Clinical trial NCT03567057: A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Official title: A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Walking Impairment
Lead sponsor: Adamas Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).

Detailed description: This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301.

All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period.

Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54.

All study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible.

Eligibility criteria: Inclusion Criteria:

* Signed a current IRB-approved informed consent form
* Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.

Exclusion Criteria:

* Based on the judgment of the investigator or Medical Monitor, participation in the study would jeopardize the safety of the subject.
* 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 a highly effective hormonal method of contraception (an IUD, or vasectomized male partner is also acceptable), in combination with a barrier method, from baseline through at least 4 weeks after the completion of study treatment. If a sexually active male, does not agree to utilize condoms from screening through at least 4 weeks after the completion of study treatment.
* Anticipated treatment with any amantadine formulation other than ADS-5102
* Planned participation in another interventional clinical trial

Primary outcomes:
measure: Number of Patients With Adverse Events
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Timed 25-Foot Walk (Feet/Second) (Baseline Value)
timeFrame: Baseline
measure: Timed 25-Foot Walk (Feet/Second) (Week 24 Value)
timeFrame: 24 weeks
measure: Timed 25-Foot Walk (Feet/Second) (Week 52 Value)
timeFrame: 52 weeks
measure: Timed up and go (Baseline Value)
timeFrame: Baseline
measure: Timed up and go (Week 24 Value)
timeFrame: 24 weeks
measure: Timed up and go (Week 52 Value)
timeFrame: 52 weeks
measure: 2-Minute Walk Test (Baseline Value)
timeFrame: Baseline
measure: 2-Minute Walk Test (Week 24 Value)
timeFrame: 24 weeks
measure: 2-Minute Walk Test (Week 52 Value)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Adamas Clinical Site
state: Alabama
city: Phoenix
country: United States
facility: Adamas Clinical Site
state: Arizona
city: Phoenix
country: United States
facility: Adamas Clinical Site
state: Arizona
city: Tucson
country: United States
facility: Adamas Clinical Site
state: Arizona
city: Carlsbad
country: United States
facility: Adamas Clinical Site
state: California
city: Fresno
country: United States
facility: Adamas Clinical Site
state: California
city: Fullerton
country: United States
facility: Adamas Clinical Site
state: California
city: Long Beach
country: United States
facility: Adamas Clinical Site
state: California
city: Newport Beach
country: United States
facility: Adamas Clinical Site
state: California
city: Sacramento
country: United States
facility: Adamas Clinical Site
state: California
city: Aurora
country: United States
facility: Adamas Clinical Site
state: Colorado
city: Colorado Springs
country: United States
facility: Adamas Clinical Site
state: Colorado
city: Denver
country: United States
facility: Adamas Clinical Site
state: Colorado
city: Fort Collins
country: United States
facility: Adamas Clinical Site
state: Colorado
city: Fairfield
country: United States
facility: Adamas Clinical Site
state: Connecticut
city: New London
country: United States
facility: Adamas Clinical Site
state: Connecticut
city: Washington
country: United States
facility: Adamas Clinical Site
state: District of Columbia
city: Maitland
country: United States
facility: Adamas Clinical Site
state: Florida
city: Miami
country: United States
facility: Adamas Clinical Site
state: Florida
city: Miami
country: United States
facility: Adamas Clinical Site
state: Florida
city: Naples
country: United States
facility: Adamas Clinical Site
state: Florida
city: Orlando
country: United States
facility: Adamas Clinical Site
state: Florida
city: Ormond Beach
country: United States
facility: Adamas Clinical Site
state: Florida
city: Palm Coast
country: United States
facility: Adamas Clinical Site
state: Florida
city: Port Charlotte
country: United States
facility: Adamas Clinical Site
state: Florida
city: Saint Petersburg
country: United States
facility: Adamas Clinical Site
state: Florida
city: Sarasota
country: United States
facility: Adamas Clinical Site
state: Florida
city: Tampa
country: United States
facility: Adamas Clinical Site
state: Florida
city: Vero Beach
country: United States
facility: Adamas Clinical Site
state: Florida
city: Atlanta
country: United States
facility: Adamas Clinical Site
state: Georgia
city: Savannah
country: United States
facility: Adamas Clinical Site
state: Georgia
city: Northbrook
country: United States
facility: Adamas Clinical Site
state: Illinois
city: Indianapolis
country: United States
facility: Adamas Clinical Site
state: Indiana
city: Kansas City
country: United States
facility: Adamas Clinical Site
state: Kansas
city: Lenexa
