Phase 3
Completed N=424
A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Multiple Sclerosis · Walking Impairment
Source: ClinicalTrials.gov NCT03567057 ↗
Enrolled (actual)
424
Serious AEs
11.1%
Results posted
Jan 2022
Primary outcomePrimary: Number of Patients With Adverse Events — 122; 116; 86 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events |
122; 116; 86 | — |
| SECONDARY Timed 25-Foot Walk (Feet/Second) (Baseline Value) |
2.43; 2.68; 2.66 | — |
| SECONDARY Timed 25-Foot Walk (Feet/Second) (Week 24 Value) |
2.50; 2.72; 2.71 | — |
| SECONDARY Timed 25-Foot Walk (Feet/Second) (Week 52 Value) |
2.35; 2.68; 2.65 | — |
| SECONDARY Timed up and go (Baseline Value) |
17.60; 16.89; 16.80 | — |
| SECONDARY Timed up and go (Week 24 Value) |
17.39; 15.36; 16.89 | — |
| SECONDARY Timed up and go (Week 52 Value) |
18.68; 15.92; 17.37 | — |
| SECONDARY 2-Minute Walk Test (Baseline Value) |
80.26; 89.99; 87.31 | — |
| SECONDARY 2-Minute Walk Test (Week 24 Value) |
81.48; 87.99; 92.03 | — |
| SECONDARY 2-Minute Walk Test (Week 52 Value) |
77.45; 89.18; 89.14 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03567057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.