A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567057
• Other study ID #: ADS-AMT-MS303
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2018
• Est. completion date: April 18, 2021

Study information

• Verified date: January 2022
• Source: Adamas Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: April 18, 2021
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Walking Impairment

Intervention

Drug:
• ADS-5102, 274 mg
Oral capsules

Locations

Country	Name	City	State
Canada	Adamas Clinical Site	Burnaby	Brithis Columbia
Canada	Adamas Clinical Site	Edmonton	Alberta
Canada	Adamas Clinical Site	Greenfield Park	Quebec
Canada	Adamas Clinical Site	Hamilton	Ontario
Canada	Adamas Clinical Site	Lethbridge	Alberta
Canada	Adamas Clinical Site	London	Ontario
Canada	Adamas Clinical Site	Montréal	Quebec
Canada	Adamas Clinical Site	Ottawa	Ontario
Canada	Adamas Clinical Site	Québec City	Quebec
Canada	Adamas Clinical Site	Vancouver	British Columbia
United States	Adamas Clinical Site	Albuquerque	New Mexico
United States	Adamas Clinical Site	Amherst	New York
United States	Adamas Clinical Site	Atlanta	Georgia
United States	Adamas Clinical Site	Aurora	Colorado
United States	Adamas Clinical Site	Burlington	Massachusetts
United States	Adamas Clinical Site	Carlsbad	California
United States	Adamas Clinical Site	Centerville	Ohio
United States	Adamas Clinical Site	Charleston	South Carolina
United States	Adamas Clinical Site	Charlotte	North Carolina
United States	Adamas Clinical Site	Cleveland	Ohio
United States	Adamas Clinical Site	Colorado Springs	Colorado
United States	Adamas Clinical Site	Columbus	Ohio
United States	Adamas Clinical Site	Cordova	Tennessee
United States	Adamas Clinical Site	Cullman	Alabama
United States	Adamas Clinical Site	Denver	Colorado
United States	Adamas Clinical Site	Detroit	Michigan
United States	Adamas Clinical Site	Fairfield	Connecticut
United States	Adamas Clinical Site	Farmington Hills	Michigan
United States	Adamas Clinical Site	Fort Collins	Colorado
United States	Adamas Clinical Site	Foxboro	Massachusetts
United States	Adamas Clinical Site	Franklin	Tennessee
United States	Adamas Clinical Site	Fresno	California
United States	Adamas Clinical Site	Fullerton	California
United States	Adamas Clinical Site	Golden Valley	Minnesota
United States	Adamas Clinical Site	Great Falls	Montana
United States	Adamas Clinical Site	Greer	South Carolina
United States	Adamas Clinical Site	Houston	Texas
United States	Adamas Clinical Site	Houston	Texas
United States	Adamas Clinical Site	Indianapolis	Indiana
United States	Adamas Clinical Site	Johnson City	Tennessee
United States	Adamas Clinical Site	Kansas City	Kansas
United States	Adamas Clinical Site	Kansas City	Missouri
United States	Adamas Clinical Site	Kirkland	Washington
United States	Adamas Clinical Site	Lake Success	New York
United States	Adamas Clinical Site	Las Vegas	Nevada
United States	Adamas Clinical Site	Lenexa	Kansas
United States	Adamas Clinical Site	Lincoln	Nebraska
United States	Adamas Clinical Site	Long Beach	California
United States	Adamas Clinical Site	Lubbock	Texas
United States	Adamas Clinical Site	Maitland	Florida
United States	Adamas Clinical Site	Miami	Florida
United States	Adamas Clinical Site	Miami	Florida
United States	Adamas Clinical Site	Milwaukee	Wisconsin
United States	Adamas Clinical Site	Naples	Florida
United States	Adamas Clinical Site	New London	Connecticut
United States	Adamas Clinical Site	New York	New York
United States	Adamas Clinical Site	Newport Beach	California
United States	Adamas Clinical Site	Newport News	Virginia
United States	Adamas Clinical Site	Norfolk	Virginia
United States	Adamas Clinical Site	Northbrook	Illinois
United States	Adamas Clinical Site	Oklahoma City	Oklahoma
United States	Adamas Clinical Site	Omaha	Nebraska
United States	Adamas Clinical Site	Orlando	Florida
United States	Adamas Clinical Site	Ormond Beach	Florida
United States	Adamas Clinical Site	Overland Park	Kansas
United States	Adamas Clinical Site	Palm Coast	Florida
United States	Adamas Clinical Site	Patchogue	New York
United States	Adamas Clinical Site	Philadelphia	Pennsylvania
United States	Adamas Clinical Site	Phoenix	Arizona
United States	Adamas Clinical Site	Phoenix	Arizona
United States	Adamas Clinical Site	Plainview	New York
United States	Adamas Clinical Site	Port Charlotte	Florida
United States	Adamas Clinical Site	Portland	Oregon
United States	Adamas Clinical Site	Raleigh	North Carolina
United States	Adamas Clinical Site	Rochester	New York
United States	Adamas Clinical Site	Rock Hill	South Carolina
United States	Adamas Clinical Site	Round Rock	Texas
United States	Adamas Clinical Site	Sacramento	California
United States	Adamas Clinical Site	Saint Louis	Missouri
United States	Adamas Clinical Site	Saint Petersburg	Florida
United States	Adamas Clinical Site	Salt Lake City	Utah
United States	Adamas Clinical Site	Sarasota	Florida
United States	Adamas Clinical Site	Savannah	Georgia
United States	Adamas Clinical Site	Seattle	Washington
United States	Adamas Clinical Site	Seattle	Washington
United States	Adamas Clinical Site	Spartanburg	South Carolina
United States	Adamas Clinical Site	Staten Island	New York
United States	Adamas Clinical Site	Tampa	Florida
United States	Adamas Clinical Site	Tucson	Arizona
United States	Adamas Clinical Site	Vero Beach	Florida
United States	Adamas Clinical Site	Washington	District of Columbia
United States	Adamas Clinical Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Adamas Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Events	The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.	Through study completion, an average of 1 year.
Secondary	Timed 25-Foot Walk (Feet/Second) (Baseline Value)	The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.	Baseline
Secondary	Timed 25-Foot Walk (Feet/Second) (Week 24 Value)	The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.	24 weeks
Secondary	Timed 25-Foot Walk (Feet/Second) (Week 52 Value)	The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.	52 weeks
Secondary	Timed up and go (Baseline Value)	The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.	Baseline
Secondary	Timed up and go (Week 24 Value)	The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.	24 weeks
Secondary	Timed up and go (Week 52 Value)	The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.	52 weeks
Secondary	2-Minute Walk Test (Baseline Value)	The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.	Baseline
Secondary	2-Minute Walk Test (Week 24 Value)	The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.	24 weeks
Secondary	2-Minute Walk Test (Week 52 Value)	The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.	52 weeks