Evidence map›Paper›PMID 34449295›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2022

A Phase 3, double-blind, placebo-controlled efficacy and safety study of ADS-5102 (Amantadine) extended-release capsules in people with multiple sclerosis and walking impairment.

Jeffrey A Cohen, Michelle H Cameron, Myla D Goldman, Andrew D Goodman, Aaron E Miller, Anne Rollins, Lily Llorens, Rajiv Patni, Robert Elfont, Reed Johnson

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Modulating glutamate neurotransmission inFrontiers in immunology · 2026
    Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

Jeffrey A CohenMellen Center for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9245-9772
Michelle H CameronVeterans Affairs Portland Health Care System/Oregon Health & Science University, Portland, OR, USA.
Myla D GoldmanVirginia Commonwealth University, Richmond, VA, USA.ORCID 0000-0002-5675-945X
Andrew D GoodmanUniversity of Rochester Medical Center, Rochester, NY, USA.
Aaron E MillerThe Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Anne RollinsAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Lily LlorensAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Rajiv PatniAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Robert ElfontAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Reed JohnsonAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Adamas Pharmaceuticals (United States) · USCleveland Clinic · USIcahn School of Medicine at Mount Sinai · USOregon Health & Science University · USUniversity of Rochester Medical Center · USVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundADS-5102, a delayed-release, extended-release (DR/ER) amantadine, improved walking speed in MS in a Phase 2 trial.

objectiveThe aim of this study was to present primary results of a Phase 3, double-blind, ADS-5102 trial (INROADS) for walking speed.

methodsAdult participants with MS and walking impairment, not currently using amantadine or dalfampridine, underwent 4-week placebo run-in before randomization 1:1:1 to placebo, 137 or 274 mg/day ADS-5102 for 12 weeks. Primary outcome was the proportion of responders (20% increase in Timed 25-Foot Walk (T25FW) speed) for 274 mg ADS-5102 versus placebo at end of double-blind (Study Week 16). Additional measures included Timed Up and Go (TUG), 2-Minute Walk Test (2MWT), and 12-item Multiple Sclerosis Walking Scale (MSWS-12).

resultsIn total, 558 participants were randomized and received double-blind treatment. Significantly more participants responded with 274 mg ADS-5102 (21.1%) versus placebo (11.3%). Mean T25FW speed also significantly improved (0.19 ft/s) versus placebo (0.07 ft/s). Other measures were not significant using prespecified hierarchical testing procedure. Adverse events led to discontinuation for 3.8% (placebo), 6.4% (137 mg ADS-5102), and 20.5% (274 mg ADS-5102).

conclusionINROADS met its primary endpoint, showing a significantly greater proportion of participants with meaningful improvement in walking speed for 274 mg ADS-5102 versus placebo. Numeric dose response was seen for some secondary efficacy outcomes and adverse events.

Indexed as

Multiple Sclerosis4-AminopyridineAdultAmantadineDelayed-Action PreparationsDouble-Blind MethodHumansWalking4-AminopyridineAmantadineDelayed-Action Preparations2-Minute Walk TestamantadineMultiple sclerosisMultiple Sclerosis Walking Scale-12randomized controlled trialTimed 25-Foot WalkTimed Up and Go

Identifiers

PMID34449295
PMCPMC8978468
OpenAlexW3193616556

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.