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- || luvadaxistat (NBI-1065844) / Neurocrine
Biomarker, Clinical, Observational data, Retrospective data, Review, Journal: Therapeutic potential of D-amino acid oxidase inhibitors for cognitive impairment associated with schizophrenia: learnings from luvadaxistat. (Pubmed Central) - Jan 12, 2025
In this review, we provide an overview of the evidence supporting the potential of NMDAR modulators in general, and DAAO inhibitors in particular, as potential adjunctive treatments for schizophrenia. We also discuss the preclinical and clinical data related to luvadaxistat, an investigational highly selective and potent DAAO inhibitor that was under development for the treatment of the cognitive impairment associated with schizophrenia.
- || luvadaxistat (NBI-1065844) / Neurocrine, iclepertin (BI425809) / Boehringer Ingelheim, bitopertin (DISC-1459) / Disc Medicine
PK/PD data, Review, Journal: Finding the right dose: NMDAR modulating treatments for cognitive and plasticity deficits in schizophrenia and the role of pharmacodynamic target engagement. (Pubmed Central) - Dec 11, 2024
A range of direct and indirect NMDAR modulators will be covered, including d-serine, d-cycloserine, memantine, glycine and "first generation" glycine transport inhibitors (GTI, e.g. sarcosine and bitopertin), as well as recent positive studies of iclepertin, a novel GTI and luvadaxistat, a D-amino acid oxidase inhibitor (DAAO-I) that increases brain d-serine levels and indirect non-invasive brain stimulation NMDAR modulating treatments. Several examples of successful use of pharmacodynamic target engagement biomarkers for dose/drug discovery will be emphasized, including mismatch negativity (MMN), auditory steady state (ASSR) and time-frequency event-related potential (TF-ERP) approaches.
- A Systematic Literature Review on the Efficacy of Pharmacological Interventions in Ataxia () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1292;
Limited therapeutic options are available for ataxia, often focusing on symptomatic management rather than addressing the underlying cause. This SLR underscores a notable gap in treatments that directly target ataxia and highlights the potential pharmacological treatments in treating ataxia or slowing its progression.
- | Journal: Pharmacological Treatment of Cognitive Impairment Associated With Schizophrenia: State of the Art and Future Perspectives. (Pubmed Central) - Aug 15, 2024
Some molecules that are currently being investigated in Phase 2 and Phase 3 trials have provided very promising preliminary results, but more information is currently required to assess their effectiveness in real-world contexts and to provide clear recommendations regarding their use in clinical practice. The results of ongoing and future studies will reveal whether any of these molecules represents the awaited pharmacological game-changer in the treatment of CIAS.
- luvadaxistat (NBI-1065844) / Neurocrine, iclepertin (BI425809) / Boehringer Ingelheim, encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
Meta-Analysis of Adjunctive Treatment Trials for Cognitive Deficits in Schizophrenia (Griffin Hall) - Apr 14, 2024 - Abstract #SOBP2024SOBP_413;
Overall effect sizes were similar across MoA, suggesting that significance for NMDAR modulators is presumably driven by the larger number of studies. Nevertheless, effect sizes were generally small, suggesting possible ceiling effects or the need for combined behavioral/pharmacological treatments.
- || luvadaxistat (NBI-1065844) / Neurocrine
Enrollment closed, Trial primary completion date: ERUDITE: Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia (clinicaltrials.gov) - Apr 11, 2024
P2, N=200, Active, not recruiting, Sponsor: Neurocrine Biosciences
Nevertheless, effect sizes were generally small, suggesting possible ceiling effects or the need for combined behavioral/pharmacological treatments. Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2024 --> Jul 2024
- ||| luvadaxistat (NBI-1065844) / Neurocrine
Enrollment change: ERUDITE: Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia (clinicaltrials.gov) - Jul 20, 2023
P2, N=200, Recruiting, Sponsor: Neurocrine Biosciences
Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2024 --> Jul 2024 N=308 --> 200
- || luvadaxistat (NBI-1065844) / Neurocrine, Skyclarys (omaveloxolone) / Reata, Vincerinone (vatiquinone) / Sumitomo Pharma, PTC Therap
Review, Journal: Clinical evidence of interventions assessed in Friedreich ataxia: a systematic review. (Pubmed Central) - May 14, 2023
Other therapeutic interventions were investigated in one publication: A0001, CoQ10, creatine, deferiprone, interferon-?-1b, the L-carnitine levorotatory form of 5-hydroxytryptophan, luvadaxistat, resveratrol, RT001, and vatiquinone (EPI-743)...Identified literature showed a considerable unmet need for therapeutic interventions that halt or slow the deteriorating nature of FA. Novel efficacious drugs should be investigated that aim to improve symptoms or slow disease progression.
