An observational study in Amyotrophic Lateral Sclerosis and Progressive Muscular Atrophy, sponsored by Duke University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Duke University · Observational
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Among 440 studies in Amyotrophic Lateral Sclerosis with a site in United States — 98 open to participants now, 129 under way, 11 of them phase 3. Amyotrophic Lateral Sclerosis · United States.
Among the 440 studies in Amyotrophic Lateral Sclerosis with a site in United States, this one is the 98th largest by enrollment of the 121 observational ones that give a count, is one of 20 that started in 2018, is one of 121 observational ones, and was the 210th registered.
979 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 278 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →98 of the 440 studies in Amyotrophic Lateral Sclerosis with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18–80
Cognixion · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 18+ · Healthy volunteers
Neuralink Corp · Sites in United States
Ages 18+
Biogen · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 193 Amyotrophic Lateral Sclerosis studies recruiting now, 118 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
440 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 89 · Phase 2 139 · Phase 3 48 · Phase 4 1
First in 1982; this study’s year is marked. 20 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 26 is below the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 33 across the 307 interventional studies, 100 across the 121 observational. Of the 277 that completed or were terminated, 102 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
163 of 440 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 8 studies filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
41 of the studies in Amyotrophic Lateral Sclerosis with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07161999Phase 3Coya TherapeuticsStudy of COYA 302 for the Treatment of ALS | 2027-04 |
| NCT04057898Phase 3MediciNovaEvaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS | 2027-04 |
| NCT04297683Phase 3Merit E. Cudkowicz, MDHEALEY ALS Platform Trial - Master Protocol | 2027-07 |
| NCT07410806Phase 3Merit E. Cudkowicz, MDHEALEY ALS Platform Trial - Regimen I NUZ-001 | 2027-07-01 |
| NCT04220190Phase 3Rapa Therapeutics LLCRAPA-501 Therapy for ALS | 2027-07-01 |
Add all 41 to your calendar (.ics) → With an account.
Among the 440 studies in Amyotrophic Lateral Sclerosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to try to understand why reversals of amyotrophic lateral sclerosis (ALS) and primary muscular atrophy (PMA) take place. The study will enroll patients with ALS or PMA reversals to give saliva samples in order to determine if the ALS or PMA reversal is because of certain changes in the genetic code.
Amyotrophic Lateral Sclerosis (ALS) is a devastating motor neuron disease that typically causes rapidly progressive muscle weakness, disability and premature death. In spite of a large number of attempted ALS trials, there are no significant disease-modifying therapies for this condition to-date.
There exists a small group of patients who meet diagnostic criteria for ALS or progressive muscular atrophy (PMA), progress for a period of time, and then significantly improve. Some of these "ALS reversals" even make a complete recovery back to normal neurological function. The investigator has independently verified 34 of these cases so far through review of medical records and peer-reviewed literature. These patients are different in their demographics and disease characteristics as compared to patients with more typically progressive ALS. One possible explanation for these cases is that these patients are genetically different than most patients with ALS and that these differences confer a form of disease "resistance". Study of these selected reversal patients may yield valuable clues to endogenous mechanisms of ALS resistance. The concept of genetic conferred ability to resist a disease is not novel. A group of patients who could unexpectedly "control" HIV due to a mutant allele has led to an improved understanding of HIV pathophysiology and a new treatment
This is a pilot case-control study attempting to discover genetic correlates to ALS reversals. The investigator will collect demographics, disease characteristics, pedigree information and saliva samples from ALS reversals. Whole genome DNA will be extracted and sequenced from these saliva samples. The genomes of ALS reversals will then be compared with whole genome sequencing previously completed from a biorepository of de-identified samples of more typically progressive patients with ALS. The study will not save any saliva samples collected as a part of this new protocol for future research.
Participants will be enrolled by invitation only. Potential participants will have had a previously verified diagnosis of ALS or PMA and a verified sustained and robust reversal of disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
genetic comparison
comparison of genes of participants with ALS reversals to genes of more typically progressive patients with ALS
Time frame: 1 day
factors associated with genes
further genetic analysis for any interaction of demographics, rate of disease progression, or disease characteristics
Time frame: 1 day
Plan to share: Yes — Information obtained from this analysis (genotypic data), as well as information about disease signs and symptoms (phenotypic data), will be entered into one or more scientific repositories maintained by organizations such as the New York Genome Center (NYGC) and the Federal Government. One such repository is the Database of Genotypes and Phenotypes (dbGaP), a data repository at the NIH. All data and information will be submitted via a secure transmission process to a high security network within NIH. While the information and data resulting from this study may be presented at scientific meetings or published in a scientific journal, your name or other personal information will not be revealed.
Ran from Jun 2018 to primary completion in Dec 2023, 65 months.
Of 128 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's 65 months is close to that.
Counting every sponsor, half of 137 studies reached it within 64 months; a quarter within 29 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →