Evidence map›Paper›PMID 31027422›Full record

Trial reportAutism : the international journal of research and practice2019

Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies.

Antonio Y Hardan, Robert L Hendren, Michael G Aman, Adelaide Robb, Raun D Melmed, Kristen A Andersen, Rachel Luchini, Rezwanur Rahman, Sanjida Ali, X Daniel Jia and 4 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Autism : the international journal of research and practice, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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

20 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Memantine for autism spectrum disorder.The Cochrane database of systematic reviews · 2022
    Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Memantine Use in Prolonged Cognitive Sequalae in Pediatric Anti-N-methyl-D-aspartate Receptor Encephalitis: A Three-year Follow-up Case Report and Brief Review.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2026
    Article
  9. Novel therapeutics in autism spectrum disorder.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  10. Article
  11. Treatment of Catatonia with Benzodiazepine, Electroconvulsive Therapy and Memantine in an Adolescent: a Case Report.Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent · 2025
    Article
  12. Article
  13. Review
  14. Nutrients · 2022
    Article
  15. Autism Spectrum Disorder: Focus on Glutamatergic Neurotransmission.International journal of molecular sciences · 2022
    Review
  16. Chloride imbalance in Fragile X syndrome.Frontiers in neuroscience · 2022
    Article
  17. Decades of Progress in the Psychopharmacology of Autism Spectrum Disorder.Journal of autism and developmental disorders · 2021
    Article
  18. Review
  19. Article
  20. Overlapping Molecular Pathways Leading to Autism Spectrum Disorders, Fragile X Syndrome, and Targeted Treatments.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 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.

Antonio Y HardanStanford University, USA.
Robert L HendrenUniversity of California, San Francisco, USA.
Michael G AmanOhio State University, USA.
Adelaide RobbChildren's National Medical Center, USA.
Raun D MelmedSouthwest Autism Research & Resource Center, USA.
Kristen A AndersenPrescott Medical Communications Group, USA.
Rachel LuchiniAllergan plc, USA.
Rezwanur RahmanAllergan plc, USA.
Sanjida AliAllergan plc, USA.
X Daniel JiaAllergan plc, USA.
Madhuja MallickAllergan plc, USA.
Jordan E LateinerAllergan plc, USA.
Robert H PalmerAllergan plc, USA.
Stephen M GrahamForest Research Institute (currently Allergan plc), USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Three phase 2 trials were conducted to assess the efficacy and long-term safety of weight-based memantine extended release (ER) treatment in children with autism spectrum disorder. MEM-MD-91, a 50-week open-label trial, identified memantine extended-release treatment responders for enrollment into MEM-MD-68, a 12-week randomized, double-blind, placebo-controlled withdrawal trial. MEM-MD-69 was an open-label extension trial in which participants from MEM-MD-68, MEM-MD-91, and open-label trial MEM-MD-67 were treated ⩽48 weeks with memantine extended release. In MEM-MD-91, 517 (59.6%) participants were confirmed Social Responsiveness Scale responders at week 12; mean Social Responsiveness Scale total raw scores improved two to three times a minimal clinically important difference of 10 points. In MEM-MD-68, there was no difference between memantine and placebo on the primary efficacy parameter, the proportion of patients with a loss of therapeutic response (defined as ⩾10-point increase from baseline in Social Responsiveness Scale total raw score). MEM-MD-69 exploratory analyses revealed mean standard deviation improvement in Social Responsiveness Scale total raw score of 32.4 (26.4) from baseline of the first lead-in study. No new safety concerns were evident. While the a priori-defined efficacy results of the double-blind trial were not achieved, the considerable improvements in mean Social Responsiveness Scale scores from baseline in the open-label trials were presumed to be clinically important.

Indexed as

Social BehaviorAutism Spectrum DisorderChildDelayed-Action PreparationsDouble-Blind MethodEarly Termination of Clinical TrialsExcitatory Amino Acid AntagonistsFemaleFeverHeadacheHumansIrritable MoodMaleMemantineNasopharyngitisTreatment OutcomeDelayed-Action PreparationsExcitatory Amino Acid AntagonistsMemantineAsperger’s disorderautism spectrum disordersclinical trialmedicationmemantinepervasive developmental disorder-not otherwise specifiedrandomized withdrawalschool-age childrenSocial Responsiveness Scale

Identifiers

PMID31027422
PMCPMC6779018

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.