Record last verified: 2018-01

Locations

US (43); CA (3)