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Trial record 1 of 7 for:    ADS-5102 Amantadine
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A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03567057
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date April 20, 2020
Actual Study Start Date  ICMJE July 18, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
Incidence of adverse events (safety and tolerability) of ADS-5102 in subjects with MS [ Time Frame: Through study completion, an average of 1 year. ]
The primary outcome measure will be a tabulation of the treatment emergent adverse events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • Timed 25-Foot Walk [ Time Frame: As a change from baseline at weeks 4, 12, 24 and 52 ]
    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 time to complete (seconds) or speed (feet per second). Improvement is indicated by a decrease in time or an increase in speed.
  • Timed up and go [ Time Frame: As a change from baseline at weeks 4, 12, 24 and 52 ]
    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.
  • 2-Minute Walk Test [ Time Frame: As a change from baseline at weeks 4, 12, 24 and 52 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Official Title  ICMJE A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
Brief Summary This is a multicenter, open-label extension (OLE) study of ADS-5102 (amantadine extended release [ER] capsules) in subjects with MS and walking impairment who completed a prior study of ADS-5102 in subjects with MS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Walking Impairment
Intervention  ICMJE Drug: ADS-5102
Oral capsules to be administered once daily at bedtime for the 52-week open-label treatment period.
Other Name: amantadine extended release
Study Arms  ICMJE Experimental: ADS-5102
Intervention: Drug: ADS-5102
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2018)
540
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03567057
Other Study ID Numbers  ICMJE ADS-AMT-MS303
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adamas Pharmaceuticals, Inc.
Study Sponsor  ICMJE Adamas Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Chief Medical Officer, MD Adamas Pharmaceuticals, Inc.
PRS Account Adamas Pharmaceuticals, Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP