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

Sponsor
Adamas Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02471222
Collaborator
(none)
60
Enrollment
15
Locations
2
Arms
13
Duration (Months)
4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher plasma amantadine concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to deliver its primary treatment effect during the day, and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ADS-5102 (amantadine HCl extended release)

Drug: ADS-5102
Oral capsules to be administered once daily at bedtime for 4 weeks
Other Names:
  • amantadine HCl extended release

    		•
    Placebo Comparator: Placebo

    Other: Placebo
    Oral capsules to be administered once daily at bedtime for 4 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test [Up to 4 weeks]

    Secondary Outcome Measures

    1. Timed 25 Foot Walk [Up to 4 weeks]

    2. Timed Up and go [Up to 4 weeks]

    3. 2 Minute Walk Test [Up to 4 weeks]

    4. MS Walking Scale-12 [Up to 4 weeks]

    Other Outcome Measures

    1. Fatigue Scale for Motor and Cognitive Functions [Up to 4 weeks]

    2. Beck's Depression Inventory-2 [Up to 4 weeks]

    3. Brief International Cognitive Assessment for MS [Up to 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed a current IRB-approved informed consent form;

    • Male or female subjects between 18 and 70 years of age, inclusive;

    • Confirmed diagnosis of Multiple Sclerosis according to the 2010 Revised McDonald criteria;

    • On a stable regimen of medications taken specifically to treat MS for at least 30 days prior to screening, and willing to continue the same doses and regimens for the duration of study participation;

    • Stable physical activity level for at least 30 days prior to screening and willing to continue without change for the duration of study participation;

    • Maximum EDSS score during screening of 6.5;

    • Sufficient ambulatory ability to complete two trials of the Timed 25 Foot Walk (T25FW) at the screening visit;

    • A score on each completed screening T25FW test between 8 and 45 seconds, inclusive;

    • Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation;

    • If taking an antidepressant, must be on a stable dose for at least 60 days prior to screening.

    Exclusion Criteria:

    • History of seizures within 2 years prior to screening;

    • Clinically significant MS relapse with onset less than 30 days prior to screening;

    • Presence of vertigo or other vestibular dysfunction that might compromise ability to safely perform the T25FW;

    • Received physical therapy within 30 days prior to screening;

    • Received systemic steroids within 30 days prior to screening;

    • Received dalfampridine, methylphenidate, modafinil, armodafinil, amantadine, and/or any product containing amphetamines, or any treatment specifically for fatigue or to improve walking within 30 days prior to screening;

    • Received any botulinum toxin containing product used as antispasmodic agent within 3 months prior to screening;

    • History of clinically significant hallucinations due to an MS medication or other/unknown cause, within 2 years prior to screening;

    • History of Bipolar Disorder or Psychosis, regardless of treatment;

    • Presence of cognitive impairment sufficient, in the opinion of the investigator, to affect the subject's ability to complete study assessments, or which would not be in the subject's best interest to participate in the study;

    • History of stroke or TIA within 2 years prior to screening;

    • History of cancer within 5 years;

    • Presence of untreated angle closure glaucoma;

    • 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 screening through at least 4 weeks after the completion of study treatment;

    • Treatment with an investigational drug or device within 30 days prior to screening;

    • Treatment with an investigational biologic within 6 months prior to screening;

    • Current participation in another clinical trial;

    • Planned elective surgery during study participation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States 85018
    2 Aurora Colorado United States 80045
    3 Sarasota Florida United States 34239
    4 Atlanta Georgia United States 30309
    5 Northbrook Illinois United States 60062
    6 Rochester Minnesota United States 55905
    7 Lincoln Nebraska United States 68506
    8 Albuquerque New Mexico United States 87131
    9 Patchogue New York United States 11772
    10 Raleigh North Carolina United States 27607
    11 Cleveland Ohio United States 44195
    12 Oklahoma City Oklahoma United States 73104
    13 Franklin Tennessee United States 37064
    14 Dallas Texas United States 75214
    15 Kirkland Washington United States 11772

    Sponsors and Collaborators

    • Adamas Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Adamas Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02471222
    Other Study ID Numbers:
    • ADS-AMT-MS201
    First Posted:
    Jun 15, 2015
    Last Update Posted:
    Aug 8, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Amantadine

    Study Results

    No Results Posted as of Aug 8, 2017