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

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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.

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
Walking Impairment Multiple Sclerosis Drug: ADS-5102 Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
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 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: amantadine HCl extended release
Placebo Comparator: Placebo Other: Placebo
Oral capsules to be administered once daily at bedtime for 4 weeks



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Timed 25 Foot Walk [ Time Frame: Up to 4 weeks ]
  2. Timed Up and go [ Time Frame: Up to 4 weeks ]
  3. 2 Minute Walk Test [ Time Frame: Up to 4 weeks ]
  4. MS Walking Scale-12 [ Time Frame: Up to 4 weeks ]

Other Outcome Measures:
  1. Fatigue Scale for Motor and Cognitive Functions [ Time Frame: Up to 4 weeks ]
  2. Beck's Depression Inventory-2 [ Time Frame: Up to 4 weeks ]
  3. Brief International Cognitive Assessment for MS [ Time Frame: Up to 4 weeks ]


Information from the National Library of Medicine

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

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.

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): NCT02471222


Locations
United States, Arizona
Phoenix, Arizona, United States, 85018
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Sarasota, Florida, United States, 34239
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Illinois
Northbrook, Illinois, United States, 60062
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Nebraska
Lincoln, Nebraska, United States, 68506
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Patchogue, New York, United States, 11772
United States, North Carolina
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Franklin, Tennessee, United States, 37064
United States, Texas
Dallas, Texas, United States, 75214
United States, Washington
Kirkland, Washington, United States, 11772
Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.

Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02471222     History of Changes
Other Study ID Numbers: ADS-AMT-MS201
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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
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