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
Phoenix, Arizona 85013
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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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101 Virginia 6
Charlottesville, Virginia 22908
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Charlottesville, VA
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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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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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Sacramento, CA
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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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Tucson, AZ
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Washington, District of Columbia 20007
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Washington,
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Willow Grove, Pennsylvania 19090
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Willow Grove, PA
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