Prolonged-release Fampridine as adjunct therapy to active enabled motor training in Multiple Sclerosis patients: A pilot, double-blind, placebo-controlled study (P1.123)
Bibliographic record
Abstract
OBJECTIVE: To investigate if multiple sclerosis (MS) subjects treated with prolonged-release Fampridine (PRF) 10mg BID will show a greater benefit from active enabled motor training as compared with subjects treated with placebo. DESIGN/METHODS: Single center, phase 4, pilot, placebo-controlled, double-blind 18 weeks study. 30 MS patients of all types, who satisfied PRF‘s product monograph prescribing criteria, were recruited. Half of the patients were randomized to receive PRF 10mg BID and the other half received placebo BID. All patients participated in active enabled motor training consisting of 3 sessions of 1 hour per week for a period of 6 weeks. All patients then continued taking their medication (PRF or placebo) during a subsequent observational period of 8 weeks. Patients were evaluated at times -4, 0, 6 and 14 weeks using the timed 8 meters walk (8MW), the 6 minute walk (6MW) and the timed sit to stand (STS). RESULTS: Both groups were balanced at baseline. The PRF treated group achieved a higher mean percent improvement from baseline in all three tasks at both the 6 and 14 week time points. The difference reached statistical significance (mean difference of 14.29, p=0.046) for the 8MW at the 14 week time point. A higher incidence of responders (>20[percnt] improvement from baseline) was seen in the PRF treated group at 6 weeks on the 8MW (odds ratio [OR] of 2.31) and the 6MW (OR of 1.63), and at 14 weeks on the 8MW and the STS (OR of 2.0). CONCLUSIONS: PRF in MS patients appears to enhance the benefit of active enabled motor training and to better sustain it over the following 8 weeks. Further studies are warranted. Study Supported by: BiogenIdec
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".