country: United States
facility: Adamas Clinical Site
state: Kansas
city: Overland Park
country: United States
facility: Adamas Clinical Site
state: Kansas
city: Burlington
country: United States
facility: Adamas Clinical Site
state: Massachusetts
city: Foxboro
country: United States
facility: Adamas Clinical Site
state: Massachusetts
city: Worcester
country: United States
facility: Adamas Clinical Site
state: Massachusetts
city: Detroit
country: United States
facility: Adamas Clinical Site
state: Michigan
city: Farmington Hills
country: United States
facility: Adamas Clinical Site
state: Michigan
city: Golden Valley
country: United States
facility: Adamas Clinical Site
state: Minnesota
city: Kansas City
country: United States
facility: Adamas Clinical Site
state: Missouri
city: Saint Louis
country: United States
facility: Adamas Clinical Site
state: Missouri
city: Great Falls
country: United States
facility: Adamas Clinical Site
state: Montana
city: Lincoln
country: United States
facility: Adamas Clinical Site
state: Nebraska
city: Omaha
country: United States
facility: Adamas Clinical Site
state: Nebraska
city: Las Vegas
country: United States
facility: Adamas Clinical Site
state: Nevada
city: Albuquerque
country: United States
facility: Adamas Clinical Site
state: New Mexico
city: Amherst
country: United States
facility: Adamas Clinical Site
state: New York
city: Lake Success
country: United States
facility: Adamas Clinical Site
state: New York
city: New York
country: United States
facility: Adamas Clinical Site
state: New York
city: Patchogue
country: United States
facility: Adamas Clinical Site
state: New York
city: Plainview
country: United States
facility: Adamas Clinical Site
state: New York
city: Rochester
country: United States
facility: Adamas Clinical Site
state: New York
city: Staten Island
country: United States
facility: Adamas Clinical Site
state: New York
city: Charlotte
country: United States
facility: Adamas Clinical Site
state: North Carolina
city: Raleigh
country: United States
facility: Adamas Clinical Site
state: North Carolina
city: Centerville
country: United States
facility: Adamas Clinical Site
state: Ohio
city: Cleveland
country: United States
facility: Adamas Clinical Site
state: Ohio
city: Columbus
country: United States
facility: Adamas Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Adamas Clinical Site
state: Oklahoma
city: Portland
country: United States
facility: Adamas Clinical Site
state: Oregon
city: Philadelphia
country: United States
facility: Adamas Clinical Site
state: Pennsylvania
city: Charleston
country: United States
facility: Adamas Clinical Site
state: South Carolina
city: Greer
country: United States
facility: Adamas Clinical Site
state: South Carolina
city: Rock Hill
country: United States
facility: Adamas Clinical Site
state: South Carolina
city: Spartanburg
country: United States
facility: Adamas Clinical Site
state: South Carolina
city: Cordova
country: United States
facility: Adamas Clinical Site
state: Tennessee
city: Franklin
country: United States
facility: Adamas Clinical Site
state: Tennessee
city: Johnson City
country: United States
facility: Adamas Clinical Site
state: Tennessee
city: Houston
country: United States
facility: Adamas Clinical Site
state: Texas
city: Houston
country: United States
facility: Adamas Clinical Site
state: Texas
city: Lubbock
country: United States
facility: Adamas Clinical Site
state: Texas
city: Round Rock
country: United States
facility: Adamas Clinical Site
state: Texas
city: Salt Lake City
country: United States
facility: Adamas Clinical Site
state: Utah
city: Newport News
country: United States
facility: Adamas Clinical Site
state: Virginia
city: Norfolk
country: United States
facility: Adamas Clinical Site
state: Virginia
city: Kirkland
country: United States
facility: Adamas Clinical Site
state: Washington
city: Seattle
country: United States
facility: Adamas Clinical Site
state: Washington
city: Seattle
country: United States
facility: Adamas Clinical Site
state: Washington
city: Milwaukee
country: United States
facility: Adamas Clinical Site
state: Wisconsin
city: Edmonton
country: Canada
facility: Adamas Clinical Site
state: Alberta
city: Lethbridge
country: Canada
facility: Adamas Clinical Site
state: Alberta
city: Burnaby
country: Canada
facility: Adamas Clinical Site
state: Brithis Columbia
city: Vancouver
country: Canada
facility: Adamas Clinical Site
state: British Columbia
city: Hamilton
country: Canada
facility: Adamas Clinical Site
state: Ontario
city: London
country: Canada
facility: Adamas Clinical Site
state: Ontario
city: Ottawa
country: Canada
facility: Adamas Clinical Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Adamas Clinical Site
state: Quebec
city: Montréal
country: Canada
facility: Adamas Clinical Site
state: Quebec
city: Québec City
country: Canada
facility: Adamas Clinical Site
state: Quebec
Study officials:
affiliation: Adamas Pharmaceuticals, Inc.
name: Clinical Trials Chief Medical Officer, MD
role: STUDY_DIRECTOR
References: