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
Toronto, Ontario
427
mi
from 02139
Toronto,
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136 Georgia Avenue
Atlanta, Georgia 30331
935
mi
from 02139
Atlanta, GA
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Boca Raton, Florida 33431
1216
mi
from 02139
Boca Raton, FL
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100 Old Mason Farm Road
Chapel Hill, North Carolina 27514
615
mi
from 02139
Chapel Hill, NC
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101 Virginia 6
Charlottesville, Virginia 22908
506
mi
from 02139
Charlottesville, VA
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Cleveland, Ohio 44195
543
mi
from 02139
Cleveland, OH
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Columbus, Ohio 43210
640
mi
from 02139
Columbus, OH
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Englewood, Colorado 80113
1763
mi
from 02139
Englewood, CO
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Indianapolis, Indiana 46202
803
mi
from 02139
Indianapolis, IN
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Jacksonville, Florida 32224
1014
mi
from 02139
Jacksonville, FL
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Lexington, Kentucky 40536
766
mi
from 02139
Lexington, KY
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New York, New York 10032
227
mi
from 02139
New York, NY
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146 South Main Street
Orange, California 92868
2577
mi
from 02139
Orange, CA
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4200 Conroy Road
Orlando, Florida 32806
1119
mi
from 02139
Orlando, FL
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134 California 1
Oxnard, California 93030
2629
mi
from 02139
Oxnard, CA
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Palm Beach Gardens, Florida 33410
1185
mi
from 02139
Palm Beach Gardens, FL
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138 North Arizona Boulevard
Phoenix, Arizona 85006
2280
mi
from 02139
Phoenix, AZ
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Phoenix, Arizona 85013
2291
mi
from 02139
Phoenix, AZ
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1503 North Hayden Island Drive
Portland, Oregon 97210
2529
mi
from 02139
Portland, OR
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130 Massachusetts Avenue
Quincy, Massachusetts 02196
1
mi
from 02139
Quincy, MA
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133 Mirage Cove Drive
Rancho Mirage, California 92270
2506
mi
from 02139
Rancho Mirage, CA
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Rochester, Minnesota 55905
1081
mi
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Rochester, MN
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Sacramento, California 95816
2622
mi
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Sacramento, CA
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Sun City, Arizona 85351
2300
mi
from 02139
Sun City, AZ
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Tampa, Florida 33609
1184
mi
from 02139
Tampa, FL
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Tucson, Arizona 85704
2273
mi
from 02139
Tucson, AZ
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Washington, District of Columbia 20007
393
mi
from 02139
Washington,
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Willow Grove, Pennsylvania 19090
258
mi
from 02139
Willow Grove, PA
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