- ||||| luvadaxistat (NBI-1065844) / Neurocrine
New P2 trial: Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia Estudio para evaluar la eficacia, la seguridad y la tolerabilidad del Luvadaxistat en pacientes con deterioro cognitivo asociado a la esquizofrenia (EUDRACT) - Feb 21, 2023
P2, N=308, Ongoing, Sponsor: Neurocrine Biosciences, Inc.
- luvadaxistat (NBI-1065844) / Neurocrine
Luvadaxistat, an Investigational D-Amino Acid Oxidase inhibitor, Was Associated with Signals of Efficacy in Cognitive Impairment Associated with Schizophrenia but Not Negative symptoms: Results from the Interact Study (Palomino Ballroom 4-10) - May 6, 2022 - Abstract #ASCP2022ASCP_110;
P2
In line with past clinical experience, luvadaxistat was generally well tolerated. Study funded by Takeda Pharmaceutical Company, Ltd and Neurocrine Biosciences, Inc.
- luvadaxistat (NBI-1065844) / Neurocrine
Luvadaxistat, an Investigational D-Amino Acid Oxidase inhibitor, Was Associated with Signals of Efficacy in Cognitive Impairment Associated with Schizophrenia but Not Negative symptoms: Results from the Interact Study (Salon A-E) - May 6, 2022 - Abstract #ASCP2022ASCP_30;
P2
In line with past clinical experience, luvadaxistat was generally well tolerated. Study funded by Takeda Pharmaceutical Company, Ltd and Neurocrine Biosciences, Inc.
- luvadaxistat (NBI-1065844) / Neurocrine
Regional Comparison of Paired Ratings in a Study of Negative Symptom Schizophrenia () - Mar 11, 2022 - Abstract #SIRS2022SIRS_942;
P2
Bland-Altman scatterplots revealed that 4.8% of paired PANSS scores and 4.7% of paired BNSS scores were outside the confidence intervals. For all pairs, the site-based mean total BNSS and PANSS scores were significantly lower than the paired site-independent scores (p<0.0001 and p= 0.006 respectively).
- luvadaxistat (NBI-1065844) / Neurocrine
Luvadaxistat, an Investigational D-Amino Acid Oxidase inhibitor, Showed Signals of Efficacy in Cognitive Impairment Associated with Schizophrenia but Not Negative symptoms: Results from the Interact Study () - Mar 11, 2022 - Abstract #SIRS2022SIRS_903;
P2
Baseline demographics and characteristics were evenly distributed across treatment groups. No significant improvements in PANSS NSFS versus placebo were observed with luvadaxistat 50 mg, 125 mg or 500 mg at Week 12 (p = 0.426, p = 0.362 and p = 0.808, respectively).
- luvadaxistat (NBI-1065844) / Neurocrine, omaveloxolone (RTA 408) / Reata, Vincerinone (vatiquinone) / Sumitomo Dainippon, PTC Therap
Clinical Efficacy and Safety of Therapeutic Interventions Used in Friedreich Ataxia: A Systematic Review (Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_460;
This SLR highlighted a considerable unmet need for treatments that improve symptoms related to ataxia and neurological symptoms in FA. Currently, novel efficacious drugs are being investigated that aim to improve these symptoms or slow down the progression of the disease.
- || luvadaxistat (NBI-1065844) / Neurocrine
Clinical, Journal: Results of a randomized double-blind study evaluating luvadaxistat in adults with Friedreich ataxia. (Pubmed Central) - Jan 13, 2022
Currently, novel efficacious drugs are being investigated that aim to improve these symptoms or slow down the progression of the disease. Luvadaxistat was safe and well tolerated in this cohort of adults with FRDA; however, it did not demonstrate efficacy as a treatment for this condition.
