Trial · NCT02446132
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64) | Safety population included all participants who received the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious TEAE | From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64) | Safety population included all participants who received the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities | Baseline (current study) up to 52 weeks | Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities | Baseline (current study) up to 52 weeks | Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding | Baseline (current study), Week 52 | Safety population included all participants who received the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Baseline (current study) up to 52 weeks | Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64 | Baseline (current study), Week 64 | Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52 | Baseline (current study), Week 52 | Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52 | Baseline (current study), Week 52 | Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score at Week 64 | Baseline (current study), Week 64 | Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed. | ||
| SECONDARY | Change From Baseline in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) at Week 52 | Baseline (current study), Week 52 | Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed. | ||
| SECONDARY | Change From Baseline in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score at Week 64 | Baseline (current study), Week 64 | Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed. | ||
| SECONDARY | Change From Baseline in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score at Week 52 | Baseline (current study), Week 52 | Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed. | ||
| SECONDARY | Change From Baseline in the Patient Global Impression of Change (PGIC) Score at Week 52 | Baseline (current study), Week 52 | Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed. | ||
| SECONDARY | Change From Baseline in the Dementia Quality of Life (DEMQOL) Score at Week 52 | Baseline (current study), Week 52 | Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed. | ||
| SECONDARY | Change From Baseline in the Resource Utilization in Dementia (RUD) Score at Week 52 | Baseline (current study), Week 52 | Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed. | ||
| SECONDARY | Change From Baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants From Study 17-AVP-786-305 at Week 52 | Baseline (current study), Week 52 | Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed. | ||
| OTHER_PRE_SPECIFIED | Number of Participants Using Concomitant Medications | Baseline (current study) up to 64 weeks |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT02446132/outcomes