Allos Pharma News - LARVOL Sigma

|||||||||| arbaclofen (STX209) / Allos Pharma
Clinical, Journal: Retinal GABAergic alterations in adults with autism spectrum disorder. (Pubmed Central) - Apr 5, 2024
Participants were administered an oral dose of placebo, 15 or 30?mg of arbaclofen (STX209, GABAB agonist) in a randomized, double-blind, crossover order before the test...The extent of this differential GABAergic function correlated with the extent of autistic traits captured using the Autism Quotient. Thus, sensory processing differences in autism appear to be upstream of more complex autistic traits and the ERG from the retina is a potentially useful proxy for cross-domain brain GABA function and target engagement.

|||||||||| arbaclofen (STX209) / Allos Pharma
Journal: Exploratory evidence for differences in GABAergic regulation of auditory processing in autism spectrum disorder. (Pubmed Central) - Oct 22, 2023
Neurophysiological responses (temporal and frequency domains) to repetitive standard tones and novel deviants presented in an oddball paradigm were compared after double-blind, randomized administration of placebo, 15 or 30?mg of arbaclofen (STX209), a GABA type B (GABA) receptor agonist...Thus, our results confirm: GABAergic dysfunction contributes to the neurophysiology of auditory sensory processing alterations in ASD, and can be modulated by targeting GABA activity. These GABA-dependent sensory differences may be upstream of more complex autistic phenotypes.

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial primary completion date:  Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion (clinicaltrials.gov) -  Apr 19, 2023
P2, N=60, Recruiting,  Sponsor: Clinical Research Associates, LLC
These GABA-dependent sensory differences may be upstream of more complex autistic phenotypes. Trial primary completion date: Aug 2024 --> Dec 2024

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion date, Trial primary completion date:  Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion (clinicaltrials.gov) -  Feb 8, 2023
P2, N=60, Recruiting,  Sponsor: Clinical Research Associates, LLC
Trial primary completion date: Aug 2024 --> Dec 2024 Trial completion date: May 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Aug 2024

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  AIMS2-CT1: Arbaclofen in Children and Adolescents With ASD (clinicaltrials.gov) -  Feb 8, 2023
P2, N=124, Completed,  Sponsor: Celso Arango, MD, PhD
Trial completion date: May 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Aug 2024 Recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment open:  Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion (clinicaltrials.gov) -  Aug 26, 2022
P2, N=60, Recruiting,  Sponsor: Clinical Research Associates, LLC
Recruiting --> Completed Suspended --> Recruiting

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion date, Trial primary completion date:  AIMS2-CT1: Arbaclofen in Children and Adolescents With ASD (clinicaltrials.gov) -  Aug 11, 2022
P2, N=130, Recruiting,  Sponsor: Celso Arango, MD, PhD
Suspended --> Recruiting Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022

|||||||||| arbaclofen (STX209) / Allos Pharma
Clinical, Journal: GABA receptor modulation of visual sensory processing in adults with and without autism spectrum disorder. (Pubmed Central) - Apr 27, 2022
Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022 Steady-state visual evoked potential (SSVEP) elicited by a passive visual surround suppression paradigm was compared after double-blind randomized oral administration of placebo or 15 to 30 mg of arbaclofen (STX209), a GABA type B (GABA) receptor agonist...[Figure: see text].

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Modulation of the Brain Excitatory/Inhibitory (E/I) Balance in Autism Spectrum Disorder (ASD) (clinicaltrials.gov) -  Apr 15, 2022
P=N/A, N=87, Completed,  Sponsor: King's College London
Steady-state visual evoked potential (SSVEP) elicited by a passive visual surround suppression paradigm was compared after double-blind randomized oral administration of placebo or 15 to 30 mg of arbaclofen (STX209), a GABA type B (GABA) receptor agonist...[Figure: see text]. Recruiting --> Completed

|||||||||| arbaclofen (STX209) / Allos Pharma
Preclinical, Journal: The GABAB receptor agonist STX209 reverses the autism‑like behaviour in an animal model of autism induced by prenatal exposure to valproic acid. (Pubmed Central) - Apr 8, 2022
However, expression of glutamic acid decarboxylase 65/67 in the hippocampus were not altered by STX209. The present results demonstrated that STX209 administration ameliorated autism‑like symptoms in mice exposed to VPA prenatally, suggesting that autism‑like symptoms in children with a history of prenatal VPA exposure may also benefit from treatment with the GABABR2 agonist STX209.

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion date, Trial suspension, Trial primary completion date:  Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion (clinicaltrials.gov) -  Aug 18, 2021
P2, N=60, Suspended,  Sponsor: Clinical Research Associates, LLC
The present results demonstrated that STX209 administration ameliorated autism‑like symptoms in mice exposed to VPA prenatally, suggesting that autism‑like symptoms in children with a history of prenatal VPA exposure may also benefit from treatment with the GABABR2 agonist STX209. Trial completion date: May 2022 --> May 2023 | Not yet recruiting --> Suspended | Trial primary completion date: Mar 2022 --> Mar 2023

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion date, Trial primary completion date:  AIMS2-CT1: Arbaclofen in Children and Adolescents With ASD (clinicaltrials.gov) -  Apr 22, 2021
P2, N=130, Recruiting,  Sponsor: Celso Arango, MD, PhD
Trial completion date: May 2022 --> May 2023 | Not yet recruiting --> Suspended | Trial primary completion date: Mar 2022 --> Mar 2023 Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Aug 2021 --> Aug 2022

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion date, Trial primary completion date:  AIMS2-CT1: Arbaclofen in Children and Adolescents With ASD (clinicaltrials.gov) -  May 27, 2020
P2, N=130, Recruiting,  Sponsor: Inge Winter
Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Aug 2021 --> Aug 2022 Trial completion date: Jan 2021 --> Aug 2021 | Trial primary completion date: Jan 2021 --> Aug 2021

||||||||||  arbaclofen (STX209) / Allos Pharma
New P2 trial:  Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion (clinicaltrials.gov) -  Feb 16, 2020
P2, N=60, Not yet recruiting,  Sponsor: Clinical Research Associates, LLC

|||||||||| arbaclofen (STX209) / Seaside Therapeutics
Journal: A MEG Study of Acute Arbaclofen (STX-209) Administration. (Pubmed Central) - Dec 25, 2019
Whether these subjects have a greater trend towards clinical benefit remains to be established. Finally, findings also provide preliminary support for the use of objective electrophysiological measures upon which to base inclusion for optimal enrichment of populations to be included in full-scale clinical trials of arbaclofen.

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion, Enrollment change:  MEG Study of Acute STX209 Effects in ASD (clinicaltrials.gov) -  Oct 21, 2019
P1, N=25, Completed,  Sponsor: Timothy Roberts
Finally, findings also provide preliminary support for the use of objective electrophysiological measures upon which to base inclusion for optimal enrichment of populations to be included in full-scale clinical trials of arbaclofen. Active, not recruiting --> Completed | N=40 --> 25

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment open:  AIMS2-CT1: Arbaclofen in Children and Adolescents With ASD (clinicaltrials.gov) -  Oct 20, 2019
P2, N=130, Recruiting,  Sponsor: Inge Winter
Active, not recruiting --> Completed | N=40 --> 25 Not yet recruiting --> Recruiting

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial initiation date:  AIMS2-CT1: Arbaclofen in Children and Adolescents With ASD (clinicaltrials.gov) -  May 7, 2019
P2, N=130, Not yet recruiting,  Sponsor: Inge Winter
Not yet recruiting --> Recruiting Initiation date: Oct 2018 --> Jun 2019

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial primary completion date:  MEG Study of Acute STX209 Effects in ASD (clinicaltrials.gov) -  Mar 15, 2019
P1, N=40, Active, not recruiting,  Sponsor: Timothy Roberts
Initiation date: Oct 2018 --> Jun 2019 Trial primary completion date: Jan 2019 --> Jul 2019

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment closed, Trial primary completion date:  MEG Study of Acute STX209 Effects in ASD (clinicaltrials.gov) -  Oct 22, 2018
P1, N=40, Active, not recruiting,  Sponsor: Timothy Roberts
Trial primary completion date: Jan 2019 --> Jul 2019 Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2018 --> Jan 2019

||||||||||  arbaclofen (STX209) / Allos Pharma
New P2 trial:  AIMS2-CT1: Arbaclofen in Children and Adolescents With ASD (clinicaltrials.gov) -  Sep 25, 2018
P2, N=130, Not yet recruiting,  Sponsor: Inge Winter

||||||||||  arbaclofen (STX209) / Allos Pharma
New trial:  Modulation of the Brain Excitatory/Inhibitory (E/I) Balance in Autism Spectrum Disorder (ASD) (clinicaltrials.gov) -  Jul 19, 2018
P=N/A, N=100, Recruiting,  Sponsor: King's College London

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment change, Trial primary completion date:  MEG Study of Acute STX209 Effects in ASD (clinicaltrials.gov) -  Aug 16, 2017
P, N=40, Recruiting,  Sponsor: Children's Hospital of Philadelphia
Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2018 --> Jan 2019 N=20 --> 40 | Trial primary completion date: Oct 2017 --> Aug 2018

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial primary completion date:  MEG Study of Acute STX209 Effects in ASD (clinicaltrials.gov) -  Jan 4, 2017
P0, N=20, Recruiting,  Sponsor: Children's Hospital of Philadelphia
N=20 --> 40 | Trial primary completion date: Oct 2017 --> Aug 2018 Trial primary completion date: Apr 2017 --> Oct 2017

