Trial · NCT03095066
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
NCT03095066, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2025-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury. Trials, record NCT03095066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03095066
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
- NCT number
- NCT03095066
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 168 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Neurobehavioral Disinhibition
- Interventions
- Placebo, AVP-786-28, AVP-786-42.63
- First posted
- 2017-03-29
- Last updated
- 2025-10-29
- Results first posted
- 2025-10-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscale of Aggression, Agitation, and Irritability/Lability (NPI-C-3) | Baseline to Week 6 | NPI-C is a retrospective informant/caregiver interview covering 12 neuropsychiatric symptom domains. These are collectively rated first by the informant/caregiver based on frequency (0-4);severity (0-3);informant/caregiver distress (0-5) \& then by the participant based on frequency (0-4), which the clinician then integrates into a (0-3) clinical impression severity rating. NPI-C-3= aggression, agitation, \& irritability/lability subscales. NPI-C agitation domain= sum of clinical impression severity scores for agitation questions 1-13 (score=0-39). NPI-C aggression domain= sum of clinician impression severity scores for aggression questions 1-8 (score=0-24). NPI-C irritability/lability domain= sum of clinician impression severity scores for irritability/lability questions 1-12 (score=0-36). NPI-C-3 composite score ranges from 0-99. Higher score= increased severity. Least square (LS) mean was analyzed using mixed effects model repeated measures (MMRM) analysis. |
| Primary | Stage 2: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the NPI-C Subscale of NPI-C-3 | Week 7 to Week 12 | NPI-C is a retrospective informant/caregiver interview covering 12 neuropsychiatric symptom domains. These domains are collectively rated by the informant/caregiver based on frequency (0-4), severity (0-3) \& informant/caregiver distress (0-5), then by participant based on frequency (0-4), which is integrated by clinician into (0-3) clinical impression severity rating. NPI-C-3=aggression, agitation, \& irritability/lability subscales. NPI-C agitation domain=sum of clinical impression severity scores for agitation questions 1-13 (score=0-39). NPI-C aggression domain=sum of clinician impression severity scores for aggression questions 1-8 (score=0-24). NPI-C irritability/lability domain=sum of clinician impression severity scores for irritability/lability questions 1-12 (score= 0-36). NPI-C-3 composite score ranges from 0-99. Higher score=increased severity. LS mean was analyzed using MMRM analysis. Overall number analyzed=number of participants with data available for analysis. |
| Secondary | Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Aggression | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | The NPI-C was used to rate the presence of neuropsychiatric symptoms across 12 domains. The 12 domains are collectively rated first by the informant/caregiver based on frequency (0-4), severity (0-3) \& informant/caregiver distress (0-5), then by the participant based on frequency (0-4), which the clinician then integrates into a (0-3) clinical impression severity rating. The NPI-C aggression domain score is the sum of clinician impression severity scores for aggression questions 1-8, score ranges from 0-24, where higher score indicates greater clinical severity of symptom. LS mean was analyzed using MMRM analysis. Overall number analyzed= number of participants with data available for analysis. Number analyzed= number of participants with data available for analysis at the specified time point. |
| Secondary | Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Agitation | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | The NPI-C is used to rate the presence of neuropsychiatric symptoms across 12 domains. The 12 domains are collectively rated first by the informant/caregiver based on frequency (0-4), severity (0-3) \& informant/caregiver distress (0-5), then by the participant based on frequency (0 to 4), which the clinician then integrates into a (0-3) clinical impression severity rating. The NPI-C agitation domain score is the sum of clinician impression severity scores for agitation questions 1-13, score ranges from 0-39, where higher score indicates greater clinical severity of symptom. LS mean was analyzed using MMRM analysis. Overall number analyzed=number of participants with data available for analysis. Number analyzed=number of participants with data available for analysis at the specified time point. |
