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Condition (MeSH)

Amyotrophic Lateral Sclerosis

ClinicalTrials.gov lists 969 trials for Amyotrophic Lateral Sclerosis or a narrower condition beneath it. National Institute of Neurological Disorders and Stroke (NINDS) has the most among industry and government lead sponsors, with 11.

MeSH D000690 Nervous System Diseases C10 C18 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 121 Phase 1/2 Phase 1/2 68 Phase 2 Phase 2 167 Phase 2/3 Phase 2/3 39 Phase 3 Phase 3 51 Phase 4 Phase 4 8 Not applicable Not applicable 230 Observational Observational 272 Phase 1 Phase 1 121 Phase 1/2 Phase 1/2 68 Phase 2 Phase 2 167 Phase 2/3 Phase 2/3 39 Phase 3 Phase 3 51 Phase 4 Phase 4 8 Not applicable Not applicable 230 Observational Observational 272

Trials per phase (log scale)

1 more section with rows

969 of the 969 trials are tagged with Amyotrophic Lateral Sclerosis itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Amyotrophic Lateral Sclerosis trials start? (31)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 3 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 80

1991: 1 trials (Observational 1) 1992: 1 trials (Phase 2 1) 1996: 3 trials (Observational 3) 1998: 1 trials (Observational 1) 2000: 1 trials (Observational 1) 2001: 5 trials (Observational 2, Phase 4 1, Phase 3 1, Phase 2 1) 2002: 6 trials (Observational 3, Phase 2/3 1, Phase 2 2) 2003: 5 trials (Phase 3 3, Phase 2/3 1, Phase 2 1) 2004: 6 trials (Observational 3, Not applicable 2, Phase 2 1) 2005: 13 trials (Observational 3, Not applicable 1, Phase 3 1, Phase 2/3 1, Phase 2 5, Phase 1/2 2) 2006: 19 trials (Observational 8, Phase 3 4, Phase 2 6, Phase 1/2 1) 2007: 21 trials (Observational 9, Not applicable 1, Phase 4 1, Phase 3 2, Phase 2/3 2, Phase 2 2, Phase 1/2 2, Phase 1 2) 2008: 26 trials (Observational 8, Not applicable 2, Phase 4 1, Phase 2/3 1, Phase 2 8, Phase 1/2 4, Phase 1 2) 2009: 26 trials (Observational 6, Not applicable 5, Phase 3 4, Phase 2/3 2, Phase 2 5, Phase 1/2 2, Phase 1 2) 2010: 15 trials (Observational 1, Not applicable 5, Phase 2/3 1, Phase 2 1, Phase 1/2 2, Phase 1 5) 2011: 23 trials (Observational 5, Not applicable 3, Phase 3 2, Phase 2/3 1, Phase 2 6, Phase 1/2 2, Phase 1 4) 2012: 32 trials (Observational 7, Not applicable 8, Phase 3 3, Phase 2/3 2, Phase 2 7, Phase 1/2 1, Phase 1 4) 2013: 35 trials (Observational 10, Not applicable 7, Phase 4 1, Phase 3 1, Phase 2/3 2, Phase 2 11, Phase 1/2 1, Phase 1 2) 2014: 28 trials (Observational 10, Not applicable 7, Phase 2 4, Phase 1/2 3, Phase 1 4) 2015: 48 trials (Observational 20, Not applicable 12, Phase 3 1, Phase 2 5, Phase 1/2 1, Phase 1 9) 2016: 39 trials (Observational 10, Not applicable 8, Phase 3 2, Phase 2 7, Phase 1/2 5, Phase 1 7) 2017: 52 trials (Observational 14, Not applicable 17, Phase 3 2, Phase 2/3 2, Phase 2 9, Phase 1/2 2, Phase 1 6) 2018: 41 trials (Observational 11, Not applicable 10, Phase 3 2, Phase 2 9, Phase 1/2 5, Phase 1 4) 2019: 50 trials (Observational 14, Not applicable 11, Phase 3 4, Phase 2/3 2, Phase 2 10, Phase 1/2 2, Phase 1 7) 2020: 52 trials (Observational 14, Not applicable 10, Phase 3 2, Phase 2/3 9, Phase 2 11, Phase 1/2 3, Phase 1 3) 2021: 72 trials (Observational 21, Not applicable 16, Phase 4 1, Phase 3 8, Phase 2 16, Phase 1/2 2, Phase 1 8) 2022: 47 trials (Observational 12, Not applicable 16, Phase 3 3, Phase 2/3 1, Phase 2 5, Phase 1/2 4, Phase 1 6) 2023: 54 trials (Observational 18, Not applicable 17, Phase 4 1, Phase 3 2, Phase 2/3 2, Phase 2 4, Phase 1/2 1, Phase 1 9) 2024: 72 trials (Observational 20, Not applicable 23, Phase 4 1, Phase 3 1, Phase 2/3 1, Phase 2 7, Phase 1/2 7, Phase 1 12) 2025: 80 trials (Observational 17, Not applicable 27, Phase 4 1, Phase 3 1, Phase 2/3 5, Phase 2 12, Phase 1/2 3, Phase 1 14)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 74
2025 80
2024 72
2023 54
2022 47
2021 72
2020 52
2019 50
2018 41
2017 52

