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

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ClinicalTrials.gov Identifier: NCT03567057
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Walking Impairment Drug: ADS-5102 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADS-5102 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567057


Contacts
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Contact: Clinical Trials Administrator 5104503500 clinicaltrials@adamaspharma.com
Contact: Clinical Trials Director Study Director, Adamas Pharmaceuticals, Inc.

Locations
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United States, Colorado
Adamas Clinical Site Recruiting
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Adamas Clinical Site Recruiting
Fairfield, Connecticut, United States, 06824
United States, Georgia
Adamas Clinical Site Recruiting
Atlanta, Georgia, United States, 30309
United States, New York
Adamas Clinical Site Recruiting
Patchogue, New York, United States, 11772
United States, Washington
Adamas Clinical Site Recruiting
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
Investigators
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Study Director: Clinical Trials Chief Medical Officer, MD Adamas Pharmaceuticals, Inc.

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Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03567057     History of Changes
Other Study ID Numbers: ADS-AMT-MS303
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Amantadine
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents