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| Name | Class |
|---|---|
| Prilenia | INDUSTRY |
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The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
Regimen D will evaluate the safety and efficacy of a single study drug, pridopidine, in participants with ALS.
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683.
Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.
If a participant is randomized to Regimen D Pridopidine, the participant will complete a screening visit to assess additional Regimen D eligibility criteria. Once Regimen D eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active pridopidine or matching placebo.
Regimen D will enroll by invitation, as participants may not choose to enroll in Regimen D. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen D.
For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pridopidine | Experimental | Pridopidine is administered orally twice daily for 24 weeks. |
|
| Matching Placebo | Placebo Comparator | Matching placebo is administered orally twice daily for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pridopidine | Drug | Administration: Oral Dose: 45mg twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression as Assessed by the ALSFRS-R Total Score | Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function. | Baseline to 24 Weeks |
| Mortality Event Rate | Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The rate of mortality was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times. | Baseline to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bulbar Function in Participants With Bulbar Dysfunction at Baseline | Change in bulbar function over time in participants with bulbar dysfunction at baseline as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) bulbar subdomain. Each question is scored from 4 (normal) to 0 (no ability), with a maximum total score of 12 and a minimum total score of 0 for the bulbar subdomain. Patients with higher scores have more bulbar function. Participants were classified as having bulbar dysfunction at baseline if their score on the ALSFRS-R bulbar domain (Q1-Q3) score was less than 12. |
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Inclusion Criteria:
Exclusion Criteria:
The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
Participants with a confirmed prolonged Fridericia-corrected QT (QTcF) interval (defined as a QTcF interval of >450 ms for men and >470 ms for women).
Participants with clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.
Participants with known history of long QT syndrome or a first degree relative with this condition.
Participants using prohibited medications within the 4 weeks prior to the Regimen Specific Screening Visit, as detailed in section 5.9.
Participants using the following medications at the time of the Regimen Specific Screening Visit:
Participants with a known allergy to any ingredient of the study intervention (pridopidine, silicified microcrystalline cellulose, and magnesium stearate).
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| Name | Affiliation | Role |
|---|---|---|
| Merit Cudkowicz, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healey Center for ALS at Mass General | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41406304 | Derived | Geva M, Goldberg YP, Leitner ML, Cruz-Herranz A, Hand R, Chen K, Gershoni Emek N, Tan AM, Paganoni S, Berry JD, Macklin EA, Shefner JM, Cudkowicz ME, Hayden MR. Pridopidine treatment in ALS: subgroup analyses from the HEALEY ALS Platform trial. Amyotroph Lateral Scler Frontotemporal Degener. 2026 May;27(3-4):432-444. doi: 10.1080/21678421.2025.2597935. Epub 2025 Dec 17. | |
| 40067755 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pridopidine | Pridopidine is administered orally twice daily for 24 weeks. Pridopidine: Administration: Oral Dose: 45mg twice daily |
| FG001 | Matching Placebo | Matching placebo is administered orally twice daily for 24 weeks. Matching Placebo: Administration: Oral Dose: one capsule twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Analysis Population includes only placebo participants from the Regimen D Efficacy Regimen Only (ERO) sample; shared placebo participants from other regimens are not included in the Baseline Analysis Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pridopidine | Pridopidine is administered orally twice daily for 24 weeks. Pridopidine: Administration: Oral Dose: 45mg twice daily |
| BG001 | Matching Placebo | Matching placebo is administered orally twice daily for 24 weeks. Matching Placebo: Administration: Oral Dose: one capsule twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease Progression as Assessed by the ALSFRS-R Total Score | Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function. | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Mean | Standard Deviation | points per month | Baseline to 24 Weeks |
|
Up to 35 weeks after participant signed Master Protocol consent.
