A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Amantadine
Results by group
Number of Patients With Adverse Events
Through study completion, an average of 1 year.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo/274 mg ADS-5102 | 122 Participants | 159 | |
| 137 mg ADS-5102/274 mg ADS-5102 | 116 Participants | 151 | |
| 274 mg ADS-5102/274 mg ADS-5102 | 86 Participants | 114 |
Placebo/274 mg ADS-5102
137 mg ADS-5102/274 mg ADS-5102
274 mg ADS-5102/274 mg ADS-5102
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo/274 mg ADS-5102 | 159 | 20 (12.6%) | 1 |
| 137 mg ADS-5102/274 mg ADS-5102 | 151 | 20 (13.2%) | 0 |
| 274 mg ADS-5102/274 mg ADS-5102 | 114 | 7 (6.1%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Patients With Adverse Events
Through study completion, an average of 1 year.
Safety
Other measures (9)
Timed 25-Foot Walk (Feet/Second) (Baseline Value)
Baseline
Disability progressionWalking and mobilityTimed 25-Foot Walk (Feet/Second) (Week 24 Value)
24 weeks
Disability progressionWalking and mobilityTimed 25-Foot Walk (Feet/Second) (Week 52 Value)
52 weeks
Disability progressionWalking and mobilityTimed up and go (Baseline Value)
Baseline
Walking and mobilityPhysical functionTimed up and go (Week 24 Value)
24 weeks
Walking and mobilityPhysical functionTimed up and go (Week 52 Value)
52 weeks
Walking and mobilityPhysical function2-Minute Walk Test (Baseline Value)
Baseline
Walking and mobility2-Minute Walk Test (Week 24 Value)
24 weeks
Walking and mobility2-Minute Walk Test (Week 52 Value)
52 weeks
Walking and mobility
Who could take part
MS (type not specified) · 18 to 70
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
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History
Started
Jul 2018
Main results due
Nov 2020
Finished
Apr 2021
Results posted
Jan 2022
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