Clinical trial NCT02202551: Open-Label Safety Study of ADS-5102 in PD Patients With LID
Official title: Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyskinesia
Levodopa Induced Dyskinesia (LID)
Parkinson's Disease (PD)
Keywords: Levodopa Induced Dyskinesia
LID
Parkinsonism
Parkinson's Disease
Lead sponsor: Adamas Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 223
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: Participation in this study was offered to subjects who were described by one of the following 3 groups:

* Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and chose to immediately transition into the current study without a time gap; this group was subdivided into Group 1A, consisting of subjects who received ADS-5102 in the previous Adamas efficacy study, and Group 1P, consisting of subjects who received placebo in the previous Adamas efficacy study
* Group 2: Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in LID and entered the current study with a time gap
* Group 3: Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS

Consented subjects who completed Screening (Visit 1) and met study eligibility criteria were to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2 capsules) daily at bedtime; this dose was to continue through Week 100. During the final week (Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1 capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to complete the 1 week of reduced dosing.

Efficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up Visit was to occur approximately 2 weeks following the completion of treatment. AEs were recorded beginning with the first dose of study drug and continued through the Safety Follow-up Visit. Concomitant medications were recorded throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations
timeFrame: Up to 101 weeks
Secondary outcomes:
measure: Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)
timeFrame: 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).
measure: Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)
timeFrame: 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).
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Reseda
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Torrance
country: United States
state: California
city: Ventura
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Manchester
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Elkridge
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Bingham Farms
country: United States
state: Michigan
city: West Bloomfield
country: United States
state: Michigan
city: Golden Valley
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Commack
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Roanoke
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Innsbruck
country: Austria
city: Vienna
country: Austria
city: Vienna
country: Austria
city: Edmonton
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Regina
country: Canada
state: Saskatchewan
city: Bordeaux
country: France
city: Bron
country: France
city: Clermont Ferrand
country: France
city: Lille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Poitiers
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Beelitz-Heilstätten
country: Germany
state: Brandenburg
city: Göttingen
country: Germany
state: Niedersachsen
city: Leipzig
country: Germany
state: Sachsen
city: Gera
country: Germany
state: Thüringen
city: Stadtroda
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Kassel
country: Germany
city: Marburg
country: Germany
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
Study officials:
affiliation: Adamas Pharmaceuticals, Inc.
name: Clinical Trials Director
role: STUDY_DIRECTOR
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