| Secondary | Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Irritability/Lability | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | NPI-C is used to rate the presence of neuropsychiatric symptoms across 12 domains. The 12 domains are collectively rated first by the informant/caregiver based on frequency (0-4), severity (0-3) \& informant/caregiver distress (0-5), then by the participant based on frequency (0 to 4), which the clinician then integrates into a (0-3) clinical impression severity rating. NPI-C irritability/lability domain score=sum of clinician impression severity scores for irritability/lability questions 1-12, score ranges from 0-36, where higher score indicates greater clinical severity of symptom. LS mean was analyzed using MMRM analysis. Overall number analyzed=number of participants with data available for analysis. Number analyzed=number of participants with data available for analysis at the specified time point. |
| Secondary | Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Disinhibition | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | The NPI-C is used to rate the presence of neuropsychiatric symptoms across 12 domains. The 12 domains are collectively rated first by the informant/caregiver based on frequency (0-4), severity (0-3) \& informant/caregiver distress (0-5), then by the participant based on frequency (0-4), which the clinician then integrates into a (0-3) clinical impression severity rating. The NPI-C disinhibition domain score is the sum of clinical impression severity scores for disinhibition questions 1-16, score ranges from 0-48, where higher score indicates greater clinical severity of symptom. LS mean was analyzed using MMRM analysis. Overall number analyzed=number of participants with data available for analysis. Number analyzed=number of participants with data available for analysis at the specified time point. |
| Secondary | Stage 1 and Stage 2: Change From Baseline in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | mCGI-S is 7-point (1-7) scale requiring clinician to rate severity of participant's neurobehavioral disinhibition including aggression, agitation and irritability after NPI-C interview, at time of assessment relative to clinician's past experience with participants having same diagnosis. Considering total clinical experience, participant is assessed on severity of illness at time of rating as:0: not assessed;1: normal, not at all ill;2: borderline ill;3: mildly ill;4: moderately ill;5: markedly ill;6: severely ill;7: among most extremely ill participants. Higher score=increased severity. Negative change from baseline=improvement.LS mean was analyzed using analysis of covariance (ANCOVA) model. Overall number analyzed=participants with data available for analysis. Number analyzed=participants with data available for analysis at specified time point. |
| Secondary | Stage 1 and Stage 2: Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | The PGI-S is a single-question scale used to assess the severity of symptoms of neurobehavioral disinhibition including aggression, agitation, and irritability, on a 7-point scale, as 1: normal, not at all ill; 2: borderline ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; or 7: extremely ill. A higher score indicates worsening of the symptoms. Negative change from baseline indicates improvement. LS mean was analyzed using ANCOVA model. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. |
| Secondary | Stage 1 and Stage 2: Modified Clinical Global Impression of Change (mCGI-C) Raw Scores | Stage 1: Week 6; Stage 2: Week 12 | The mGCI-C is a scale that requires the clinician to rate the change of the participant's neurobehavioral disinhibition including aggression, agitation, and irritability at the time of assessment after the NPI-C interview, relative to the clinician's past experience with the participant's neurobehavioral disinhibition at admission. Considering total clinical experience, a participant is assessed for change of mental illness as: 0: not assessed; 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; 7: very much worse. A higher score represents worsening of symptoms. Negative change from baseline indicates improvement. |
