Evidence map›Paper›PMID 34307747›Full record

ArticleMovement disorders clinical practice2021

An Open-Label Phase 2a Study to Evaluate the Safety and Tolerability of Perampanel in Cervical Dystonia.

Susan H Fox, Matthew Swan, Hyder A Jinnah, Maria E T de Freitas, Lais M de Oliveira, Duha Al-Shorafat, Hubert H Fernandez, Katie Kompoliti, Cynthia Comella

Open access · bronzeAbstract read
In one paragraph

Article in Movement disorders clinical practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. An Exploratory, Randomized, Double-Blind Clinical Trial of Dipraglurant for Blepharospasm.Movement disorders : official journal of the Movement Disorder Society · 2024
    Trial
  3. Review
  4. Article
  5. 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

9 authors at 7 institutions in 2 countries.

Susan H FoxThe Edmond J Safra Program in Parkinson Disease, Toronto Western Hospital Toronto Ontario Canada.
Matthew SwanMount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai New York New York USA.
Hyder A JinnahDepartment of Human Genetics and Pediatrics Emory University Atlanta Georgia USA.
Maria E T de FreitasThe Edmond J Safra Program in Parkinson Disease, Toronto Western Hospital Toronto Ontario Canada.
Lais M de OliveiraThe Edmond J Safra Program in Parkinson Disease, Toronto Western Hospital Toronto Ontario Canada.
Duha Al-ShorafatThe Edmond J Safra Program in Parkinson Disease, Toronto Western Hospital Toronto Ontario Canada.
Hubert H FernandezCleveland Clinic Cleveland Ohio USA.
Katie KompolitiRush University Medical Centre Chicago Illinois USA.
Cynthia ComellaRush University Medical Centre Chicago Illinois USA.
Ontario Brain Institute · CARush University Medical Center · USCleveland Clinic · USEmory University · USMount Sinai Beth Israel · USUniversity Health Network · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCervical dystonia (CD) is the most common focal isolated dystonia. Preclinical studies report that AMPA-selective glutamate receptor antagonists improve dystonia. Perampanel is a clinically available, AMPA receptor antagonist that has shown efficacy and safety in epilepsy.

objectivesTo determine safety and tolerability of perampanel in CD.

methodsWe performed a phase 2a, open-label, multicenter study to evaluate tolerability and safety of perampanel in CD. Included subjects had primary CD; those on botulinum toxin were 8 weeks post last injection. All subjects received perampanel 2 mg/day, titrated 2 mg weekly over 6 weeks, to maximum 12 mg/day; maintenance phase was 4 weeks, ending at week 10. Primary endpoints included tolerability, defined as ability to remain on perampanel for the maintenance period, at any dose level and safety, determined from adverse events (AEs) collected at each visit. Secondary exploratory endpoints included Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), quality of life (cervical dystonia impact profile [CIDP]-58) and Clinical Global Impression of change (CGI).

resultsCD participants (n = 25) were recruited. Eight subjects withdrew; 4 because of AEs, 3 for other reasons and 1 lost to follow up. One subject tolerated 12 mg/day. Eight subjects (30.8%) tolerated 2 mg, whereas 19.2% tolerated 4 mg/day, and 15.4% tolerated 6 mg or 8 mg/day. All subjects experienced AEs. The most common AEs were dizziness, imbalance, and irritability. Exploratory endpoints of TWSTRS showed some improved pain scores and CIDP-58 improved sleep.

conclusionsTolerability to perampanel was variable in CD subjects. Lower doses would be considered for future studies in this population.

Indexed as

AMPA antagonistcervical dystoniaclinical trialperampanelTWSTRS

Identifiers

PMID34307747
PMCPMC8287187
OpenAlexW3159266731

What OpenQuestion holds

Textmetadata
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.