Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension
NCT ID: NCT02928445
Last Updated: 2018-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
240 participants
INTERVENTIONAL
2016-10-31
2018-02-28
Brief Summary
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Detailed Description
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Subjects who were randomized to the RVT-101 35-mg and RVT-101 70-mg treatment groups in lead-in study RVT-101-2001 will remain in the same treatment groups for this study; subjects who were randomized to the placebo treatment group in the lead-in study will be assigned to the RVT-101 70-mg treatment group in this study.
Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Interventions
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RVT-101 35 mg
once daily, oral, 35-mg tablets
RVT-101 70 mg
once daily, oral, 35-mg tablets
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
86 Years
ALL
No
Sponsors
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Axovant Sciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ilise Lombardo, MD
Role: STUDY_DIRECTOR
Axovant Sciences Inc., Senior Vice President, Clinical Research
Locations
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US138
Phoenix, Arizona, United States
US108
Phoenix, Arizona, United States
US139
Sun City, Arizona, United States
US125
Tucson, Arizona, United States
US119
Orange, 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
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
US118
Indianapolis, Indiana, United States
US105
Lexington, Kentucky, 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
US101
Charlottesville, Virginia, United States
CA200
Toronto, Ontario, Canada
FR952
Toulouse, Haute-Garonne, France
FR957
Lille, Nord, France
FR951
Villeurbanne, Rhone, France
FR959
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
SP600
Barcelona, , Spain
SP605
Barcelona, , 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
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Other Identifiers
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RVT-101-2002
Identifier Type: -
Identifier Source: org_study_id
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