Alzheimer's Disease Clinical Trial
Official title:
A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease
| Verified date | March 2018 |
| Source | Axovant Sciences Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).
| Status | Terminated |
| Enrollment | 1099 |
| Est. completion date | March 12, 2018 |
| Est. primary completion date | March 12, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 86 Years |
| Eligibility |
Inclusion Criteria: - Completed last on-treatment visit of the lead-in study RVT-101-3001 Exclusion Criteria: - Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | AR060 | Buenos Aires | |
| Argentina | AR101 | Buenos Aires | |
| Argentina | AR012 | Ciudad Autonoma de Buenos Aire | |
| Argentina | AR027 | Ciudad Autonoma de Buenos Aire | |
| Argentina | AR028 | Ciudad Autonoma de Buenos Aire | |
| Argentina | AR035 | Ciudad Autonoma de Buenos Aire | |
| Argentina | AR084 | Ciudad Autonoma de Buenos Aire | |
| Argentina | AR160 | Ciudad Autonoma de Buenos Aire | |
| Argentina | AR040 | Ciudad Autónoma de Buenos Aire | |
| Argentina | AR081 | Ciudad Autónoma de Buenos Aire | |
| Argentina | AR051 | Córdoba | |
| Argentina | AR126 | Córdoba | |
| Argentina | AR137 | Córdoba | |
| Argentina | AR130 | La Plata | Buenos Aires |
| Argentina | AR210 | Mendoza | |
| Argentina | AR219 | Mendoza | |
| Argentina | AR059 | Santiago del Estero | |
| Australia | AU227 | Caulfield | |
| Australia | AU032 | Heidelberg West | |
| Australia | AU011 | Hornsby | |
| Australia | AU138 | West Perth | |
| Bulgaria | BU125 | Ruse | |
| Bulgaria | BU131 | Sofia | |
| Bulgaria | BU073 | Varna | |
| Canada | CA236 | Gatineau | Quebec |
| Canada | CA054 | Kelowna | British Columbia |
| Canada | CA188 | Kelowna | British Columbia |
| Canada | CA147 | Newmarket | Ontario |
| Canada | CA196 | North York | Ontario |
| Canada | CA186 | Penticton | British Columbia |
| Canada | CA141 | West Vancouver | British Columbia |
| Chile | CH212 | Antofagasta | II Región |
| Chile | CH061 | Santiago | Región Metropolitana |
| Chile | CH075 | Santiago | Región Metropolitana |
| Chile | CH076 | Santiago | Region Metropolitana |
| Croatia | CR069 | Zagreb | |
| Croatia | CR070 | Zagreb | |
| Croatia | CR122 | Zagreb | |
| Czechia | CZE207 | Praha | |
| Czechia | CZE128 | Praha 10 | |
| Czechia | CZE132 | Praha 2 | |
| Czechia | CZE129 | Praha 6 | |
| Czechia | CZE161 | Rychnov nad Kneznou | |
| France | FR231 | Lille Cedex | |
| France | FR182 | Marseille Cedex 5 | |
| France | FR221 | Paris Cedex | |
| France | FR202 | Villeurbanne | |
| Germany | GE206 | Bad Homburg | |
| Germany | GE071 | Berlin | |
| Germany | GE091 | Berlin | |
| Germany | GE139 | Berlin | |
| Germany | GE230 | Cologne | |
| Germany | GE252 | Ellwangen | |
| Germany | GE180 | Leipzig | |
| Germany | GE228 | Mannheim | |
| Germany | GE017 | Munchen | |
| Germany | GE157 | Nürnberg | |
| Germany | GE098 | Ulm | |
| Germany | GE251 | Westerstede | |
| Italy | IT053 | Brescia | |
| Italy | IT124 | Cefalu | |
| Italy | IT030 | Pavia | |
| Italy | IT103 | Perugia | |
| Italy | IT029 | Roma | |
| Italy | IT072 | Roma | |
| Italy | IT175 | Rome | |
| Italy | IT183 | Rome | |
| Italy | IT085 | Torino | |
| Korea, Republic of | SK066 | Busan | |
| Korea, Republic of | SK067 | Seoul | |
| Korea, Republic of | SK190 | Seoul | |
| Poland | PO013 | Bialystok | |
| Poland | PO010 | Bydgoszcz | |
| Poland | PO024 | Bydgoszcz | |
| Poland | PO092 | Katowice | |
| Poland | PO107 | Katowice | |
| Poland | PO009 | Poznan | |
| Poland | PO014 | Szczecin | |
| Poland | PO074 | Warszawa | |
| Serbia | SE090 | Belgrade | |
| Serbia | SE164 | Belgrade | |
| Serbia | SE193 | Belgrade | |
| Serbia | SE155 | Kragujevac | |
| Serbia | SE031 | Novi Kneževac | |
| Serbia | SE165 | Vršac | |
| Singapore | SI026 | Singapore | |
| Singapore | SI052 | Singapore | |
| Slovakia | SL056 | Banska Bystrica | |
| Slovakia | SL200 | Dubnica nad Vahom | |
| Slovakia | SL078 | Krompachy | |
| Slovakia | SL078 | Krompachy | |