- ||||| luvadaxistat (NBI-1065844) / Neurocrine
New P2 trial: ERUDITE: Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia (clinicaltrials.gov) - Jan 9, 2022
P2, N=308, Recruiting, Sponsor: Neurocrine Biosciences
- luvadaxistat (NBI-1065844) / Neurocrine
Luvadaxistat, an Investigational D-Amino Acid Oxidase Inhibitor, was Associated With Signals of Efficacy in Cognitive Impairment Associated With Schizophrenia but Not Negative Symptoms: Results From the Interact Study ([VIRTUAL]) - Nov 28, 2021 - Abstract #ACNP2021ACNP_1192;
P2
For CIAS, an inverted U-shaped dose response was observed with luvadaxistat 50 mg, 125 mg and 500mg. Only luvadaxistat 50 mg showed a signal of efficacy as measured by the BACS composite score and the SCoRS interviewer total score, with a clinically meaningful effect size of 0.4 for each.
- luvadaxistat (NBI-1065844) / Neurocrine
Pre-Clinical Evaluation of Hippocampal Long-Term Potentiation After Acute and Sub-Chronic Oral Dosing With Luvadaxistat in Mice ([VIRTUAL]) - Nov 28, 2021 - Abstract #ACNP2021ACNP_1181;
2017). Sub-chronic dosing with luvadaxistat significantly increased LTP suggesting increases in synaptic plasticity.
- luvadaxistat (NBI-1065844) / Neurocrine
Luvadaxistat, a D-Amino Acid Oxidase Inhibitor, Improves Mismatch Negativity in Patients With Schizophrenia ([VIRTUAL]) - Nov 28, 2021 - Abstract #ACNP2021ACNP_1058;
P2
These effects were observed only at the lower dose of 50 mg and not with 500 mg. These results are consistent with the findings of improvement in cognitive performance with 50 mg but not with 500 mg reported in the Phase 2 INTERACT study (see accompanying poster).
- luvadaxistat (NBI-1065844) / Neurocrine
Luvadaxistat, a D-Amino Acid Oxidase Inhibitor, Improves Mismatch Negativity in Patients With Schizophrenia (Exhibit Hall C) - Nov 28, 2021 - Abstract #ACNP2021ACNP_464;
P2
These effects were observed only at the lower dose of 50 mg and not with 500 mg. These results are consistent with the findings of improvement in cognitive performance with 50 mg but not with 500 mg reported in the Phase 2 INTERACT study (see accompanying poster).
- || luvadaxistat (NBI-1065844) / Neurocrine
PK/PD data, Preclinical, Journal: Mechanistic Multilayer Quantitative Model for Nonlinear Pharmacokinetics, Target Occupancy and Pharmacodynamics (PK/TO/PD) Relationship of D-Amino Acid Oxidase Inhibitor, TAK-831 in Mice. (Pubmed Central) - Jun 16, 2021
A quantitative mechanistic model for concentration- and time-dependent nonlinear PK/TO/PD relationship was established for TAK-831 in mice with accounting for possible rate-determining process. The established mechanistic modeling framework will provide a quantitative means for multilayer biomarker-assisted clinical development in multiple central nervous system indications.
- |||| luvadaxistat (NBI-1065844) / Neurocrine
Trial completion, Enrollment change: A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia (clinicaltrials.gov) - Jan 22, 2021
P2, N=307, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
The established mechanistic modeling framework will provide a quantitative means for multilayer biomarker-assisted clinical development in multiple central nervous system indications. Active, not recruiting --> Completed | N=234 --> 307
- || luvadaxistat (NBI-1065844) / Neurocrine
Trial completion: A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia (clinicaltrials.gov) - Jan 19, 2021
P2, N=31, Completed, Sponsor: Takeda
Active, not recruiting --> Completed | N=234 --> 307 Active, not recruiting --> Completed
- ||| luvadaxistat (NBI-1065844) / Neurocrine
Enrollment closed: A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia (clinicaltrials.gov) - Sep 2, 2020
P2, N=234, Active, not recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Journal: Keeping up with the therapeutic advances in schizophrenia: a review of novel and emerging pharmacological entities. (Pubmed Central) - Aug 4, 2020
Most of these trial programs are still ongoing or have yielded mixed or even negative results. Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently.