The total at risk number for serious adverse events and other adverse events differs from the overall numbers due to a participant excluded from full analysis set for efficacy analyses and baseline characteristics due to a diagnosis other than ALS in one participant and due to participant included in the full analysis set for efficacy analyses and baseline characteristics due to being randomized but who never initiated study drug and thus was not considered as risk for safety outcomes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pridopidine | Pridopidine is administered orally twice daily for 24 weeks. Pridopidine: Administration: Oral Dose: 45mg twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular weakness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Healey Center for ALS Project Management | Healey Center for ALS at Massachusetts General Hospital | 833-425-8257 (HALT ALS) | healeyalsplatform@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2021 | Jun 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2022 | Jun 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| C483720 | pridopidine |
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| Matching Placebo |
| Drug |
Administration: Oral Dose: one capsule twice daily |
|
| Baseline to 24 Weeks |
| Bulbar Function in All Randomized Participants | Change in bulbar function over time in all randomized participants as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) bulbar subdomain. Each question is scored from 4 (normal) to 0 (no ability), with a maximum total score of 12 and a minimum total score of 0 for the bulbar subdomain. Patients with higher scores have more bulbar function. | Baseline to 24 Weeks |
| Respiratory Function | Change in respiratory function over time as measured by Slow Vital Capacity (SVC). | Baseline to 24 Weeks |
| Bulbar Function in Participants With Rapid Pre-baseline Progression | Change in bulbar function over time in participants with rapid pre-baseline progression as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) bulbar subdomain. Each question is scored from 4 (normal) to 0 (no ability), with a maximum total score of 12 and a minimum total score of 0 for the bulbar subdomain. Patients with higher scores have more bulbar function. Participants were classified with rapid pre-baseline progression if their change in ALSFRS-R total score between Master Protocol Screening and Regimen Baseline was greater than or equal or 0.75 points per month. | Baseline to 24 Weeks |
| Time to Bulbar Decline | Time to first decline of 1-point or greater post baseline in the ALSFRS-R bulbar domain score among all participants. Analysis performed using interval-censored survival analysis. Results presented as median interval (upper & lower bounded) time to event. | Baseline to 24 Weeks |
| Muscle Strength | Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD). | Baseline to 24 Weeks |
| Number of Participants That Experienced Death or Death Equivalent | The number of participants who died or met the criterion for a death equivalent from the date of their baseline visit to the end of the Week 24visit window (generally 175 days after baseline). The death equivalent criterion is use of permanent assisted ventilation (PAV) for more than 22 hours per day for more than 7 days in a row. | Baseline to 24 Weeks |
| Derived |
| Writing Committee for the HEALEY ALS Platform Trial; Shefner JM, Oskarsson B, Macklin EA, Chibnik LB, Quintana M, Saville BR, Detry MA, Vestrucci M, Marion J, McGlothlin A, Heiman-Patterson T, Chase M, Pothier L, Harkey BA, Yu H, Sherman AV, Hall M, Kittle G, Berry JD, Babu S, Andrews J, D'Agostino D, Tustison E, Scirocco E, Giacomelli E, Alameda G, Locatelli E, Ho D, Quick A, Ajroud-Driss S, Katz J, Heitzman D, Appel SH, Shroff S, Felice K, Maragakis NJ, Simmons Z, Miller TM, Olney N, Weiss MD, Goutman SA, Fernandes JA, Jawdat O, Owegi MA, Foster LA, Vu T, Ilieva H, Newman DS, Arcila-Londono X, Jackson CE, Ladha S, Caress JB, Swenson A, Peltier A, Lewis RA, Fee D, Elliott M, Bedlack R, Kasarskis EJ, Elman L, Rosenfeld J, Walk D, McIlduff C, Twydell P, Young E, Johnson K, Rezania K, Goyal NA, Cohen JA, Benatar M, Jones V, Shah J, Beydoun SR, Wymer JP, Zilliox L, Nayar S, Pattee GL, Martinez-Thompson J, Leitner ML, Chen K, Goldberg YP, Cohen Y, Geva M, Hayden MR, Paganoni S, Cudkowicz ME; HEALEY ALS Platform Trial Study Group. Pridopidine in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial. JAMA. 2025 Feb 17;333(13):1128-37. doi: 10.1001/jama.2024.26429. Online ahead of print. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| El Escorial Diagnosis | Count of Participants | Participants |
|
| ALS Onset Location | Count of Participants | Participants |
|
| Baseline Edaravone Use Flag | Count of Participants | Participants |
|
| Baseline Riluzole Use Flag | Count of Participants | Participants |
|
| Kings Stage | The King's ALS Clinical Staging System is a 4-level ordinal scale with the first three levels indicating the number (1, 2, or 3) of distinct central nervous system regions (bulbar, upper limb, and lower limb) with neuromuscular dysfunction. Level 4a indicates nutritional failure and level 4b indicates respiratory failure. Higher scores indicate a worse disease state. | Count of Participants | Participants |
|
| ALSFRS-R Total Score | The ALS Functional Rating Score-Revised (ALSFRS-R) measures 12 aspects of physical function. Each of the 12 questions assessing distinct functional ability is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function. | Mean | Standard Deviation | points |
|
