Evidence map›Paper›PMID 33764619›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2021

A Phase 2 Proof-of-Concept, Randomized, Placebo-Controlled Trial of CX-8998 in Essential Tremor.

Spyros Papapetropoulos, Margaret S Lee, Stacey Versavel, Evan Newbold, Hyder A Jinnah, Rajesh Pahwa, Kelly E Lyons, Rodger Elble, William Ondo, Theresa Zesiewicz and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.5field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 27 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Novel and experimental therapeutics for the management of motor and non-motor Parkinsonian symptoms.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Essential tremor: Clinical perspectives and pathophysiology.Journal of the neurological sciences · 2022
    Review
  12. Review
  13. Review
  14. Is the inferior olive central to essential tremor? Yes.International review of neurobiology · 2022
    Article
  15. Article
  16. Essential tremor.Nature reviews. Disease primers · 2021
    Review
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

14 authors at 12 institutions in 1 country.

Spyros Papapetropoulos *Massachusetts General Hospital, Boston, Massachusetts, USA.
Margaret S Lee *Jazz Pharmaceuticals, Philadelphia, Pennsylvania, USA.
Stacey VersavelCerevel Therapeutics, LLC, Boston, Massachusetts, USA.
Evan NewboldJazz Pharmaceuticals, Philadelphia, Pennsylvania, USA.
Hyder A JinnahEmory University School of Medicine, Atlanta, Georgia, USA.
Rajesh PahwaUniversity of Kansas Medical Center, Kansas City, Kansas, USA.
Kelly E LyonsUniversity of Kansas Medical Center, Kansas City, Kansas, USA.
Rodger ElbleSouthern Illinois University School of Medicine, Springfield, Illinois, USA.
William OndoHouston Methodist Neurological Institute, Houston, Texas, USA.
Theresa ZesiewiczUniversity of South Florida Ataxia Research Center, Tampa, Florida, USA.
Peter HederaDepartment of Neurology, University of Louisville, Louisville, Kentucky, USA.
Adrian HandforthVA Greater Los Angeles Healthcare System, Los Angeles, California, USA.
Jenna ElderPharPoint Research, Inc., Wilmington, North Carolina, USA.
Mark VersavelvZenium, LLC, Arlington, Massachusetts, USA.
Jazz Pharmaceuticals (United States) · USUniversity of Kansas Medical Center · USCerevel Therapeutics (United States) · USEmory University · USHouston Methodist · USMassachusetts General Hospital · USMillennium Engineering and Integration (United States) · USSouthern Illinois University School of Medicine · USUniversity of Louisville · USUniversity of South Florida · USVA Greater Los Angeles Healthcare System · USWilmington University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAvailable essential tremor (ET) therapies have limitations.

objectivesThe objective of this study was to evaluate CX-8998, a selective T-type calcium channel modulator, in essential tremor.

methodsPatients 18-75 years old with moderate to severe essential tremor were randomized 1:1 to receive CX-8998 (titrated to 10 mg twice daily) or placebo. The primary end point was change from baseline to day 28 in The Essential Tremor Rating Assessment Scale performance subscale scored by independent blinded video raters. Secondary outcomes included in-person blinded investigator rating of The Essential Tremor Rating Assessment Scale performance subscale, The Essential Tremor Rating Assessment Scale activities of daily living subscale, and Kinesia ONE accelerometry.

resultsThe video-rated The Essential Tremor Rating Assessment Scale performance subscale was not different for CX-8998 (n = 39) versus placebo (n = 44; P = 0.696). CX-8998 improved investigator-rated The Essential Tremor Rating Assessment Scale performance subscale (P = 0.017) and The Essential Tremor Rating Assessment Scale activities of daily living (P = 0.049) but not Kinesia ONE (P = 0.421). Adverse events with CX-8998 included dizziness (21%), headache (8%), euphoric mood (6%), and insomnia (6%).

conclusionsThe primary efficacy end point was not met; however, CX-8998 improved some assessments of essential tremor, supporting further clinical investigation. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. This article has been contributed to by US Government employees and their work is in the public domain in the USA.

Indexed as

Essential TremorActivities of Daily LivingDouble-Blind MethodHumansTreatment OutcomeCX-8998essential tremorphase 2 trialT-CALMT-Type calcium channel modulator

Identifiers

PMID33764619
PMCPMC8451783
OpenAlexW3137628564

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.