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment open:  MEG Study of Acute STX209 Effects in ASD (clinicaltrials.gov) -  Mar 7, 2016
P0, N=20, Recruiting,  Sponsor: Children's Hospital of Philadelphia
Trial primary completion date: Apr 2017 --> Oct 2017 Not yet recruiting --> Recruiting

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial initiation date, Trial primary completion date:  MEG Study of Acute STX209 Effects in ASD (clinicaltrials.gov) -  Dec 29, 2015
P0, N=20, Not yet recruiting,  Sponsor: Children's Hospital of Philadelphia
Not yet recruiting --> Recruiting Initiation date: Oct 2014 --> Jan 2016 | Trial primary completion date: Apr 2016 --> Apr 2017

||||||||||  arbaclofen (STX209) / Allos Pharma
Biomarker, Phase classification:  TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers (clinicaltrials.gov) -  Aug 21, 2015
P1, N=6, Terminated,  Sponsor: Gonzalez-Heydrich, Joseph, M.D.
Initiation date: Oct 2014 --> Jan 2016 | Trial primary completion date: Apr 2016 --> Apr 2017 Phase classification: P1/2 --> P1

||||||||||  arbaclofen (STX209) / Allos Pharma
Biomarker, Trial termination:  TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers (clinicaltrials.gov) -  Sep 2, 2013
P1/2, N=6, Terminated,  Sponsor: Gonzalez-Heydrich, Joseph, M.D.
Phase classification: P1/2 --> P1 Active, not recruiting --> Terminated; too much variability in the TMS measures

||||||||||  arbaclofen (STX209) / Allos Pharma
Biomarker, Enrollment change:  TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers (clinicaltrials.gov) -  Sep 2, 2013
P1/2, N=6, Terminated,  Sponsor: Gonzalez-Heydrich, Joseph, M.D.
Active, not recruiting --> Terminated; too much variability in the TMS measures N=30 --> 6

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial termination:  Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders (clinicaltrials.gov) -  Jul 29, 2013
P3, N=165, Terminated,  Sponsor: Seaside Therapeutics, Inc.
N=30 --> 6 Enrolling by invitation --> Terminated

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial termination:  An Open Label Extension Study in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Jul 29, 2013
P3, N=357, Terminated,  Sponsor: Seaside Therapeutics, Inc.
Enrolling by invitation --> Terminated Enrolling by invitation --> Terminated

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment change:  Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders (clinicaltrials.gov) -  Jul 29, 2013
P2, N=150, Completed,  Sponsor: Seaside Therapeutics, Inc.
Enrolling by invitation --> Terminated N=200 --> 150

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Harbor-C: Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome (clinicaltrials.gov) -  Jul 29, 2013
P3, N=172, Completed,  Sponsor: Seaside Therapeutics, Inc.
N=200 --> 150 Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders (clinicaltrials.gov) -  Jul 29, 2013
P2, N=150, Completed,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Harbor-A: Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome (clinicaltrials.gov) -  Jul 29, 2013
P3, N=125, Completed,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
Biomarker, Trial completion:  Biomarker and DNA Collection in Subjects Participating in Protocol 22003 (clinicaltrials.gov) -  Jul 29, 2013
P=N/A, N=32, Completed,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
Biomarker, Trial completion:  Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001 (clinicaltrials.gov) -  Jul 29, 2013
P=N/A, N=0, Completed,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial termination:  An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders (clinicaltrials.gov) -  Dec 18, 2012
P2, N=32, Terminated,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Enrolling by invitation --> Terminated; all active subjects were rolled into study 209AS209/NCT01706523

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial termination:  An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Dec 18, 2012
P2, N=45, Terminated,  Sponsor: Seaside Therapeutics, Inc.
Enrolling by invitation --> Terminated; all active subjects were rolled into study 209AS209/NCT01706523 Enrolling by invitation --> Terminated; all active subjects rolled into 209FX303/NCT01013480

||||||||||  arbaclofen (STX209) / Allos Pharma
Enrollment change:  An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Dec 18, 2012
P2, N=45, Terminated,  Sponsor: Seaside Therapeutics, Inc.
Enrolling by invitation --> Terminated; all active subjects rolled into 209FX303/NCT01013480 N=60 --> 45

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders (clinicaltrials.gov) -  Dec 18, 2012
P2, N=32, Completed,  Sponsor: Seaside Therapeutics, Inc.
N=60 --> 45 Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
New P3 trial:  Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders (clinicaltrials.gov) -  Oct 11, 2012
P3, N=165, Terminated,  Sponsor: Seaside Therapeutics, Inc.

||||||||||  arbaclofen (STX209) / Allos Pharma
Trial completion:  Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Sep 27, 2012
P2, N=63, Completed,  Sponsor: Seaside Therapeutics, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  arbaclofen (STX209) / Allos Pharma
New P3 trial:  An Open Label Extension Study in Subjects With Fragile X Syndrome (clinicaltrials.gov) -  Mar 13, 2012
P3, N=357, Terminated,  Sponsor: Seaside Therapeutics, Inc.



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