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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02928445
Other study ID # RVT-101-2002
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received October 7, 2016
Last updated April 17, 2018
Start date October 2016
Est. completion date February 2018

Study information

Verified date February 2018
Source Axovant Sciences Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 240
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years to 86 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RVT-101 35 mg
once daily, oral, 35-mg tablets
RVT-101 70 mg
once daily, oral, 35-mg tablets

Locations

Country Name City State
Canada CA200 Toronto Ontario
France FR957 Lille Nord
France FR959 Paris
France FR960 Paris
France FR953 Saint-Herblain
France FR950 Strasbourg
France FR952 Toulouse Haute-Garonne
France FR955 VandÅ“uvre-lès-Nancy
France FR951 Villeurbanne Rhone
Italy IT302 Brescia Lombardia
Italy IT306 Brescia
Italy IT300 Genova Liguria
Italy IT301 Milano
Italy IT304 Tricase Lecce
Italy IT305 Venice
Netherlands NE402 Amsterdam Noord-Holland
Netherlands NE401 Den Bosch
Spain SP600 Barcelona
Spain SP605 Barcelona
United Kingdom UK807 Bristol
United Kingdom UK801 Cambridge Cambridgeshire
United Kingdom UK806 Dundee
United Kingdom UK808 Epping Essex
United Kingdom UK805 Isleworth
United Kingdom UK800 London
United Kingdom UK809 London
United Kingdom UK802 Manchester
United Kingdom UK803 Newcastle upon Tyne
United Kingdom UK804 Southampton Hampshire
United States US136 Atlanta Georgia
United States US104 Boca Raton Florida
United States US100 Chapel Hill North Carolina
United States US101 Charlottesville Virginia
United States US110 Cleveland Ohio
United States US106 Columbus Ohio
United States US141 Englewood Colorado
United States US118 Indianapolis Indiana
United States US111 Jacksonville Florida
United States US105 Lexington Kentucky
United States US109 New York New York
United States US119 Orange California
United States US122 Orlando Florida
United States US134 Oxnard California
United States US137 Palm Beach Gardens Florida
United States US108 Phoenix Arizona
United States US138 Phoenix Arizona
United States US131 Portland Oregon
United States US130 Quincy Massachusetts
United States US133 Rancho Mirage California
United States US102 Rochester Minnesota
United States US140 Sacramento California
United States US139 Sun City Arizona
United States US126 Tampa Florida
United States US125 Tucson Arizona
United States US123 Washington District of Columbia
United States US120 Willow Grove Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Axovant Sciences Ltd.

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments 24 weeks
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