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10 Diseases |  |
0 Trials |
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0 Trials |  |
55 News |  |
- ||||||||| Zalvari (molindone XR) / Supernus Pharma
Trial termination: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) (clinicaltrials.gov) - May 15, 2024
P3, N=491, Terminated, Sponsor: Supernus Pharmaceuticals, Inc.
Completed --> Terminated; The program was shut down due to a lack of efficacy.
- | Zalvari (molindone XR) / Supernus Pharma
Enrollment change: Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment (clinicaltrials.gov) - Feb 19, 2024
P3, N=41, Terminated, Sponsor: Supernus Pharmaceuticals, Inc.
Completed --> Terminated; The program was shut down due to a lack of efficacy. N=186 --> 41
- || Zalvari (molindone XR) / Supernus Pharma
Clinical, Journal: A Double-Blind, Randomized Study of Extended-Release Molindone for Impulsive Aggression in ADHD. (Pubmed Central) - Oct 28, 2021
These results suggest SPN-810 may be effective in reducing residual IA behaviors in children with ADHD. Research is still needed to support the benefit-risk profile of SPN-810 in pediatric populations.
- ||||||| Zalvari (molindone XR) / Supernus Pharma
Trial completion date, Trial termination, Trial primary completion date: Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment (clinicaltrials.gov) - Oct 21, 2020
P3, N=186, Terminated, Sponsor: Supernus Pharmaceuticals, Inc.
Research is still needed to support the benefit-risk profile of SPN-810 in pediatric populations. Trial completion date: Dec 2021 --> Jan 2020 | Recruiting --> Terminated | Trial primary completion date: Jul 2020 --> Jan 2020; Business decision, not related to safety
- ||||||| Zalvari (molindone XR) / Supernus Pharma
Trial completion: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) (clinicaltrials.gov) - Oct 20, 2020
P3, N=491, Completed, Sponsor: Supernus Pharmaceuticals, Inc.
Trial completion date: Dec 2021 --> Jan 2020 | Recruiting --> Terminated | Trial primary completion date: Jul 2020 --> Jan 2020; Business decision, not related to safety Recruiting --> Completed
- || mazindol (NLS-0) - NLS / 1 Pharma, Nolazol (mazindol CR) / NLS Pharma, viloxazine (SPN-812) / Supernus
Clinical, Review, Journal: Beyond stimulants: a systematic review of randomised controlled trials assessing novel compounds for ADHD. (Pubmed Central) - Aug 23, 2020
Expert opinion: The authors found 28 pertinent RCTs of compounds acting on a variety of biological targets, including Dasotraline, Viloxazine (SPN-812), Centanafadine SR (CTN SR), OPC-64005, Fasoracetam (NFC-1, AEVI-001), Metadoxine (MDX), Vortioxetine, Tipepidine Hibenzate, Oxytocin, Sativex (delta-9-tetrahydrocannabinol (THC) plus cannabidiol), Mazindol, and Molindone hydrochloride (SPN-810)...However, they may offer comparable or better tolerability. Additionally, agents acting on etiopathophysiological targets disrupted in specific subgroups of patients with ADHD will move forward the pharmacotherapy of ADHD from a "one size fits all" to a "precision medicine" approach.
- ||||||| Zalvari (molindone XR) / Supernus Pharma
Trial completion, Trial completion date: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) (clinicaltrials.gov) - Nov 29, 2019
P3, N=333, Completed, Sponsor: Supernus Pharmaceuticals, Inc.
Additionally, agents acting on etiopathophysiological targets disrupted in specific subgroups of patients with ADHD will move forward the pharmacotherapy of ADHD from a "one size fits all" to a "precision medicine" approach. Recruiting --> Completed | Trial completion date: Apr 2020 --> Sep 2019
- ||||||| Zalvari (molindone XR) / Supernus Pharma
Trial completion, Trial primary completion date: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) (clinicaltrials.gov) - Nov 29, 2019
P3, N=297, Completed, Sponsor: Supernus Pharmaceuticals, Inc.
Recruiting --> Completed | Trial completion date: Apr 2020 --> Sep 2019 Recruiting --> Completed | Trial primary completion date: May 2018 --> Nov 2019
- | Zalvari (molindone XR) / Supernus Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With Attention-Deficit/Hyperactivity Disorder (clinicaltrials.gov) - Nov 25, 2019
P2, N=14, Terminated, Sponsor: Supernus Pharmaceuticals, Inc.
Recruiting --> Completed | Trial primary completion date: May 2018 --> Nov 2019 N=30 --> 14 | Trial completion date: Mar 2020 --> Nov 2019 | Recruiting --> Terminated | Trial primary completion date: Mar 2020 --> Nov 2019; Financial decision
- ||| Zalvari (molindone XR) / Supernus Pharma
Trial completion date, Trial primary completion date: Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment (clinicaltrials.gov) - Nov 25, 2019
P3, N=186, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
N=30 --> 14 | Trial completion date: Mar 2020 --> Nov 2019 | Recruiting --> Terminated | Trial primary completion date: Mar 2020 --> Nov 2019; Financial decision Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Jul 2019 --> Jul 2020
- || Zalvari (molindone XR) / Supernus Pharma
Enrollment open, Trial completion date, Trial primary completion date: Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With Attention-Deficit/Hyperactivity Disorder (clinicaltrials.gov) - Jun 11, 2019
P2, N=30, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Jul 2019 --> Jul 2020 Not yet recruiting --> Recruiting | Trial completion date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2019 --> Mar 2020
- | Zalvari (molindone XR) / Supernus
Review, Journal: A proposed anti-maladaptive aggression agent classification: improving our approach to treating impulsive aggression. (Pubmed Central) - Apr 5, 2019
Based on these studies we will review how SPN-810 may be well suited for a new, anti-maladaptive aggression drug class and more precisely, a proposed subgroup of IA modulators. The goal of this review is to begin improving the identification of and therapeutic approach for maladaptive aggression as well as IA through more precise anti-maladaptive aggression agent categorization.
- |||| Zalvari (molindone XR) / Supernus Pharma
Trial primary completion date: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) (clinicaltrials.gov) - Apr 4, 2019
P3, N=400, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
The goal of this review is to begin improving the identification of and therapeutic approach for maladaptive aggression as well as IA through more precise anti-maladaptive aggression agent categorization. Trial primary completion date: Mar 2019 --> Mar 2020
- |||| Zalvari (molindone XR) / Supernus Pharma
Trial primary completion date: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) (clinicaltrials.gov) - Apr 4, 2019
P3, N=291, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Trial primary completion date: Mar 2019 --> Mar 2020 Trial primary completion date: Mar 2018 --> Oct 2019
- | Zalvari (molindone XR) / Supernus Pharma
Trial completion date, Trial initiation date, Trial primary completion date: Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With Attention-Deficit/Hyperactivity Disorder (clinicaltrials.gov) - Mar 4, 2019
P2, N=30, Not yet recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Trial primary completion date: Mar 2018 --> Oct 2019 Trial completion date: Dec 2018 --> Dec 2019 | Initiation date: Sep 2018 --> May 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
- | Zalvari (molindone XR) / Supernus Pharma
New P2 trial: Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With Attention-Deficit/Hyperactivity Disorder (clinicaltrials.gov) - Aug 19, 2018
P2, N=30, Not yet recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
- | Zalvari (molindone XR) / Supernus Pharma
Enrollment open: Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment (clinicaltrials.gov) - Aug 7, 2018
P3, N=186, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Trial completion date: Dec 2018 --> Dec 2019 | Initiation date: Sep 2018 --> May 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Not yet recruiting --> Recruiting
- | Zalvari (molindone XR) / Supernus Pharma
New P3 trial: Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment (clinicaltrials.gov) - Jul 24, 2018
P3, N=186, Not yet recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
- |||| Zalvari (molindone XR) / Supernus Pharma
Trial primary completion date: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) (clinicaltrials.gov) - Jul 17, 2017
P3, N=291, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Trial primary completion date: Mar 2017 --> Mar 2018
- |||| Zalvari (molindone XR) / Supernus Pharma
Trial primary completion date: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) (clinicaltrials.gov) - Jul 17, 2017
P3, N=291, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Trial primary completion date: Mar 2017 --> Mar 2018 Trial primary completion date: May 2017 --> May 2018
- |||||| Zalvari (molindone XR) / Supernus Pharma
Enrollment open: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) (clinicaltrials.gov) - Jun 15, 2016
P3, N=400, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Trial primary completion date: May 2017 --> May 2018 Not yet recruiting --> Recruiting
- |||||||||| Zalvari (molindone XR) / Supernus Pharma
New P3 trial: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) (clinicaltrials.gov) - Feb 25, 2016
P3, N=400, Not yet recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
- |||||| Zalvari (molindone XR) / Supernus Pharma
Enrollment open: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) (clinicaltrials.gov) - Feb 12, 2016
P3, N=291, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||| Zalvari (molindone XR) / Supernus Pharma
Enrollment open, Trial initiation date: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) (clinicaltrials.gov) - Feb 12, 2016
P3, N=291, Recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Dec 2015 --> Mar 2015
- |||||||||| Zalvari (molindone XR) / Supernus Pharma
New P3 trial: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) (clinicaltrials.gov) - Dec 2, 2015
P3, N=291, Not yet recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
- |||||||||| Zalvari (molindone XR) / Supernus Pharma
New P3 trial: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) (clinicaltrials.gov) - Dec 2, 2015
P3, N=291, Not yet recruiting, Sponsor: Supernus Pharmaceuticals, Inc.
- Zalvari (molindone XR) / Supernus Pharma
New P1 trial: Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M (clinicaltrials.gov) - Dec 26, 2013
P1, N=7, Completed, Sponsor: Supernus Pharmaceuticals, Inc.
- ||| Zalvari (molindone XR) / Supernus Pharma
Enrollment change: Open-Label, Extension Study to 810P202 (clinicaltrials.gov) - May 21, 2013
P2, N=78, Completed, Sponsor: Supernus Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting | Initiation date: Dec 2015 --> Mar 2015 N=120 --> 78
- |||| Zalvari (molindone XR) / Supernus Pharma
Trial completion: Open-Label, Extension Study to 810P202 (clinicaltrials.gov) - May 9, 2013
P2, N=78, Completed, Sponsor: Supernus Pharmaceuticals, Inc.
N=120 --> 78 Active, not recruiting --> Completed
- |||| Zalvari (molindone XR) / Supernus Pharma
Trial completion: A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - Dec 5, 2012
P2, N=121, Completed, Sponsor: Supernus Pharmaceuticals, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||| Zalvari (molindone XR) / Supernus Pharma
New P2 trial: Open-Label, Extension Study to 810P202 (clinicaltrials.gov) - Aug 10, 2011
P2, N=78, Completed, Sponsor: Supernus Pharmaceuticals, Inc.