Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation i… (NCT02446132) | Clinical Trial Compass
TerminatedPhase 3
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Stopped: The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.
United States1,197 participantsStarted 2015-11-13
Plain-language summary
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
Who can participate
Age range50 Years – 90 Years
SexALL
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Inclusion Criteria:
* Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
* Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
* Either out-patients or residents of an assisted-living facility or a skilled nursing home
* Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
* Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
* Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
* Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline
Exclusion Criteria:
* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable val…
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
2
Number of Participants With Serious TEAE
Timeframe: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
3
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Timeframe: Baseline (current study) up to 52 weeks
4
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
Timeframe: Baseline (current study) up to 52 weeks
5
Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding
Timeframe: Baseline (current study), Week 52
6
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Timeframe: Baseline (current study) up to 52 weeks
7
Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64
Trial details
NCT IDNCT02446132
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.