Evidence map›Paper›PMID 33164941›Full record

Trial reportJournal of Huntington's disease2020

Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study.

Andrew McGarry, Mika Leinonen, Karl Kieburtz, Michal Geva, C Warren Olanow, Michael Hayden

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of Huntington's disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02006472 (A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02006472 phase2completednot on this map

A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease

TypeinterventionalSponsorPrileniaRan2014 to 2016Enrolled408ConditionsHuntington's DiseaseArmsPridopidine, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Huntington's Disease: Complex Pathogenesis and Therapeutic Strategies.International journal of molecular sciences · 2024
    Review
  10. Article
  11. Development of a Novel σACS chemical neuroscience · 2023
    Article
  12. Article
  13. Development of Fluorescent 4-[4-(3Journal of medicinal chemistry · 2023
    Article
  14. Article
  15. Review
  16. Review
  17. Impact of ER Stress and ER-Mitochondrial Crosstalk in Huntington's Disease.International journal of molecular sciences · 2022
    Review
  18. Current and Possible Future Therapeutic Options for Huntington's Disease.Journal of central nervous system disease · 2022
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Andrew McGarryCooper University Healthcare at Rowan University, Camden, NJ, USA.
Mika LeinonenClintrex Research Corporation, Sarasota, FL, USA.
Karl KieburtzClintrex Research Corporation, Sarasota, FL, USA.
Michal GevaPrilenia Therapeutics, Herzliya, Israel.
C Warren OlanowMount Sinai School of Medicine, New York City, NY, USA.
Michael HaydenPrilenia Therapeutics, Herzliya, Israel.
Icahn School of Medicine at Mount Sinai · USRowan University · USUniversity of British Columbia · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo pharmacological treatment has been demonstrated to provide a functional benefit for persons with Huntington's disease (HD). Pridopidine is a sigma-1-receptor agonist shown to have beneficial effects in preclinical models of HD.

objectiveTo further explore the effect of pridopidine on Total Functional Capacity (TFC) in the recent double-blind, placebo-controlled PRIDE-HD study.

methodsWe performed post-hoc analyses to evaluate the effect of pridopidine on TFC at 26 and 52 weeks. Participants were stratified according to baseline TFC score and analyzed using repeated measures (MMRM) and multiple imputation assuming missing not-at-random (MNAR) and worst-case scenarios.

resultsThe pridopidine 45 mg bid dosage demonstrated a beneficial effect on TFC for the entire population at week 52 of 0.87 (nominal p = 0.0032). The effect was more pronounced for early HD participants (HD1/HD2, TFC = 7-13), with a change from placebo of 1.16 (nominal p = 0.0003). This effect remained nominally significant using multiple imputation with missing not at random assumption as a sensitivity analysis. Responder analyses showed pridopidine 45 mg bid reduced the probability of TFC decline in early HD patients at Week 52 (nominal p = 0.02).

conclusionPridopidine 45 mg bid results in a nominally significant reduction in TFC decline at 52 weeks compared to placebo, particularly in patients with early-stage HD.

Indexed as

Functional StatusActivities of Daily LivingAdultFemaleHumansHuntington DiseaseMaleMiddle AgedPiperidinesReceptors, sigmaSeverity of Illness IndexSigma-1 ReceptorPiperidinespridopidineReceptors, sigmaSigma-1 Receptorclinical trialHuntington’s diseasepridopidinetotal functional capacity

Identifiers

PMID33164941
PMCPMC7836066
OpenAlexW3096226745

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.