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

NCT ID: NCT02136914

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ADS-5102

ADS-5102 (amantadine HCl extended release)

Group Type: EXPERIMENTAL

ADS-5102

Intervention Type: DRUG

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

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

ADS-5102

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

amantadine HCl extended release

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adamas Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials Director

Role: STUDY_DIRECTOR

Adamas Pharmaceuticals, Inc.

Locations

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Sun City, Arizona, United States

Fountain Valley, California, United States

Pasadena, California, United States

Reseda, California, United States

Sacramento, California, United States

Torrance, California, United States

Ventura, California, United States

Aurora, Colorado, United States

Manchester, Connecticut, United States

Boca Raton, Florida, United States

Gainesville, Florida, United States

Naples, Florida, United States

Port Charlotte, Florida, United States

Sunrise, Florida, United States

Tampa, Florida, United States

Weston, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Des Moines, Iowa, United States

Kansas City, Kansas, United States

Bingham Farms, Michigan, United States

West Bloomfield, Michigan, United States

Golden Valley, Minnesota, United States

St Louis, Missouri, United States

Albany, New York, United States

Commack, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Toledo, Ohio, United States

Tulsa, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Dallas, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

Kirkland, Washington, United States

Milwaukee, Wisconsin, United States

Edmonton, Alberta, Canada

Toronto, Ontario, Canada

Regina, Saskatchewan, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 34024025 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33864229 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29532440 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28604926 (View on PubMed)

Other Identifiers

ADS-AMT-PD301

Identifier Type: -

Identifier Source: org_study_id