Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy 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: NCT02471222
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE June 11, 2015
First Posted Date  ICMJE June 15, 2015
Last Update Posted Date August 8, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test [ Time Frame: Up to 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
  • Timed 25 Foot Walk [ Time Frame: Up to 4 weeks ]
  • Timed Up and go [ Time Frame: Up to 4 weeks ]
  • 2 Minute Walk Test [ Time Frame: Up to 4 weeks ]
  • MS Walking Scale-12 [ Time Frame: Up to 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 12, 2015)
  • Fatigue Scale for Motor and Cognitive Functions [ Time Frame: Up to 4 weeks ]
  • Beck's Depression Inventory-2 [ Time Frame: Up to 4 weeks ]
  • Brief International Cognitive Assessment for MS [ Time Frame: Up to 4 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Official Title  ICMJE Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Walking Impairment
  • Multiple Sclerosis
Intervention  ICMJE
  • Drug: ADS-5102
    Oral capsules to be administered once daily at bedtime for 4 weeks
    Other Name: amantadine HCl extended release
  • Other: Placebo
    Oral capsules to be administered once daily at bedtime for 4 weeks
Study Arms  ICMJE
  • Experimental: ADS-5102 (amantadine HCl extended release)
    Intervention: Drug: ADS-5102
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02471222
Other Study ID Numbers  ICMJE ADS-AMT-MS201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adamas Pharmaceuticals, Inc.
Study Sponsor  ICMJE Adamas Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adamas Pharmaceuticals, Inc.
Verification Date August 2017

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