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NCT Number: NCT03567057

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

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Walking Impairment

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Adamas Clinical Site, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADS-5102, 274 mg

Drug

Oral capsules

Other names: amantadine extended release

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Adamas Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 25, 2018
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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