Evidence map›Paper›PMID 29339723›Full record

ArticleNature communications2018

Fasoracetam in adolescents with ADHD and glutamatergic gene network variants disrupting mGluR neurotransmitter signaling.

Josephine Elia, Grace Ungal, Charlly Kao, Alexander Ambrosini, Nilsa De Jesus-Rosario, Lene Larsen, Rosetta Chiavacci, Tiancheng Wang, Christine Kurian, Kanani Titchen and 14 more

Registry-linked trialOpen access · goldAbstract readControlled Clinical Trial
In one paragraph

Article in Nature communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02286817 (Phase I Single Dose, Open-label, Pharmacokinetic Study Followed by Single-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Plasma Concentration Profiles, and Targeted Efficacy of NFC-1 in Adolescents), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT02286817 phase1completednot on this map

Phase I Single Dose, Open-label, Pharmacokinetic Study Followed by Single-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Plasma Concentration Profiles, and Targeted Efficacy of NFC-1 in Adolescents (12-17 Years of Age) With Attention-Deficit Hyperactivity Disorder and Genetic Disruption Impacting Metabotropic Glutamate Receptor Genes (NFC1-GREAT)

TypeinterventionalSponsorAevi Genomic Medicine, LLC, a Cerecor companyRan2015 to 2016Enrolled30ConditionsAttention-deficit Hyperactivity Disorder (ADHD)ArmsNFC-1
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Pooled it
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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

24 authors at 5 institutions in 1 country.

Josephine EliaNemours, du Pont Hospital for Children, Wilmington, 19803, DE, USA. Josephine.Elia@nemours.org.
Grace UngalDrexel University College of Medicine, Philadelphia, 19129, PA, USA.
Charlly KaoThe Center for Applied Genomics, The Children's Hospital of Philadelphia, Philadelphia, 19104, PA, USA.
Alexander AmbrosiniUniversity of Pennsylvania, Philadelphia, 19104, PA, USA.
Nilsa De Jesus-RosarioDepartment of Psychiatry Sidney Kimmel Medical College of Thomas Jefferson University, 19107, Philadelphia, USA.
Lene LarsenDepartment of Psychiatry Sidney Kimmel Medical College of Thomas Jefferson University, 19107, Philadelphia, USA.
Rosetta ChiavacciThe Center for Applied Genomics, The Children's Hospital of Philadelphia, Philadelphia, 19104, PA, USA.
Tiancheng WangThe Center for Applied Genomics, The Children's Hospital of Philadelphia, Philadelphia, 19104, PA, USA.
Christine KurianDepartment of Pediatrics Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, 19107, PA, USA.
Kanani TitchenNemours, du Pont Hospital for Children, Wilmington, 19803, DE, USA.
Brian SykesNemours, du Pont Hospital for Children, Wilmington, 19803, DE, USA.
Sharon HwangNemours, du Pont Hospital for Children, Wilmington, 19803, DE, USA.
Bhumi KumarNemours, du Pont Hospital for Children, Wilmington, 19803, DE, USA.
Jacqueline PottsDepartment of Pediatrics Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, 19107, PA, USA.
Joshua DavisNemours, du Pont Hospital for Children, Wilmington, 19803, DE, USA.
Jeffrey MalatackNemours, du Pont Hospital for Children, Wilmington, 19803, DE, USA.
Emma SlatteryDepartment of Pediatrics Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, 19107, PA, USA.
Ganesh MoorthyDepartment of Pediatrics Perelman School of Medicine, University of Pennsylvania, Philadelphia, 19104, PA, USA.
Athena ZuppaDepartment of Pediatrics Perelman School of Medicine, University of Pennsylvania, Philadelphia, 19104, PA, USA.
Andrew WellerDepartment of Psychiatry Sidney Kimmel Medical College of Thomas Jefferson University, 19107, Philadelphia, USA.
Enda ByrneThe Center for Applied Genomics, The Children's Hospital of Philadelphia, Philadelphia, 19104, PA, USA.
Yun R LiThe Center for Applied Genomics, The Children's Hospital of Philadelphia, Philadelphia, 19104, PA, USA.
Walter K KraftDepartment of Pediatrics Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, 19107, PA, USA.ORCID http://orcid.org/0000-0002-5074-0141
Hakon HakonarsonThe Center for Applied Genomics, The Children's Hospital of Philadelphia, Philadelphia, 19104, PA, USA.
Thomas Jefferson University · USChildren's Hospital of Philadelphia · USUniversity of Pennsylvania · USCommunity Health Systems - Dupont Hospital · USDrexel University · US

Funding

The Intellectual and Developmental Disabilities Research Center at CHOP/PennU54HD086984 · NICHD · CHILDREN'S HOSP OF PHILADELPHIA · PI SCHULTZ, ROBERT THOMAS · 2016 to 2020
$6.3M
NICHD NIH HHS U54 HD086984
6 · The paper itself

Abstract

The glutamatergic neurotransmitter system may play an important role in attention-deficit hyperactivity disorder (ADHD). This 5-week, open-label, single-blind, placebo-controlled study reports the safety, pharmacokinetics and responsiveness of the metabotropic glutamate receptor (mGluR) activator fasoracetam (NFC-1), in 30 adolescents, age 12-17 years with ADHD, harboring mutations in mGluR network genes. Mutation status was double-blinded. A single-dose pharmacokinetic profiling from 50-800 mg was followed by a single-blind placebo at week 1 and subsequent symptom-driven dose advancement up to 400 mg BID for 4 weeks. NFC-1 treatment resulted in significant improvement. Mean Clinical Global Impressions-Improvement (CGI-I) and Severity (CGI-S) scores were, respectively, 3.79 at baseline vs. 2.33 at week 5 (P < 0.001) and 4.83 at baseline vs. 3.86 at week 5 (P < 0.001). Parental Vanderbilt scores showed significant improvement for subjects with mGluR Tier 1 variants (P < 0.035). There were no differences in the incidence of adverse events between placebo week and weeks on active drug. The trial is registered at https://clinicaltrials.gov/ct2/show/study/NCT02286817 .

Indexed as

AdolescentArea Under CurveAttention Deficit Disorder with HyperactivityChildDose-Response Relationship, DrugDouble-Blind MethodExcitatory Amino Acid AgentsFemaleHalf-LifeHumansMaleMutationReceptors, Metabotropic GlutamateSingle-Blind MethodExcitatory Amino Acid AgentsReceptors, Metabotropic Glutamate

Identifiers

PMID29339723
PMCPMC5770454
OpenAlexW2779838823

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.