- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02928445
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- CA200
-
-
-
-
-
Paris, France, 75010
- FR959
-
Paris, France, 75013
- FR960
-
Saint-Herblain, France, 44800
- FR953
-
Strasbourg, France, 67000
- FR950
-
Vandœuvre-lès-Nancy, France, 54500
- FR955
-
-
Haute-Garonne
-
Toulouse, Haute-Garonne, France, 31052
- FR952
-
-
Nord
-
Lille, Nord, France, 59037
- FR957
-
-
Rhone
-
Villeurbanne, Rhone, France, 69100
- FR951
-
-
-
-
-
Brescia, Italy, 25123
- IT306
-
Milano, Italy, 20133
- IT301
-
Venice, Italy, I-30126
- IT305
-
-
Lecce
-
Tricase, Lecce, Italy, 73039
- IT304
-
-
Liguria
-
Genova, Liguria, Italy, 16132
- IT300
-
-
Lombardia
-
Brescia, Lombardia, Italy, 25125
- IT302
-
-
-
-
-
Den Bosch, Netherlands, 5223 GZ
- NE401
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, Netherlands, 1081 HV
- NE402
-
-
-
-
-
Barcelona, Spain, 08028
- SP600
-
Barcelona, Spain, 08041
- SP605
-
-
-
-
-
Bristol, United Kingdom, BS10 5NB
- UK807
-
Dundee, United Kingdom, DD1 9SY
- UK806
-
Isleworth, United Kingdom, TW7 6FY
- UK805
-
London, United Kingdom, SE5 8AF
- UK800
-
London, United Kingdom, W1G 9RU
- UK809
-
Manchester, United Kingdom, M8 5RB
- UK802
-
Newcastle upon Tyne, United Kingdom, NE4 5PL
- UK803
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB21 5EF
- UK801
-
-
Essex
-
Epping, Essex, United Kingdom, CM16 6TN
- UK808
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO30 3JB
- UK804
-
-
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- US138
-
Phoenix, Arizona, United States, 85013
- US108
-
Sun City, Arizona, United States, 85351
- US139
-
Tucson, Arizona, United States, 85704
- US125
-
-
California
-
Orange, California, United States, 92868
- US119
-
Oxnard, California, United States, 93030
- US134
-
Rancho Mirage, California, United States, 92270
- US133
-
Sacramento, California, United States, 95816
- US140
-
-
Colorado
-
Englewood, Colorado, United States, 80113
- US141
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- US123
-
-
Florida
-
Boca Raton, Florida, United States, 33431
- US104
-
Jacksonville, Florida, United States, 32224
- US111
-
Orlando, Florida, United States, 32806
- US122
-
Palm Beach Gardens, Florida, United States, 33410
- US137
-
Tampa, Florida, United States, 33609
- US126
-
-
Georgia
-
Atlanta, Georgia, United States, 30331
- US136
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- US118
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- US105
-
-
Massachusetts
-
Quincy, Massachusetts, United States, 02196
- US130
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- US102
-
-
New York
-
New York, New York, United States, 10032
- US109
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- US100
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- US110
-
Columbus, Ohio, United States, 43210
- US106
-
-
Oregon
-
Portland, Oregon, United States, 97210
- US131
-
-
Pennsylvania
-
Willow Grove, Pennsylvania, United States, 19090
- US120
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- US101
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RVT-101 35 mg
RVT-101 35 mg once daily
|
once daily, oral, 35-mg tablets
|
Experimental: RVT-101 70 mg
RVT-101 70 mg once daily
|
once daily, oral, 35-mg tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RVT-101-2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia With Lewy Bodies
-
EIP Pharma IncWorldwide Clinical TrialsCompletedDementia With Lewy Bodies (DLB)United States, Netherlands
-
Osaka UniversityCompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Inc.CompletedDementias With Lewy BodiesUnited States
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
University Hospital, Strasbourg, FranceRecruitingDementia With Lewy Bodies Diagnosis | Significant Cognitive Fluctuations in DLBFrance
-
Eisai Co., Ltd.Completed
-
CND Life SciencesNational Institute on Aging (NIA)RecruitingMCI-AD, Early Stage Alzheimer's Disease | MCI-DLB, Early Stage Dementia With Lewy BodiesUnited States
-
Cognition TherapeuticsNational Institute on Aging (NIA)RecruitingDementia With Lewy BodiesUnited States
Clinical Trials on RVT-101 35 mg
-
Axovant Sciences Ltd.CompletedDementia With Lewy BodiesUnited States, Canada, France, Italy, Netherlands, Spain, United Kingdom
-
Axovant Sciences Ltd.CompletedAlzheimer's Disease | Dementia With Lewy Bodies | Parkinson's Disease DementiaUnited States
-
Axovant Sciences Ltd.TerminatedAlzheimer's DiseaseUnited States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Czechia, France, Germany, Italy, Korea, Republic of, Poland, Serbia, Singapore, Slovakia, Spain, Taiwan, United Kingdom
-
Immunovant Sciences GmbHTerminatedWarm Autoimmune Hemolytic AnemiaUnited States, Korea, Republic of, Israel, United Kingdom, Spain, Thailand
-
Axovant Sciences Ltd.CompletedAlzheimer's DiseaseUnited States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, France, Germany, Italy, Korea, Republic of, Poland, Serbia, Singapore, Slovakia, Spain, Taiwan, United Kingdom, Czechia
-
Zhejiang Hisun Pharmaceutical Co. Ltd.Unknown
-
Transposon Therapeutics, Inc.Active, not recruitingProgressive Supranuclear PalsyUnited States
-
Emerald Health PharmaceuticalsSuspendedRelapsing Forms of Multiple SclerosisUnited States, Australia
-
Kythera BiopharmaceuticalsCompletedHealthy | Submental FatUnited States, Canada, Australia, United Kingdom
-
Marijn Lijffijt, PhDMichael E. DeBakey VA Medical Center; VistaGen Therapeutics, Inc.Completed