NCT01813318

Study of Acamprosate in Autism

Completed Phase 1 Last updated 3 February 2021

What this trial tests

Phase 1 trial testing Acamprosate in Autistic Disorder in 36 participants. Completed in 7 September 2017.

Timeline

2 July 2013

Primary endpoint
7 September 2017

7 September 2017

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	36
Start date	2 July 2013
Primary completion	7 September 2017
Estimated completion	7 September 2017
Sites	1 location across United States

Drugs / interventions tested

• Acamprosate (ACAMPROSATE) — full drug profile →
• Placebo

Conditions studied

• Autistic Disorder — all drugs for Autistic Disorder →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 5 to 17, any sex, with Autistic Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recent pharmacotherapy research in autism spectrum disorders (ASD) has successfully focused on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability that commonly occur in persons with ASD. Despite over two decades of significant pharmacotherapy research, to date no medication has been shown in controlled trials to enhance the core social deficits of ASD. Based upon findings describing the neurobiology of ASD combined with our preliminary results, we believe the novel drug acamprosate will show evidence of reducing social skills deficits associated with ASD.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signalling pathways in autism spectrum disorder: mechanisms and therapeutic implications.
   Jiang CC, Lin LS, Long S, Ke XY, et al · · 2022 · cited 157× · PMID 35817793 · DOI 10.1038/s41392-022-01081-0
2. The role of glutamate and its receptors in autism and the use of glutamate receptor antagonists in treatment.
   Rojas DC. · · 2014 · cited 137× · PMID 24752754 · DOI 10.1007/s00702-014-1216-0
3. Translational Mouse Models of Autism: Advancing Toward Pharmacological Therapeutics.
   Kazdoba TM, Leach PT, Yang M, Silverman JL, et al · · 2016 · cited 136× · PMID 27305922 · DOI 10.1007/7854_2015_5003
4. Impact of acamprosate on plasma amyloid-β precursor protein in youth: a pilot analysis in fragile X syndrome-associated and idiopathic autism spectrum disorder suggests a pharmacodynamic protein marker.
   Erickson CA, Ray B, Maloney B, Wink LK, et al · · 2014 · cited 38× · PMID 25300441 · DOI 10.1016/j.jpsychires.2014.07.011
5. Social Communication is an Emerging Target for Pharmacotherapy in Autism Spectrum Disorder - A Review of the Literature on Potential Agents.
   Baribeau DA, Anagnostou E. · · 2014 · cited 12× · PMID 24516474
6. Chemical Modulators for Targeting Autism Spectrum Disorders: From Bench to Clinic.
   Lim S, Lee S. · · 2022 · cited 6× · PMID 36014340 · DOI 10.3390/molecules27165088