| Secondary | Stage 1 and Stage 2: Patient Global Impression of Change (PGI-C) Raw Scores | Stage 1: Week 6; Stage 2: Week 12 | The PGI-C is a 7-point (1-7) scale used to assess treatment response, and it is rated as: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; 7: very much worse. A higher score indicates worsening of the symptoms. Negative change from baseline indicates improvement. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stage 1: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscale of Aggression, Agitation, and Irritability/Lability (NPI-C-3) | Baseline to Week 6 | Modified intent-to-treat (mITT) population. Stage 1: Participants randomized in Stage 1 who took at least 1 dose of study medication \& had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1. Overall number analyzed=participants with data available for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Stage 2: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the NPI-C Subscale of NPI-C-3 | Week 7 to Week 12 | mITT population. Stage 2: participants randomized into Stage 2 with at least 1 NPI-C-3 efficacy assessment in Stage 2. As pre-specified in protocol, data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Aggression | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | mITT population. Stage 1:all participants randomized in Stage 1 who took at least 1 dose of study medication \&had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1; Stage 2:participants randomized into Stage 2 \&had at least 1 NPI-C-3 efficacy assessment in Stage 2(after Week 6). As pre-specified in protocol data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Agitation | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | mITT population. Stage 1:all participants randomized in Stage 1 who took at least 1 dose of study medication \&had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1; Stage 2:participants randomized into Stage 2 \&had at least 1 NPI-C-3 efficacy assessment in Stage 2(after Week 6). As pre-specified in protocol data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Irritability/Lability | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | mITT population. Stage 1:all participants randomized in Stage 1 who took at least 1 dose of study medication \&had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1; Stage 2:participants randomized into Stage 2 \&had at least 1 NPI-C-3 efficacy assessment in Stage 2(after Week 6). As pre-specified in protocol data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Disinhibition | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | mITT population. Stage 1:all participants randomized in Stage 1 who took at least 1 dose of study medication \&had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1; Stage 2:participants randomized into Stage 2 \&had at least 1 NPI-C-3 efficacy assessment in Stage 2(after Week 6). As pre-specified in protocol data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Stage 1 and Stage 2: Change From Baseline in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | mITT population. Stage 1:all participants randomized in Stage 1 who took at least 1 dose of study medication \&had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1; Stage 2:participants randomized into Stage 2 \&had at least 1 NPI-C-3 efficacy assessment in Stage 2(after Week 6). As pre-specified in protocol data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Stage 1 and Stage 2: Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores | Stage 1: Baseline to Week 6; Stage 2: Week 7 to Week 12 | mITT population. Stage 1:all participants randomized in Stage 1 who took at least 1 dose of study medication \&had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1; Stage 2:participants randomized into Stage 2 \&had at least 1 NPI-C-3 efficacy assessment in Stage 2(after Week 6). As pre-specified in protocol data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Stage 1 and Stage 2: Modified Clinical Global Impression of Change (mCGI-C) Raw Scores | Stage 1: Week 6; Stage 2: Week 12 | mITT population. Stage 1:all participants randomized in Stage 1 who took at least 1 dose of study medication \&had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1; Stage 2:participants randomized into Stage 2 \&had at least 1 NPI-C-3 efficacy assessment in Stage 2(after Week 6). As pre-specified in protocol data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | MEAN |
