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Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension

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ClinicalTrials.gov Identifier: NCT02928445
Recruitment Status : Terminated (Intepirdine did not meet its primary efficacy endpoints in the lead-in study RVT-101-2001.)
First Posted : October 10, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )

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.

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies Drug: RVT-101 35 mg Drug: RVT-101 70 mg Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RVT-101 35 mg
RVT-101 35 mg once daily
Drug: RVT-101 35 mg
once daily, oral, 35-mg tablets

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




Primary Outcome Measures :
  1. Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928445


Locations
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Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
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Study Director: Ilise Lombardo, MD Axovant Sciences Inc., Senior Vice President, Clinical Research
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Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02928445    
Other Study ID Numbers: RVT-101-2002
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: February 2018
Keywords provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Dementia with Lewy bodies
dementia
RVT-101
intepirdine
Lewy bodies
Additional relevant MeSH terms:
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Lewy Body Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies