Intuniv (guanfacine XR) / Shionogi, Takeda 
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 14 Diseases   10 Trials   10 Trials   201 News 


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  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion:  ADAPT: ADHD Medication and Predictors of Treatment Outcome (clinicaltrials.gov) -  Oct 17, 2023   
    P=N/A,  N=632, Completed, 
    Supratherapeutic serum guanfacine concentrations may induce QT prolongation. Active, not recruiting --> Completed
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed:  A Trial of Guanfacine-er for Cannabis Use Disorder (clinicaltrials.gov) -  Aug 14, 2023   
    P2,  N=90, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion:  Drug Use Study With Intuniv (clinicaltrials.gov) -  Aug 4, 2023   
    P=N/A,  N=5000, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    New trial:  Drug Use Study With Intuniv (clinicaltrials.gov) -  May 23, 2023   
    P=N/A,  N=5000, Active, not recruiting, 
  • ||||||||||  Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial termination:  An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) -  Feb 2, 2023   
    P=N/A,  N=38, Terminated, 
    Trial completion date: Feb 2023 --> Jan 2024 | Trial primary completion date: Feb 2023 --> Jan 2024 Completed --> Terminated; Recruitment/enrollment ended early due to the COVID-19 pandemic
  • ||||||||||  Vyvanse (lisdexamfetamine) / Shionogi, Takeda
    Enrollment closed, Trial completion date:  AGUALIS: Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents (clinicaltrials.gov) -  Aug 17, 2022   
    P=N/A,  N=20, Active, not recruiting, 
    Completed --> Terminated; Recruitment/enrollment ended early due to the COVID-19 pandemic Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Mar 2025
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) -  Aug 1, 2022   
    P4,  N=288, Recruiting, 
    The NorAD trial aims to determine whether guanfacine, a noradrenergic alpha-2 agonist, improves attention and cognition when used in addition to standard cholinergic treatment. Trial completion date: May 2025 --> Dec 2025 | Trial primary completion date: May 2025 --> Dec 2025
  • ||||||||||  Qelbree (viloxazine) / Supernus Pharma
    Review, Journal:  Nonstimulant Treatments for ADHD. (Pubmed Central) -  Jun 21, 2022   
    We present detailed information regarding the 4 FDA-approved nonstimulant medications-the norepinephrine reuptake inhibitors, atomoxetine and viloxazine extended release, and the α-2 adrenergic agonists, clonidine XR and guanfacine XR...Variability across and within drug classes in nature of response, approach to titration, and temporal characteristics of treatment allow a nuanced treatment approach for individuals with comorbid disorders and complicated clinical presentations. Availability of nonstimulant medications enhances our opportunity to offer personalized treatment of ADHD across the lifespan.
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment open:  A Trial of Guanfacine-er for Cannabis Use Disorder (clinicaltrials.gov) -  Jun 8, 2022   
    P2,  N=90, Recruiting, 
    Availability of nonstimulant medications enhances our opportunity to offer personalized treatment of ADHD across the lifespan. Not yet recruiting --> Recruiting
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (clinicaltrials.gov) -  Apr 6, 2022   
    P4,  N=200, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) -  Apr 6, 2022   
    P=N/A,  N=120, Active, not recruiting, 
    Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    New P2 trial:  A Trial of Guanfacine-er for Cannabis Use Disorder (clinicaltrials.gov) -  Mar 10, 2022   
    P2,  N=90, Not yet recruiting, 
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment change:  Guanfacine Clinical Trial for Smoking Cessation (clinicaltrials.gov) -  Dec 29, 2021   
    P2,  N=121, Completed, 
    Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 N=250 --> 121
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Alpha-2 Agonists In Children And Adolescents With Ptsd: A Systematic Review () -  Dec 18, 2021 - Abstract #AACAP2021AACAP_934;    
    No double-blind placebo-controlled trial was found during the literature search.Conclusions Alpha-2 agonists (clonidine and guanfacine) have shown to be effective in treating symptoms associated with PTSD in children and adolescents. Future placebo-controlled trials are needed to assess the efficacy and safety of alpha-2 agonists.PPC, TRA, TREAT
  • ||||||||||  Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion, Enrollment change, Trial completion date:  An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) -  Dec 14, 2021   
    P=N/A,  N=38, Completed, 
    Future placebo-controlled trials are needed to assess the efficacy and safety of alpha-2 agonists.PPC, TRA, TREAT Active, not recruiting --> Completed | N=160 --> 38 | Trial completion date: Sep 2022 --> Nov 2021
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  ADAPT: ADHD Medication and Predictors of Treatment Outcome (clinicaltrials.gov) -  Oct 8, 2021   
    P=N/A,  N=632, Active, not recruiting, 
    The findings demonstrate the efficacy of GXR for treating ADHD in children and adolescents with comorbid ODD. Enrolling by invitation --> Active, not recruiting | N=2000 --> 632 | Trial completion date: Jan 2022 --> Jul 2022 | Trial primary completion date: Apr 2021 --> Jul 2021
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion:  Drug Use Study With Intuniv® in Australia (clinicaltrials.gov) -  Oct 4, 2021   
    P=N/A,  N=100, Completed, 
    In Canadian routine clinical practice, most children and adolescents with ADHD treated with GXR experienced improvements in ADHD symptoms and in functionality both at school and at home. Active, not recruiting --> Completed
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Journal:  Guanfacine's Mechanism of Action in Treating Prefrontal Cortical Disorders: Successful Translation Across Species. (Pubmed Central) -  Sep 29, 2021   
    In addition to therapeutic actions in PFC, stress-related disorders may also benefit from additional α2-AR actions, such as weakening plasticity in the amygdala, reducing NE release, and anti-inflammatory actions by deactivating microglia. Altogether, these NE α2-AR actions optimize top-down control by PFC networks, which may explain guanfacine's benefits in a variety of mental disorders.
  • ||||||||||  Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed:  An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) -  Aug 24, 2021   
    P=N/A,  N=160, Active, not recruiting, 
    Altogether, these NE α2-AR actions optimize top-down control by PFC networks, which may explain guanfacine's benefits in a variety of mental disorders. Recruiting --> Active, not recruiting
  • ||||||||||  methylphenidate tablet / Generic mfg.
    Journal:  Not Really "The Same Thing". (Pubmed Central) -  May 1, 2021   
    Susie's parents contacted the pharmacy and were told that Susie's prescription was filled with "the same thing as before." The pharmacist explained that the tablets looked different because the manufacturer had changed in order to comply with the preferences of Susie's insurance provider. What would be your next steps in Susie's care?
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    New trial:  Drug Use Study With Intuniv® in Australia (clinicaltrials.gov) -  Apr 29, 2021   
    P,  N=100, Active, not recruiting, 
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial withdrawal:  Guanfacine Extended Release and Mindfulness Skills Therapy (clinicaltrials.gov) -  Mar 8, 2021   
    P4,  N=0, Withdrawn, 
    What would be your next steps in Susie's care? Terminated --> Withdrawn
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed, Trial primary completion date:  Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) -  Feb 23, 2021   
    P=N/A,  N=120, Active, not recruiting, 
    Terminated --> Withdrawn Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Dec 2021
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed, Trial completion date, Trial primary completion date:  Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (clinicaltrials.gov) -  Feb 23, 2021   
    P4,  N=200, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Dec 2021 Recruiting --> Active, not recruiting | Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
  • ||||||||||  Vyvanse (lisdexamfetamine) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  AGUALIS: Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents (clinicaltrials.gov) -  Feb 21, 2021   
    P=N/A,  N=20, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2022
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  Noradrenergic Add-on Therapy With Guanfacine (clinicaltrials.gov) -  Feb 18, 2021   
    P3,  N=160, Recruiting, 
    Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2022 Trial completion date: Mar 2021 --> Dec 2022 | Trial primary completion date: Mar 2021 --> Dec 2022
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion:  Guanfacine Clinical Trial for Smoking Cessation (clinicaltrials.gov) -  Jan 6, 2021   
    P2,  N=250, Completed, 
    G-XR is a feasible treatment for CUDs, and should be evaluated further in an efficacy trial. Active, not recruiting --> Completed
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) -  Sep 22, 2020   
    P4,  N=288, Recruiting, 
    After long-term treatment, patients had significant improvements from baseline in ADHD symptoms, QoL, and executive functioning. Trial completion date: Apr 2024 --> May 2025 | Trial primary completion date: Apr 2024 --> May 2025
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial primary completion date:  ADAPT: ADHD Medication and Predictors of Treatment Outcome (clinicaltrials.gov) -  Sep 7, 2020   
    P=N/A,  N=2000, Enrolling by invitation, 
    Trial completion date: Apr 2024 --> May 2025 | Trial primary completion date: Apr 2024 --> May 2025 Trial primary completion date: Dec 2020 --> Apr 2021