| SECONDARY | Stage 1 and Stage 2: Patient Global Impression of Change (PGI-C) Raw Scores | Stage 1: Week 6; Stage 2: Week 12 | mITT population. Stage 1:all participants randomized in Stage 1 who took at least 1 dose of study medication \&had at least 1 post-baseline NPI-C-3 composite score efficacy assessment in Stage 1; Stage 2:participants randomized into Stage 2 \&had at least 1 NPI-C-3 efficacy assessment in Stage 2(after Week 6). As pre-specified in protocol data for placebo non-responders re-randomized into Stage 2 was used to estimate \& report Stage 2 efficacy. Hence only these Stage 2 arms are reported for the OM. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Stage 1: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscale of Aggression, Agitation, and Irritability/Lability (NPI-C-3) | Stage 1: Placebo | -18.7 | Standard Error 1.74 | score on a scale | |
Stage 1: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscale of Aggression, Agitation, and Irritability/Lability (NPI-C-3) | Stage 1: AVP-786 | -20.4 | Standard Error 1.73 | score on a scale | |
| Stage 2: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the NPI-C Subscale of NPI-C-3 | Stage 1: Placebo Non-responders to Stage 2: Placebo | -5.2 | Standard Error 4.97 | score on a scale | |
| Stage 2: Change From Baseline in the Composite of the Clinical Impression Severity Scores on the NPI-C Subscale of NPI-C-3 | Stage 1: Placebo Non-responders to Stage 2: AVP-786 | -5.9 | Standard Error 5.28 | score on a scale | |
| Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Aggression | Stage 1: Placebo | Change from Baseline to Week 6 | -3.6 | Standard Error 0.40 | score on a scale |
| Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Aggression | Stage 1: AVP-786 | Change from Baseline to Week 6 | -4.3 | Standard Error 0.40 | score on a scale |
| Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Aggression | Stage 1: Placebo Non-responders; to Stage 2: Placebo | Change from Week 7 to Week 12 | -0.8 | Standard Error 1.39 | score on a scale |
| Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Aggression | Stage 1: Placebo Non-responders to Stage 2: AVP-786 | Change from Week 7 to Week 12 | -0.6 | Standard Error 1.55 | score on a scale |
| Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Agitation | Stage 1: Placebo | Change from Baseline to Week 6 | -7.0 | Standard Error 0.69 | score on a scale |
| Stage 1 and Stage 2: Change From Baseline in NPI-C Rating Scale Subscale Scores for Agitation | Stage 1: AVP-786 | Change from Baseline to Week 6 | -6.7 | Standard Error 0.67 | score on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study (Baseline to Week 12) | STARTED | Overall Study: Stage 1 Placebo/Stage 2 Placebo or Stage 1 Placebo/Stage 2 AVP-786 | 83 | |
| Overall Study (Baseline to Week 12) | STARTED | Overall Study: Stage 1 AVP-786/Stage 2 AVP-786 | 85 | |
| Overall Study (Baseline to Week 12) | STARTED | Stage 1: Placebo | 0 | |
| Overall Study (Baseline to Week 12) | STARTED | Stage 1: Placebo Non-responders to Stage 2: Placebo | 0 | |
| Overall Study (Baseline to Week 12) | STARTED | Stage 1: Placebo Non-responders to Stage 2: AVP-786 | 0 | |
| Overall Study (Baseline to Week 12) | STARTED | Stage 1: Placebo Responders to Stage 2: Placebo | 0 | |
| Overall Study (Baseline to Week 12) | STARTED | Stage 1: Placebo Responders to Stage 2: AVP-786 | 0 | |
| Overall Study (Baseline to Week 12) | STARTED | Stage 1 and 2: AVP-786 | 0 | |
| Overall Study (Baseline to Week 12) | COMPLETED | Overall Study: Stage 1 Placebo/Stage 2 Placebo or Stage 1 Placebo/Stage 2 AVP-786 | 58 | |
| Overall Study (Baseline to Week 12) | COMPLETED | Overall Study: Stage 1 AVP-786/Stage 2 AVP-786 | 68 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | All Placebo | 4 | 83 | |
| other | Dizziness | Nervous system disorders | All AVP-786 | 7 | 115 | |
| serious | Cholecystitis acute | Hepatobiliary disorders | All Placebo | 0 | 83 | |
| serious | Cholecystitis acute | Hepatobiliary disorders | All AVP-786 | 1 | 115 | |
| serious | Enterobacter sepsis | Infections and infestations | All Placebo | 0 | 83 | |
| serious | Enterobacter sepsis | Infections and infestations | All AVP-786 | 1 | 115 | |
| serious | Seizure | Nervous system disorders | All Placebo | 0 | 83 | |
| serious | Seizure | Nervous system disorders | All AVP-786 | 1 | 115 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Placebo | 0 | 83 |
| Total, all-cause mortality | All AVP-786 | 0 | 115 |
| Total, other adverse events | All Placebo | 4 | 83 |
| Total, other adverse events | All AVP-786 | 7 | 115 |
| Total, serious adverse events | All Placebo | 0 | 83 |
| Total, serious adverse events | All AVP-786 | 3 | 115 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| All AVP-786 vs All Placebo: deaths from any cause | Trial comparisons |
| All AVP-786 vs All Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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