J010 Integrated efficacy analysis of four randomized placebo-controlled trials supports pridopidine’s significant and consistent treatment benefits across key clinical measures of Huntington’s disease
Bibliographic record
Abstract
Background In PROOF-HD, pridopidine improved key measures of HD clinical progression (cUHDRS), function (TFC), cognition (SWR), and motor (Q-Motor). Aim To determine if results from prior HD studies with pridopidine are consistent with PROOF-HD. Methods An analysis was performed on 435 participants off antidopaminergic medications (ADMs) (placebo n=227; pridopidine n=208) from four randomized, double-blind, placebo-controlled trials (HART, MermaiHD, PRIDE-HD and PROOF-HD) assessing pridopidine (45mg bid) in early HD patients (TFC≥7). Results Pridopidine showed robust improvement vs placebo in TFC through week 78, reaching nominal significance at weeks 26 (Δ0.31, p=0.03), 39 (Δ0.43, p=0.01), 52 (Δ0.38, p=0.02), and 78 (Δ0.49, p=0.02). As PRIDE-HD did not measure SWR, cUHDRS is unavailable; therefore, a revised cUHDRS excluding SWR was used. Pridopidine shows meaningful benefits in cUHDRS(-SWR) through week 78, reaching nominal significance at weeks 26 (Δ0.30, p=0.006), 39 (Δ0.45, p=0.002), and 52 (Δ0.29, p=0.04). All of the trials contribute positively to the observed benefits. Pridopidine improves all measures of Q-Motor Finger Tapping (FT) and Pronation Supination (Pro_Sup) through week 78. These include improvements from baseline in FT through week 52, with nominal significant benefits at weeks 12 (Δ-31msec, p=0.046), 26 (Δ-27msec, p<0.001), 52 (Δ-25msec, p=0.02), and 78 (Δ-25msec, p=0.05). Similar benefits are seen for Pro_Sup. In additional analyses of subjects on low dose ADMs, as per the regulatory label when used in the presence of a CYP2D6 inhibitor such as pridopidine, the positive effects of pridopidine are maintained. Conclusion This pooled analysis supports and validates PROOF-HD findings of consistent, sustained, and clinically meaningful benefits of pridopidine in HD.
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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 | 0.057 | 0.068 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.011 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 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".