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

Phase 3

Completed

Conditions: Multiple Sclerosis
Walking Impairment

Interventions: Drug: ADS-5102, 274 mg

Registration Number: NCT03567057

Lead Sponsor: Adamas Pharmaceuticals, Inc.

Brief Summary: This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).

Detailed Description: This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301.

All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period.

Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54.

All study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 424

Inclusion Criteria

Signed a current IRB-approved informed consent form
Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.

Exclusion Criteria

Based on the judgment of the investigator or Medical Monitor, participation in the study would jeopardize the safety of the subject.
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 baseline through at least 4 weeks after the completion of study treatment. If a sexually active male, does not agree to utilize condoms from screening through at least 4 weeks after the completion of study treatment.
Anticipated treatment with any amantadine formulation other than ADS-5102
Planned participation in another interventional clinical trial

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADS-5102, 274 mg	ADS-5102, 274 mg	274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events	Through study completion, an average of 1 year.	The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.

Secondary Outcome Measures

Name	Time	Method
Timed up and go (Week 24 Value)	24 weeks	The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
Timed 25-Foot Walk (Feet/Second) (Week 52 Value)	52 weeks	The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Timed up and go (Baseline Value)	Baseline	The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
Timed 25-Foot Walk (Feet/Second) (Week 24 Value)	24 weeks	The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Timed up and go (Week 52 Value)	52 weeks	The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
2-Minute Walk Test (Baseline Value)	Baseline	The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
2-Minute Walk Test (Week 52 Value)	52 weeks	The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
Timed 25-Foot Walk (Feet/Second) (Baseline Value)	Baseline	The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
2-Minute Walk Test (Week 24 Value)	24 weeks	The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.