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

Information source: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyskinesia; Levodopa Induced Dyskinesia (LID); Parkinson's Disease

Intervention: ADS-5102 (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Adamas Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Clinical Trials Director, Study Director, Affiliation: Adamas Pharmaceuticals, Inc.

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.

Clinical Details

Official title: Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in the Unified Dyskinesia Rating Scale (UDysRS) score

Secondary outcome:

Change in the standardized PD home diary (ON time without dyskinesia, ON time with troublesome dyskinesia, OFF time)

Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Clinician's Global Impression of Change in overall PD symptoms

Change in the Unified Dyskinesia Rating Scale (UDysRS) Score

Eligibility

Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Birmingham, Alabama 35233, United States

Edmonton, Alberta T6G 2B7, Canada

Phoenix, Arizona 85013, United States

Scottsdale, Arizona 85259, United States

Sun City, Arizona 85351, United States

Fountain Valley, California 92708, United States

Pasadena, California 91105, United States

Reseda, California 91335, United States

Sacramento, California 95817, United States

Torrance, California 90505, United States

Ventura, California 93003, United States

Aurora, Colorado 80045, United States

Manchester, Connecticut 06040, United States

Boca Raton, Florida 33486, United States

Gainesville, Florida 32607, United States

Naples, Florida 34102, United States

Port Charlotte, Florida 33980, United States

Sunrise, Florida 33351, United States

Tampa, Florida 33613, United States

Weston, Florida 33331, United States

Atlanta, Georgia 30329, United States

Chicago, Illinois 60612, United States

Des Moines, Iowa 50309, United States

Kansas City, Kansas 66160, United States

Bingham Farms, Michigan 48025, United States

West Bloomfield, Michigan 48322, United States

Golden Valley, Minnesota 55427, United States

St. Louis, Missouri 63110, United States

Albany, New York 12208, United States

Commack, New York 11725, United States

New York, New York 10003, United States

New York, New York 10016, United States

New York, New York 10029, United States

Raleigh, North Carolina 27607, United States

Cincinnati, Ohio 45219, United States

Cleveland, Ohio 44195, United States

Toledo, Ohio 43614, United States

Tulsa, Oklahoma 74136, United States

Toronto, Ontario M5T 2S8, Canada

Philadelphia, Pennsylvania 19107, United States

Regina, Saskatchewan S4T 1A5, Canada

Dallas, Texas 75390, United States

Houston, Texas 77030-1, United States

Houston, Texas 77030-2, United States

Kirkland, Washington 98034, United States

Milwaukee, Wisconsin 53233, United States

Additional Information

Starting date: May 2014
Last updated: July 10, 2015

Page last updated: August 23, 2015

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