Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
1 other identifier
interventional
60
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 8, 2017
August 1, 2017
1.1 years
June 11, 2015
August 1, 2017
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (4)
Timed 25 Foot Walk
Up to 4 weeks
Timed Up and go
Up to 4 weeks
2 Minute Walk Test
Up to 4 weeks
MS Walking Scale-12
Up to 4 weeks
Other Outcomes (3)
Fatigue Scale for Motor and Cognitive Functions
Up to 4 weeks
Beck's Depression Inventory-2
Up to 4 weeks
Brief International Cognitive Assessment for MS
Up to 4 weeks
Study Arms (2)
ADS-5102 (amantadine HCl extended release)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Phoenix, Arizona, 85018, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Sarasota, Florida, 34239, United States
Unknown Facility
Atlanta, Georgia, 30309, United States
Unknown Facility
Northbrook, Illinois, 60062, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
Lincoln, Nebraska, 68506, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
Patchogue, New York, 11772, United States
Unknown Facility
Raleigh, North Carolina, 27607, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Franklin, Tennessee, 37064, United States
Unknown Facility
Dallas, Texas, 75214, United States
Unknown Facility
Kirkland, Washington, 11772, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 15, 2015
Study Start
May 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 8, 2017
Record last verified: 2017-08