search
Back to results

Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

Primary Purpose

Dementia With Lewy Bodies

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RVT-101 35 mg
RVT-101 70 mg
Placebo
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, Lewy bodies, intepirdine, RVT-101, dementia

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subject with probable DLB
  • Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
  • Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
  • Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
  • Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion Criteria:

  • Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
  • Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.

Sites / Locations

  • US138
  • US108
  • US139
  • US125
  • US119
  • US134
  • US133
  • US140
  • US141
  • US123
  • US104
  • US116
  • US111
  • US122
  • US137
  • US126
  • US136
  • US112
  • US118
  • US105
  • US135
  • US130
  • US102
  • US109
  • US100
  • US110
  • US106
  • US131
  • US120
  • US124
  • US101
  • CA200
  • CA201
  • FR952
  • FR957
  • FR951
  • FR954
  • FR959
  • FR956
  • FR960
  • FR953
  • FR950
  • FR955
  • IT304
  • IT300
  • IT302
  • IT306
  • IT301
  • IT305
  • NE402
  • NE401
  • NE400
  • SP600
  • SP605
  • SP602
  • UK801
  • UK808
  • UK804
  • UK807
  • UK806
  • UK805
  • UK800
  • UK809
  • UK802
  • UK803

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RVT-101 35 mg

RVT-101 70 mg

Placebo

Arm Description

RVT-101 35 mg once daily

RVT-101 70 mg once daily

Placebo

Outcomes

Primary Outcome Measures

Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.

Secondary Outcome Measures

Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24
The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24
To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.

Full Information

First Posted
January 25, 2016
Last Updated
April 4, 2019
Sponsor
Axovant Sciences Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02669433
Brief Title
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Official Title
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (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 study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
Detailed Description
The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies. The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo). Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).

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, Lewy bodies, intepirdine, RVT-101, dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
484 (Actual)

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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily, oral, matching tablets
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
Description
The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
Time Frame
Change from Baseline at 24 weeks
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24
Description
The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
Time Frame
Change from Baseline at 24 weeks
Title
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24
Description
To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.
Time Frame
Change from Baseline at 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subject with probable DLB Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator Patient has a reliable caregiver who is willing to report on the subject's status throughout the study Patients currently receiving therapy for DLB are eligible for enrollment Exclusion Criteria: Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis. Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient 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
Irvine
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
US116
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
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
US112
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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
US135
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
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
US124
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
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
CA201
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 3H5
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
Rhône
ZIP/Postal Code
69100
Country
France
Facility Name
FR954
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
FR959
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
FR956
City
Paris
ZIP/Postal Code
75013
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
Vandoeuvre les 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
Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
NE400
City
Rotterdam
ZIP/Postal Code
3015 CE
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
SP602
City
Burgos
ZIP/Postal Code
09006
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
TW76FY
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

Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

We'll reach out to this number within 24 hrs