ALSFRS-R (ALS Functional Rating Scale)
Neurology· appears in 204+ cited findings in this library
What it is and how the reviews use it
The ALSFRS-R (ALS Functional Rating Scale) is a rating scale used to assess the functional status of individuals with Amyotrophic Lateral Sclerosis (ALS). The ALSFRS-R total score ranges from 0 to 48, as noted in the Biogen Inc. — Qalsody FDA Review (NDA215887, ORIG 1, 2023). It serves as an endpoint in clinical trials to measure changes in disease progression and treatment efficacy.
Regulatory reviews in this library utilize the ALSFRS-R to evaluate drug performance. For instance, in the Biogen B V — Qalsody EMA EPAR public assessment report, the ALSFRS-R change from baseline at Week 28 (mITT population) was 1.2 points. BRAINSTORM CELL THERAPEUTICS INC. reported a baseline ALSFRS-R of 41 in EAP patients in their SEC 8-K filing. Clene Inc.'s SEC 8-K mentioned a least-squares mean difference on CAFS (ALSFRS-R with survival) of 62.6.
Real examples — cited to the source page
| Qalsody | ALSFRS-R change from baseline at Week 28 (mITT population) | 1.2 | Qalsody EMA EPAR, p.63 |
| BRAINSTORM CELL THERAPEUTICS INC. | Baseline ALSFRS-R in EAP patients | 41 | BRAINSTORM CELL THERAPEUTICS INC. — SEC 8-K, p.2 |
| Clene Inc. | least-squares mean difference on CAFS (ALSFRS-R with survival) | 62.6 | Clene Inc. — SEC 8-K, p.3 |
| Qalsody | ALSFRS-R total score range | 0 to 48 | Qalsody FDA Review, p.38 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
Explore the full evidence
Every ALSFRS-R finding in the library — searchable and answerable in plain language — is in the Neurology research library →
Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.