Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 86
Updated:2/17/2018
Start Date:October 2016
End Date:February 2018

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A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

This 6-month extension study will provide further information regarding the long-term safety
and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB)
who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.

This 6-month, double-blind,extension study will provide further information regarding the
long-term safety and tolerability of intepirdine (RVT-101) in subjects with DLB who have
participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001. The study
duration for subjects in study centers in the USA will be 12 months.

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.

Inclusion Criteria:

- Participated in the lead-in study RVT-101-2001.

Exclusion Criteria:

- Any clinically relevant concomitant disease, which, in the opinion of the
Investigator, makes the subject unsuitable for inclusion in the study.
We found this trial at
28
sites
101 Virginia 6
Charlottesville, Virginia 22908
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136 Georgia Avenue
Atlanta, Georgia 30331
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Atlanta, GA
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Boca Raton, Florida 33431
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Boca Raton, FL
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100 Old Mason Farm Road
Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Cleveland, Ohio 44195
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Cleveland, OH
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Columbus, Ohio 43210
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Columbus, OH
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Englewood, Colorado 80113
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Englewood, CO
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Jacksonville, Florida 32224
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Jacksonville, FL
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Lexington, Kentucky 40536
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Lexington, KY
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New York, New York 10032
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New York, NY
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146 South Main Street
Orange, California 92868
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Orange, CA
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4200 Conroy Road
Orlando, Florida 32806
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Orlando, FL
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134 California 1
Oxnard, California 93030
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Oxnard, CA
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Palm Beach Gardens, Florida 33410
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Palm Beach Gardens, FL
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138 North Arizona Boulevard
Phoenix, Arizona 85006
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Phoenix, AZ
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Phoenix, Arizona 85013
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Phoenix, AZ
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1503 North Hayden Island Drive
Portland, Oregon 97210
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Portland, OR
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130 Massachusetts Avenue
Quincy, Massachusetts 02196
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Quincy, MA
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133 Mirage Cove Drive
Rancho Mirage, California 92270
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Rancho Mirage, CA
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Rochester, Minnesota 55905
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Rochester, MN
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Sacramento, California 95816
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Sun City, Arizona 85351
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Sun City, AZ
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Tampa, Florida 33609
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Tampa, FL
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Toronto, Ontario
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Toronto,
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Tucson, Arizona 85704
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Washington, District of Columbia 20007
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Willow Grove, Pennsylvania 19090
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Willow Grove, PA
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