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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 : Completed
First Posted : June 25, 2018
Results First Posted : January 18, 2022
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Walking Impairment Drug: ADS-5102, 274 mg Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: N/A
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
Actual Primary Completion Date : November 17, 2020
Actual Study Completion Date : April 18, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ADS-5102, 274 mg
274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks
 Drug: ADS-5102, 274 mg
Oral capsules
Other Name: amantadine extended release


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Adverse Events [ Time Frame: Through study completion, an average of 1 year. ]
    The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.


Secondary Outcome Measures :
  1. Timed 25-Foot Walk (Feet/Second) (Baseline Value) [ Time Frame: Baseline ]
    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.

  2. Timed 25-Foot Walk (Feet/Second) (Week 24 Value) [ Time Frame: 24 weeks ]
    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.

  3. Timed 25-Foot Walk (Feet/Second) (Week 52 Value) [ Time Frame: 52 weeks ]
    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.

  4. Timed up and go (Baseline Value) [ Time Frame: Baseline ]
    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.

  5. Timed up and go (Week 24 Value) [ Time Frame: 24 weeks ]
    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.

  6. Timed up and go (Week 52 Value) [ Time Frame: 52 weeks ]
    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.

  7. 2-Minute Walk Test (Baseline Value) [ Time Frame: Baseline ]
    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.

  8. 2-Minute Walk Test (Week 24 Value) [ Time Frame: 24 weeks ]
    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.

  9. 2-Minute Walk Test (Week 52 Value) [ Time Frame: 52 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
Investigators
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Study Director: Clinical Trials Chief Medical Officer, MD Adamas Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Adamas Pharmaceuticals, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] April 19, 2018

More Information
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Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03567057    
Other Study ID Numbers: ADS-AMT-MS303
First Posted: June 25, 2018    Key Record Dates
Results First Posted: January 18, 2022
Last Update Posted: January 18, 2022
Last Verified: January 2022

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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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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Amantadine
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