Clinical Trials List
Protocol NumberRVT-101-3002
NCT Number(ClinicalTrials.gov Identfier)NCT02586909
Completed
2017-05-01 - 2019-12-31
Phase III
Terminated1
Study ended1
ICD-10G30
Alzheimer's disease
ICD-9331.0
Alzheimer's disease
A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Alzheimer’s Disease
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Trial Applicant
WORLDWIDE CLINICAL TRIALS (TAIWAN) CO., LTD.
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Sponsor
Axovant
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Trial scale
Multi-Regional Multi-Center
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Update
2026/10/13
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Principal Investigator
Chin-Chang Huang
Co-Principal Investigator
- KuoLun Huang Division of Neurology
- Hong-Chou Kuo Division of Neurology
The Actual Total Number of Participants Enrolled
4 Study ended
Audit
None
Condition/Disease
Alzheimer’s Disease
Objectives
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Test Drug
RVT-101
Active Ingredient
RVT-101, a 5-HT6 antagonist, is a nitrogen containing heterocycle also possessing aliphatic amine, a
Dosage Form
Tablet
Dosage
35 mg
Endpoints
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Inclution Criteria
Inclusion Criteria:
Completed last on-treatment visit of the lead-in study RVT-101-3001
Completed last on-treatment visit of the lead-in study RVT-101-3001
Exclusion Criteria
Exclusion Criteria:
Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
The Estimated Number of Participants
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Taiwan
40 participants
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Global
1150 participants