- || luvadaxistat (NBI-1065844) / Neurocrine
Trial completion date, Trial primary completion date: A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia (clinicaltrials.gov) - Jul 15, 2020
P2, N=234, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently. Trial completion date: Jul 2020 --> Mar 2021 | Trial primary completion date: Jul 2020 --> Mar 2021
- | luvadaxistat (NBI-1065844) / Neurocrine
Trial completion date, Trial primary completion date: A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia (clinicaltrials.gov) - Jul 7, 2020
P2, N=32, Active, not recruiting, Sponsor: Takeda
Trial completion date: Jul 2020 --> Mar 2021 | Trial primary completion date: Jul 2020 --> Mar 2021 Trial completion date: Jun 2020 --> Dec 2020 | Trial primary completion date: Jun 2020 --> Dec 2020
- || luvadaxistat (NBI-1065844) / Neurocrine
Trial completion: A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants (clinicaltrials.gov) - Apr 7, 2020
P1, N=6, Completed, Sponsor: Takeda
Trial completion date: Jun 2020 --> Dec 2020 | Trial primary completion date: Jun 2020 --> Dec 2020 Recruiting --> Completed
- || luvadaxistat (NBI-1065844) / Neurocrine
Enrollment open: A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants (clinicaltrials.gov) - Feb 24, 2020
P1, N=6, Recruiting, Sponsor: Takeda
Recruiting --> Completed Not yet recruiting --> Recruiting
- | luvadaxistat (NBI-1065844) / Neurocrine
Trial completion date, Trial primary completion date: A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia (clinicaltrials.gov) - Feb 6, 2020
P2, N=32, Recruiting, Sponsor: Takeda
Not yet recruiting --> Recruiting Trial completion date: Jan 2020 --> Apr 2020 | Trial primary completion date: Jan 2020 --> Apr 2020
- || luvadaxistat (NBI-1065844) / Neurocrine
New P1 trial: A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants (clinicaltrials.gov) - Jan 21, 2020
P1, N=6, Not yet recruiting, Sponsor: Takeda
- TAK-831 / Takeda
Top-Line Results of a Phase 2, Double-Blind Study to Evaluate Efficacy and Tolerability of TAK-831 in Adults with Friedreich Ataxia (EXHIBIT HALL - A) - Nov 11, 2019 - Abstract #IARC2019IARC_6;
Conclusions Based on the results of this study, we conclude that TAK-831 was safe and well tolerated in FA patients but was not effective as a treatment for this indication. We sincerely appreciate the contributions of the FA patients who enabled us to complete this study in an expeditious manner and reach a clear scientific conclusion.
- TAK-831 / Takeda
Speech, Posture, and Gait Results of a Phase 2, Double-Blind Study to Evaluate TAK-831 in Adults with Friedreich Ataxia (EXHIBIT HALL - A) - Nov 11, 2019 - Abstract #IARC2019IARC_2;
Results Data analysis is ongoing, and further results will be presented. Conclusion The study showed that it is feasible to collect speech and posture/gait data in a multicenter trial of Friedreich ataxia or a similar condition that is treated in specialized centers.
- TAK-831 / Takeda
Exploring the Patient Experience in Friedreich Ataxia (FRDA) through Qualitative Interviews (EXHIBIT HALL - A) - Nov 11, 2019 - Abstract #IARC2019IARC_1;
A majority of the patients reported no improvement in symptoms and functional impacts over the course of the trial which highlights the unmet need among patients. Additionally, no patient reported differences were found between TAK-831 and placebo arms which is consistent with the clinical trial findings.
- || TAK-831 / Takeda
@TakedaOncology What is the latest update for the treatment of Frederick's ataxia (TAK-831) (Twitter) - Sep 25, 2019
- | luvadaxistat (NBI-1065844) / Neurocrine
Trial completion date, Trial primary completion date: A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia (clinicaltrials.gov) - Sep 6, 2019
P2, N=32, Recruiting, Sponsor: Takeda
Additionally, no patient reported differences were found between TAK-831 and placebo arms which is consistent with the clinical trial findings. Trial completion date: Aug 2019 --> Jan 2020 | Trial primary completion date: Aug 2019 --> Jan 2020
- || luvadaxistat (NBI-1065844) / Neurocrine
Trial completion: Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects (clinicaltrials.gov) - Jun 20, 2019
P1, N=40, Completed, Sponsor: Takeda
Trial completion date: Aug 2019 --> Jan 2020 | Trial primary completion date: Aug 2019 --> Jan 2020 Active, not recruiting --> Completed
- || luvadaxistat (NBI-1065844) / Neurocrine
Enrollment open: A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia (clinicaltrials.gov) - Jun 19, 2019
P2, N=32, Recruiting, Sponsor: Takeda
Active, not recruiting --> Completed Active, not recruiting --> Recruiting
- || luvadaxistat (NBI-1065844) / Neurocrine
Enrollment closed: Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects (clinicaltrials.gov) - Jun 11, 2019
P1, N=40, Active, not recruiting, Sponsor: Takeda
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- TAK-831 / Neurocrine
Pre-Clinical Assessment of TAK-831, a Selective D-Amino Acid Oxidase Inhibitor, in Animal Models of Schizophrenia (Regency S-V) - Apr 3, 2019 - Abstract #SIRS2019SIRS_377;
Its efficacy in EBC shows the impact on cerebellar-based learning; this region of the brain is now considered to also be involved in schizophrenia. TAK-831 shows a different range of efficacies pre-clinically, depending on whether the compound is dosed acutely or chronically, indicating a potential plasticity of effect in the brain of preclinical species.
- | luvadaxistat (NBI-1065844) / Neurocrine
Trial completion date, Trial primary completion date: Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects (clinicaltrials.gov) - Mar 25, 2019
P1, N=40, Recruiting, Sponsor: Takeda
TAK-831 shows a different range of efficacies pre-clinically, depending on whether the compound is dosed acutely or chronically, indicating a potential plasticity of effect in the brain of preclinical species. Trial completion date: Feb 2019 --> Jun 2019 | Trial primary completion date: Feb 2019 --> Jun 2019
- ||| luvadaxistat (NBI-1065844) / Neurocrine
Trial completion: Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia (clinicaltrials.gov) - Jan 9, 2019
P2, N=67, Completed, Sponsor: Takeda
Trial completion date: Feb 2019 --> Jun 2019 | Trial primary completion date: Feb 2019 --> Jun 2019 Active, not recruiting --> Completed
- || luvadaxistat (NBI-1065844) / Neurocrine
Trial completion: A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants (clinicaltrials.gov) - Jan 8, 2019
P1, N=16, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Completed Recruiting --> Completed
- | luvadaxistat (NBI-1065844) / Neurocrine
Enrollment open: Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects (clinicaltrials.gov) - Nov 1, 2018
P1, N=40, Recruiting, Sponsor: Takeda
Recruiting --> Completed Not yet recruiting --> Recruiting
- | luvadaxistat (NBI-1065844) / Neurocrine
Enrollment open: A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants (clinicaltrials.gov) - Oct 29, 2018
P1, N=16, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | luvadaxistat (NBI-1065844) / Neurocrine
New P1 trial: A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants (clinicaltrials.gov) - Oct 16, 2018
P1, N=16, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- || luvadaxistat (NBI-1065844) / Neurocrine
Enrollment closed: Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia (clinicaltrials.gov) - Oct 2, 2018
P2, N=67, Active, not recruiting, Sponsor: Takeda
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || luvadaxistat (NBI-1065844) / Neurocrine
New P1 trial: Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects (clinicaltrials.gov) - Sep 26, 2018
P1, N=32, Not yet recruiting, Sponsor: Takeda
- || luvadaxistat (NBI-1065844) / Neurocrine
Trial completion: A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants (clinicaltrials.gov) - Sep 21, 2018
P1, N=50, Completed, Sponsor: Takeda
Recruiting --> Active, not recruiting Recruiting --> Completed
- | luvadaxistat (NBI-1065844) / Neurocrine
Enrollment closed: A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia (clinicaltrials.gov) - Aug 15, 2018
P2, N=32, Active, not recruiting, Sponsor: Takeda
Recruiting --> Completed Recruiting --> Active, not recruiting