Showing 10 of 31 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 90 trials starting in 2026 and about 83 in 2027, the average of the 24 months through September, counted as registered and carried forward, with about 0.7 times the starts already registered for the rest of 2026 added. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 15 percent and ran about 1 percent high against the count later registered; forecasts made before the year began were off by about 26 percent and ran about 20 percent low against the count later registered. The part-way figures are from forecasts that used a multiple fitted only on earlier years. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 124 trials still running at the 2026-10-09 snapshot; registered median of 25 months across 505 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Amyotrophic Lateral Sclerosis trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 121
Phase 1/2 68
Phase 2 167
Phase 2/3 39
Phase 3 51
Phase 4 8
Not applicable 230
Observational 272
Expanded access 13

How many Amyotrophic Lateral Sclerosis trials are recruiting? (13)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 56
Recruiting 176
Enrolling by invitation 14
Active, not recruiting 47
Available 3

Showing 5 of 13 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Amyotrophic Lateral Sclerosis trials? (5)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
National Institute of Neurological Disorders and Stroke (NINDS) 11
Biogen 9
Cytokinetics 9
Knopp Biosciences 9
Amylyx Pharmaceuticals Inc. 8

Which drugs are being tested for Amyotrophic Lateral Sclerosis? (7)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Riluzole 25
Dexpramipexole 9
Edaravone 7
CK-2017357 6
Arimoclomol 5

Showing 5 of 7 drugs.

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Interventions as named in the registry (8)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
AMX0035 7
Lumbar puncture 6
MRI 6
CNM-Au8 5
nL-CHCHD-001 4

Showing 5 of 8 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Amyotrophic Lateral Sclerosis trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Respiratory failure 370 42
Dysphagia 239 33
Pneumonia 214 44
RESPIRATORY FAILURE 207 4
DYSPHAGIA 151 3

Showing 5 of 10 adverse events.

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Which publications cover Amyotrophic Lateral Sclerosis? (970)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Clinical safety of ultra-high-dose methylcobalamin in patients with amyotrophic lateral sclerosis: Open-label extension of a phase 2/3 randomized controlled study. Journal of the neurological sciences 2026 Yes
Safety and efficacy of the Atalante exoskeleton in the rehabilitation of French patients with amyotrophic lateral sclerosis: a prospective, monocentric, open, uncontrolled, interventional protocol, EXALS. BMJ open 2026 Yes
Verdiperstat in Amyotrophic Lateral Sclerosis: Results From the Randomized HEALEY ALS Platform Trial. JAMA neurology 2025 Yes
Quantifying multimodal longitudinal brain changes in presymptomatic C9orf72 disease. Alzheimer's & dementia : the journal of the Alzheimer's Association 2025 Yes
Plasma neurofilament analysis in VITALITY-ALS. Amyotrophic lateral sclerosis & frontotemporal degeneration 2025 Yes

Showing 5 of 970 publications.

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Prevalence (99)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Amyotrophic lateral sclerosis Point prevalence 1-9 / 100 000 United Kingdom GB Unspecified
Amyotrophic lateral sclerosis Annual incidence 1-9 / 100 000 United Kingdom GB Exact
Amyotrophic lateral sclerosis Annual incidence 1-9 / 100 000 United Kingdom GB Unspecified
Amyotrophic lateral sclerosis Point prevalence 1-9 / 100 000 United Kingdom GB Exact
Amyotrophic lateral sclerosis Point prevalence 1-9 / 100 000 United Kingdom GB Exact

Showing 5 of 99 prevalence observations.

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Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Amyotrophic lateral sclerosis 803 Exact Orphanet Rare Disease Ontology (ORDO)
Amyotrophic lateral sclerosis 803 Exact Orphadata Science knowledge files, Product 1

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: sub-conditions in mesh.

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