| Baseline Decline in ALSFRS-R | The ALS Functional Rating Score-Revised (ALSFRS-R) measures 12 aspects of physical function. Each of the 12 questions assessing distinct functional ability is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function. Baseline is divided by the number of months between onset of weakness due to ALS and the date of Baseline. A higher number indicates greater decline. | Mean | Standard Deviation | points per month |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Delay in ALS Symptom Onset and Diagnosis | Mean | Standard Deviation | months |
|
| SVC | Number analyzed in row differs from overall number due to missing data. | Mean | Standard Deviation | percent predicted |
|
| Serum Cereatinine Concentration | Mean | Standard Deviation | mg/dL |
|
| Time Since Symptom Onsent at Baseline (Months since ALS symptom onset) | Mean | Standard Deviation | months |
|
| Weight | Mean | Standard Deviation | kg |
|
| Serum NfL Concentration | Number analyzed in row differs from overall number due to missing data. | Mean | Standard Deviation | ng/L |
|
| OG001 | Matching Placebo | Matching placebo is administered orally twice daily for 24 weeks. Matching Placebo: Administration: Oral Dose: one capsule twice daily |
|
|
|
| Primary | Mortality Event Rate | Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The rate of mortality was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times. | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Mean | Standard Deviation | events per month | Baseline to 24 Weeks |
|
|
|
| Secondary | Change in Bulbar Function in Participants With Bulbar Dysfunction at Baseline | Change in bulbar function over time in participants with bulbar dysfunction at baseline as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) bulbar subdomain. Each question is scored from 4 (normal) to 0 (no ability), with a maximum total score of 12 and a minimum total score of 0 for the bulbar subdomain. Patients with higher scores have more bulbar function. Participants were classified as having bulbar dysfunction at baseline if their score on the ALSFRS-R bulbar domain (Q1-Q3) score was less than 12. | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Least Squares Mean | Standard Error | point change from baseline | Baseline to 24 Weeks |
|
|
|
|
| Secondary | Bulbar Function in All Randomized Participants | Change in bulbar function over time in all randomized participants as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) bulbar subdomain. Each question is scored from 4 (normal) to 0 (no ability), with a maximum total score of 12 and a minimum total score of 0 for the bulbar subdomain. Patients with higher scores have more bulbar function. | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Least Squares Mean | Standard Error | point change from baseline | Baseline to 24 Weeks |
|
|
|
|
| Secondary | Respiratory Function | Change in respiratory function over time as measured by Slow Vital Capacity (SVC). | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Least Squares Mean | Standard Error | percent change | Baseline to 24 Weeks |
|
|
|
|
| Secondary | Bulbar Function in Participants With Rapid Pre-baseline Progression | Change in bulbar function over time in participants with rapid pre-baseline progression as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) bulbar subdomain. Each question is scored from 4 (normal) to 0 (no ability), with a maximum total score of 12 and a minimum total score of 0 for the bulbar subdomain. Patients with higher scores have more bulbar function. Participants were classified with rapid pre-baseline progression if their change in ALSFRS-R total score between Master Protocol Screening and Regimen Baseline was greater than or equal or 0.75 points per month. | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Least Squares Mean | Standard Error | points change from baseline | Baseline to 24 Weeks |
|
|
|
|
| Secondary | Time to Bulbar Decline | Time to first decline of 1-point or greater post baseline in the ALSFRS-R bulbar domain score among all participants. Analysis performed using interval-censored survival analysis. Results presented as median interval (upper & lower bounded) time to event. | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Median | 95% Confidence Interval | days | Baseline to 24 Weeks |
|
|
|
|
| Secondary | Muscle Strength | Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD). | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Least Squares Mean | Standard Error | percent change | Baseline to 24 Weeks |
|
|
|
|
| Secondary | Number of Participants That Experienced Death or Death Equivalent | The number of participants who died or met the criterion for a death equivalent from the date of their baseline visit to the end of the Week 24visit window (generally 175 days after baseline). The death equivalent criterion is use of permanent assisted ventilation (PAV) for more than 22 hours per day for more than 7 days in a row. | Outcome measure data was analyzed using the Full Analysis Set, which included shared placebo from other regimens, as pre-specified in the Regimen Statistical Analysis Plan. Regimen A (NCT04436497), Regimen B (NCT04436510) and Regimen C (NCT04414345) contributed placebo participants into the shared placebo cohort used for analysis. | Posted | Count of Participants | Participants | Baseline to 24 Weeks |
|
|
|
|
| 2 |
| 120 |
| 16 |
| 121 |
| 106 |
| 121 |
| EG001 | Matching Placebo | Matching placebo is administered orally twice daily for 24 weeks. Matching Placebo: Administration: Oral Dose: one capsule twice daily | 0 | 42 | 3 | 41 | 37 | 41 |
| Syncope | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Cerebellar stroke | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Neuromyopathy | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Clinically Probable ALS - Laboratory Supported |
|
| Clinically Possible ALS |
|
| Generalized |
|
| Limb |
|
| Multiple |
|
| 3 Regions with Neuromuscular Dysfunction |
|
| 4a/4b Nutritional/Respiratory Failure |
|