Study Stopped
Intepirdine did not meet its primary efficacy endpoints in the lead-in study RVT-101-2001.
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension
A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
1 other identifier
interventional
240
7 countries
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
Shorter than P25 for phase_2
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedApril 18, 2018
February 1, 2018
1.3 years
October 7, 2016
April 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments
24 weeks
Study Arms (2)
RVT-101 35 mg
EXPERIMENTALRVT-101 35 mg once daily
RVT-101 70 mg
EXPERIMENTALRVT-101 70 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- Participated in the lead-in study RVT-101-2001.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
US138
Phoenix, Arizona, 85006, United States
US108
Phoenix, Arizona, 85013, United States
US139
Sun City, Arizona, 85351, United States
US125
Tucson, Arizona, 85704, United States
US119
Orange, California, 92868, United States
US134
Oxnard, California, 93030, United States
US133
Rancho Mirage, California, 92270, United States
US140
Sacramento, California, 95816, United States
US141
Englewood, Colorado, 80113, United States
US123
Washington D.C., District of Columbia, 20007, United States
US104
Boca Raton, Florida, 33431, United States
US111
Jacksonville, Florida, 32224, United States
US122
Orlando, Florida, 32806, United States
US137
Palm Beach Gardens, Florida, 33410, United States
US126
Tampa, Florida, 33609, United States
US136
Atlanta, Georgia, 30331, United States
US118
Indianapolis, Indiana, 46202, United States
US105
Lexington, Kentucky, 40536, United States
US130
Quincy, Massachusetts, 02196, United States
US102
Rochester, Minnesota, 55905, United States
US109
New York, New York, 10032, United States
US100
Chapel Hill, North Carolina, 27514, United States
US110
Cleveland, Ohio, 44195, United States
US106
Columbus, Ohio, 43210, United States
US131
Portland, Oregon, 97210, United States
US120
Willow Grove, Pennsylvania, 19090, United States
US101
Charlottesville, Virginia, 22908, United States
CA200
Toronto, Ontario, M4N 3M5, Canada
FR952
Toulouse, Haute-Garonne, 31052, France
FR957
Lille, Nord, 59037, France
FR951
Villeurbanne, Rhone, 69100, France
FR959
Paris, 75010, France
FR960
Paris, 75013, France
FR953
Saint-Herblain, 44800, France
FR950
Strasbourg, 67000, France
FR955
Vandœuvre-lès-Nancy, 54500, France
IT304
Tricase, Lecce, 73039, Italy
IT300
Genoa, Liguria, 16132, Italy
IT302
Brescia, Lombardy, 25125, Italy
IT306
Brescia, 25123, Italy
IT301
Milan, 20133, Italy
IT305
Venice, I-30126, Italy
NE402
Amsterdam, North Holland, 1081 HV, Netherlands
NE401
's-Hertogenbosch, 5223 GZ, Netherlands
SP600
Barcelona, 08028, Spain
SP605
Barcelona, 08041, Spain
UK801
Cambridge, Cambridgeshire, CB21 5EF, United Kingdom
UK808
Epping, Essex, CM16 6TN, United Kingdom
UK804
Southampton, Hampshire, SO30 3JB, United Kingdom
UK807
Bristol, BS10 5NB, United Kingdom
UK806
Dundee, DD1 9SY, United Kingdom
UK805
Isleworth, TW7 6FY, United Kingdom
UK800
London, SE5 8AF, United Kingdom
UK809
London, W1G 9RU, United Kingdom
UK802
Manchester, M8 5RB, United Kingdom
UK803
Newcastle upon Tyne, NE4 5PL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ilise Lombardo, MD
Axovant Sciences Inc., Senior Vice President, Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 10, 2016
Study Start
October 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
April 18, 2018
Record last verified: 2018-02