Clinical trial NCT02928445: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Dementia With Lewy Bodies
Keywords: Dementia with Lewy bodies
dementia
RVT-101
intepirdine
Lewy bodies
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
First posted: 2016-10-10
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: US138
state: Arizona
city: Phoenix
country: United States
facility: US108
state: Arizona
city: Sun City
country: United States
facility: US139
state: Arizona
city: Tucson
country: United States
facility: US125
state: Arizona
city: Orange
country: United States
facility: US119
state: California
city: Oxnard
country: United States
facility: US134
state: California
city: Rancho Mirage
country: United States
facility: US133
state: California
city: Sacramento
country: United States
facility: US140
state: California
city: Englewood
country: United States
facility: US141
state: Colorado
city: Washington
country: United States
facility: US123
state: District of Columbia
city: Boca Raton
country: United States
facility: US104
state: Florida
city: Jacksonville
country: United States
facility: US111
state: Florida
city: Orlando
country: United States
facility: US122
state: Florida
city: Palm Beach Gardens
country: United States
facility: US137
state: Florida
city: Tampa
country: United States
facility: US126
state: Florida
city: Atlanta
country: United States
facility: US136
state: Georgia
city: Indianapolis
country: United States
facility: US118
state: Indiana
city: Lexington
country: United States
facility: US105
state: Kentucky
city: Quincy
country: United States
facility: US130
state: Massachusetts
city: Rochester
country: United States
facility: US102
state: Minnesota
city: New York
country: United States
facility: US109
state: New York
city: Chapel Hill
country: United States
facility: US100
state: North Carolina
city: Cleveland
country: United States
facility: US110
state: Ohio
city: Columbus
country: United States
facility: US106
state: Ohio
city: Portland
country: United States
facility: US131
state: Oregon
city: Willow Grove
country: United States
facility: US120
state: Pennsylvania
city: Charlottesville
country: United States
facility: US101
state: Virginia
city: Toronto
country: Canada
facility: CA200
state: Ontario
city: Toulouse
country: France
facility: FR952
state: Haute-Garonne
city: Lille
country: France
facility: FR957
state: Nord
city: Villeurbanne
country: France
facility: FR951
state: Rhone
city: Paris
country: France
facility: FR959
city: Paris
country: France
facility: FR960
city: Saint-Herblain
country: France
facility: FR953
city: Strasbourg
country: France
facility: FR950
city: Vandœuvre-lès-Nancy
country: France
facility: FR955
city: Tricase
country: Italy
facility: IT304
state: Lecce
city: Genova
country: Italy
facility: IT300
state: Liguria
city: Brescia
country: Italy
facility: IT302
state: Lombardia
city: Brescia
country: Italy
facility: IT306
city: Milano
country: Italy
facility: IT301
city: Venice
country: Italy
facility: IT305
city: Amsterdam
country: Netherlands
facility: NE402
state: Noord-Holland
city: Den Bosch
country: Netherlands
facility: NE401
city: Barcelona
country: Spain
facility: SP600
city: Barcelona
country: Spain
facility: SP605
city: Cambridge
country: United Kingdom
facility: UK801
state: Cambridgeshire
city: Epping
country: United Kingdom
facility: UK808
state: Essex
city: Southampton
country: United Kingdom
facility: UK804
state: Hampshire
city: Bristol
country: United Kingdom
facility: UK807
city: Dundee
country: United Kingdom
facility: UK806
city: Isleworth
country: United Kingdom
facility: UK805
city: London
country: United Kingdom
facility: UK800
city: London
country: United Kingdom
facility: UK809
city: Manchester
country: United Kingdom
facility: UK802
city: Newcastle upon Tyne
country: United Kingdom
facility: UK803
Study officials:
affiliation: Axovant Sciences Inc., Senior Vice President, Clinical Research
name: Ilise Lombardo, MD
role: STUDY_DIRECTOR
References: