Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
NCT ID: NCT02669433
Last Updated: 2019-04-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
484 participants
INTERVENTIONAL
2016-01-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension
NCT02928445
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
NCT02910102
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
NCT02585934
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
NCT02586909
Study to Evaluate the Safety, Tolerability and Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
NCT05225415
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).
Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RVT-101 35 mg
RVT-101 35 mg once daily
RVT-101 35 mg
once daily, oral, 35-mg tablets
RVT-101 70 mg
RVT-101 70 mg once daily
RVT-101 70 mg
once daily, oral, 35-mg tablets
Placebo
Placebo
Placebo
once daily, oral, matching tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RVT-101 35 mg
once daily, oral, 35-mg tablets
RVT-101 70 mg
once daily, oral, 35-mg tablets
Placebo
once daily, oral, matching tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
* Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
* Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
* Patients currently receiving therapy for DLB are eligible for enrollment
Exclusion Criteria
* Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.
50 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Axovant Sciences Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ilise Lombardo, MD
Role: STUDY_DIRECTOR
Axovant Sciences Inc., Senior Vice President, Clinical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
US138
Phoenix, Arizona, United States
US108
Phoenix, Arizona, United States
US139
Sun City, Arizona, United States
US125
Tucson, Arizona, United States
US119
Irvine, California, United States
US134
Oxnard, California, United States
US133
Rancho Mirage, California, United States
US140
Sacramento, California, United States
US141
Englewood, Colorado, United States
US123
Washington D.C., District of Columbia, United States
US104
Boca Raton, Florida, United States
US116
Boca Raton, Florida, United States
US111
Jacksonville, Florida, United States
US122
Orlando, Florida, United States
US137
Palm Beach Gardens, Florida, United States
US126
Tampa, Florida, United States
US136
Atlanta, Georgia, United States
US112
Chicago, Illinois, United States
US118
Indianapolis, Indiana, United States
US105
Lexington, Kentucky, United States
US135
Newton, Massachusetts, United States
US130
Quincy, Massachusetts, United States
US102
Rochester, Minnesota, United States
US109
New York, New York, United States
US100
Chapel Hill, North Carolina, United States
US110
Cleveland, Ohio, United States
US106
Columbus, Ohio, United States
US131
Portland, Oregon, United States
US120
Willow Grove, Pennsylvania, United States
US124
Dallas, Texas, United States
US101
Charlottesville, Virginia, United States
CA200
Toronto, Ontario, Canada
CA201
Sherbrooke, Quebec, Canada
FR952
Toulouse, Haute-Garonne, France
FR957
Lille, Nord, France
FR951
Villeurbanne, Rhône, France
FR954
Bron, , France
FR959
Paris, , France
FR956
Paris, , France
FR960
Paris, , France
FR953
Saint-Herblain, , France
FR950
Strasbourg, , France
FR955
Vandœuvre-lès-Nancy, , France
IT304
Tricase, Lecce, Italy
IT300
Genoa, Liguria, Italy
IT302
Brescia, Lombardy, Italy
IT306
Brescia, , Italy
IT301
Milan, , Italy
IT305
Venice, , Italy
NE402
Amsterdam, North Holland, Netherlands
NE401
's-Hertogenbosch, , Netherlands
NE400
Rotterdam, , Netherlands
SP600
Barcelona, , Spain
SP605
Barcelona, , Spain
SP602
Burgos, , Spain
UK801
Cambridge, Cambridgeshire, United Kingdom
UK808
Epping, Essex, United Kingdom
UK804
Southampton, Hampshire, United Kingdom
UK807
Bristol, , United Kingdom
UK806
Dundee, , United Kingdom
UK805
Isleworth, , United Kingdom
UK800
London, , United Kingdom
UK809
London, , United Kingdom
UK802
Manchester, , United Kingdom
UK803
Newcastle upon Tyne, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RVT-101-2001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.