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

Primary Purpose

Dementia With Lewy Bodies

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RVT-101 35 mg
RVT-101 70 mg
Sponsored by
Axovant Sciences Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia With Lewy Bodies focused on measuring Dementia with Lewy bodies, dementia, RVT-101, intepirdine, Lewy bodies

Eligibility Criteria

50 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • US138
  • US108
  • US139
  • US125
  • US119
  • US134
  • US133
  • US140
  • US141
  • US123
  • US104
  • US111
  • US122
  • US137
  • US126
  • US136
  • US118
  • US105
  • US130
  • US102
  • US109
  • US100
  • US110
  • US106
  • US131
  • US120
  • US101
  • CA200
  • FR952
  • FR957
  • FR951
  • FR959
  • FR960
  • FR953
  • FR950
  • FR955
  • IT304
  • IT300
  • IT302
  • IT306
  • IT301
  • IT305
  • NE402
  • NE401
  • SP600
  • SP605
  • UK801
  • UK808
  • UK804
  • UK807
  • UK806
  • UK805
  • UK800
  • UK809
  • UK802
  • UK803

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RVT-101 35 mg

RVT-101 70 mg

Arm Description

RVT-101 35 mg once daily

RVT-101 70 mg once daily

Outcomes

Primary Outcome Measures

Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments

Secondary Outcome Measures

Full Information

First Posted
October 7, 2016
Last Updated
April 17, 2018
Sponsor
Axovant Sciences Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02928445
Brief Title
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension
Official Title
A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Intepirdine did not meet its primary efficacy endpoints in the lead-in study RVT-101-2001.
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axovant Sciences Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies
Keywords
Dementia with Lewy bodies, dementia, RVT-101, intepirdine, Lewy bodies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RVT-101 35 mg
Arm Type
Experimental
Arm Description
RVT-101 35 mg once daily
Arm Title
RVT-101 70 mg
Arm Type
Experimental
Arm Description
RVT-101 70 mg once daily
Intervention Type
Drug
Intervention Name(s)
RVT-101 35 mg
Intervention Description
once daily, oral, 35-mg tablets
Intervention Type
Drug
Intervention Name(s)
RVT-101 70 mg
Intervention Description
once daily, oral, 35-mg tablets
Primary Outcome Measure Information:
Title
Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilise Lombardo, MD
Organizational Affiliation
Axovant Sciences Inc., Senior Vice President, Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
US138
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
US108
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
US139
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
US125
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
US119
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
US134
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
US133
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
US140
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
US141
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
US123
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
US104
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
US111
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
US122
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
US137
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
US126
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
US136
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
US118
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
US105
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
US130
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02196
Country
United States
Facility Name
US102
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
US109
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
US100
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
US110
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
US106
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
US131
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
US120
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
US101
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
CA200
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
FR952
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31052
Country
France
Facility Name
FR957
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
FR951
City
Villeurbanne
State/Province
Rhone
ZIP/Postal Code
69100
Country
France
Facility Name
FR959
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
FR960
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
FR953
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
FR950
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
FR955
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
IT304
City
Tricase
State/Province
Lecce
ZIP/Postal Code
73039
Country
Italy
Facility Name
IT300
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
IT302
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Facility Name
IT306
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
IT301
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IT305
City
Venice
ZIP/Postal Code
I-30126
Country
Italy
Facility Name
NE402
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
NE401
City
Den Bosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
SP600
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
SP605
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
UK801
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB21 5EF
Country
United Kingdom
Facility Name
UK808
City
Epping
State/Province
Essex
ZIP/Postal Code
CM16 6TN
Country
United Kingdom
Facility Name
UK804
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
Facility Name
UK807
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
UK806
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
UK805
City
Isleworth
ZIP/Postal Code
TW7 6FY
Country
United Kingdom
Facility Name
UK800
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Name
UK809
City
London
ZIP/Postal Code
W1G 9RU
Country
United Kingdom
Facility Name
UK802
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
UK803
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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