Clinical trial NCT02471222: Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Official title: Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Walking Impairment
Multiple Sclerosis
Lead sponsor: Adamas Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Timed 25 Foot Walk
timeFrame: Up to 4 weeks
measure: Timed Up and go
timeFrame: Up to 4 weeks
measure: 2 Minute Walk Test
timeFrame: Up to 4 weeks
measure: MS Walking Scale-12
timeFrame: Up to 4 weeks
Other outcomes:
measure: Fatigue Scale for Motor and Cognitive Functions
timeFrame: Up to 4 weeks
measure: Beck's Depression Inventory-2
timeFrame: Up to 4 weeks
measure: Brief International Cognitive Assessment for MS
timeFrame: Up to 4 weeks
Locations:
city: Phoenix
country: United States
state: Arizona
city: Aurora
country: United States
state: Colorado
city: Sarasota
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Northbrook
country: United States
state: Illinois
city: Rochester
country: United States
state: Minnesota
city: Lincoln
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Patchogue
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Franklin
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Kirkland
country: United States
state: Washington
Study officials:
References: