Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia

NCT ID: NCT02274766

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-10

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 (PD)

Study Design

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

Study Groups

ADS-5102 (amantadine HCl extended release)

ADS-5102 (amantadine HCl extended release)

Group Type: EXPERIMENTAL

ADS-5102

Intervention Type: DRUG

Oral capsules to be administered once nightly at bedtime, for 13 weeks.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Oral capsules to be administered once nightly at bedtime, for 13 weeks.

Interventions

ADS-5102

Oral capsules to be administered once nightly at bedtime, for 13 weeks.

Intervention Type: DRUG

Placebo

Oral capsules to be administered once nightly at bedtime, for 13 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 (trained 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 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, in situ cervical cancer, or other definitively treated cancer that is considered cured;
• 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, using one of the following: barrier methods (diaphragm or partner using condoms plus use of spermicidal jelly or foam, preferably double-barrier methods); oral or implanted hormonal contraceptive; intrauterine device (IUD); or vasectomized male partner;
• 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

Fountain Valley, California, United States

Sunnyvale, California, United States

Boca Raton, Florida, United States

Jacksonville, Florida, United States

Port Charlotte, Florida, United States

Sunrise, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Kansas City, Kansas, United States

Baltimore, Maryland, United States

Elkridge, Maryland, United States

Boston, Massachusetts, United States

West Bloomfield, Michigan, United States

Greensboro, North Carolina, United States

Raleigh, North Carolina, United States

Tulsa, Oklahoma, United States

Roanoke, Virginia, United States

Kirkland, Washington, United States

Morgantown, West Virginia, United States

Milwaukee, Wisconsin, United States

Innsbruck, , Austria

Vienna, , Austria

Vienna, , Austria

Bordeaux, , France

Bron, , France

Clermont-Ferrand, , France

Lille, , France

Marseille, , France

Montpellier, , France

Poitier, , France

Rennes, , France

Rouen, , France

Strasbourg, , France

Toulouse, , France

München, Bavaria, Germany

München, Bavaria, Germany

Beelitz-Heilstätten, Brandenburg, Germany

Göttingen, Lower Saxony, Germany

Leipzig, Saxony, Germany

Gera, Thuringia, Germany

Stadtroda, Thuringia, Germany

Berlin, , Germany

Berlin, , Germany

Hamburg, , Germany

Kassel, , Germany

Marburg, , Germany

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Countries

United States; Austria; France; Germany; Spain

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)

Other Identifiers

ADS-AMT-PD304

Identifier Type: -

Identifier Source: org_study_id