| Slovakia | SL077 | Svidník | |
| Spain | SP249 | Alicante | |
| Spain | SP021 | Barcelona | |
| Spain | SP022 | Barcelona | |
| Spain | SP176 | Barcelona | |
| Spain | SP184 | Barcelona | |
| Spain | SP250 | Barcelona | |
| Spain | SP222 | Getxo | |
| Spain | SP194 | San Sebastián | |
| Taiwan | TA121 | Taoyuan | |
| United Kingdom | UK063 | Bath | |
| United Kingdom | UK038 | Blackpool | |
| United Kingdom | UK233 | Cambridge | |
| United Kingdom | UK033 | Carnoch | |
| United Kingdom | UK211 | Epping | |
| United Kingdom | UK234 | Guildford | |
| United Kingdom | UK055 | Leeds | |
| United Kingdom | UK039 | London | |
| United Kingdom | UK034 | Manchester | |
| United Kingdom | UK087 | Oxford | |
| United Kingdom | UK235 | Plymouth | |
| United Kingdom | UK100 | Sheffield | |
| United Kingdom | UK064 | Southampton | |
| United Kingdom | UK152 | Southampton | |
| United Kingdom | UK153 | Swindon | |
| United Kingdom | UK154 | Warrington | |
| United States | US001 | Albany | New York |
| United States | US046 | Atlanta | Georgia |
| United States | US048 | Atlanta | Georgia |
| United States | US088 | Atlantis | Florida |
| United States | US111 | Baton Rouge | Louisiana |
| United States | US135 | Berlin | New Jersey |
| United States | US049 | Brooklyn | New York |
| United States | US007 | Brooksville | Florida |
| United States | US150 | Chapel Hill | North Carolina |
| United States | US185 | Charlotte | North Carolina |
| United States | US149 | Charlottesville | Virginia |
| United States | US008 | Cincinnati | Ohio |
| United States | US113 | Cleveland | Ohio |
| United States | US217 | Columbus | Georgia |
| United States | US002 | Hallandale Beach | Florida |
| United States | US179 | Hamden | Connecticut |
| United States | US144 | Hattiesburg | Mississippi |
| United States | US140 | Hialeah | Florida |
| United States | US094 | Las Vegas | Nevada |
| United States | US197 | Lawrenceville | New Jersey |
| United States | US057 | Manchester | New Jersey |
| United States | US169 | Media | Pennsylvania |
| United States | US110 | Miami | Florida |
| United States | US216 | Miami | Florida |
| United States | US215 | Mount Arlington | New Jersey |
| United States | US097 | New Hyde Park | New York |
| United States | US044 | New York | New York |
| United States | US116 | Newton | Massachusetts |
| United States | US172 | North Palm Beach | Florida |
| United States | US171 | Norwich | Connecticut |
| United States | US143 | Orem | Utah |
| United States | US003 | Orlando | Florida |
| United States | US256 | Pensacola | Florida |
| United States | US112 | Phoenix | Arizona |
| United States | US162 | Plains | Pennsylvania |
| United States | US134 | Portland | Oregon |
| United States | US174 | Quincy | Massachusetts |
| United States | US096 | Rancho Mirage | California |
| United States | US043 | San Antonio | Texas |
| United States | US195 | Santa Ana | California |
| United States | US119 | Shaker Heights | Ohio |
| United States | US095 | Shreveport | Louisiana |
| United States | US016 | Simi Valley | California |
| United States | US170 | Spokane | Washington |
| United States | US037 | Tampa | Florida |
| United States | US042 | Tampa | Florida |
| United States | US106 | Temecula | California |
| United States | US004 | The Villages | Florida |
| United States | US209 | Toms River | New Jersey |
| United States | US220 | Tucson | Arizona |
| United States | US036 | West Long Branch | New Jersey |
| United States | US148 | Willow Grove | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Axovant Sciences Ltd. |
United States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Czechia, France, Germany, Italy, Korea, Republic of, Poland, Serbia, Singapore, Slovakia, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments | The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments | Baseline to 12 months or Early Termination |
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