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Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

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ClinicalTrials.gov Identifier: NCT02669433
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )

Study Description
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Brief Summary:
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

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

Detailed Description:

The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.

The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).

Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
once daily, oral, matching tablets


Outcome Measures
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Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24 [ Time Frame: Change from Baseline at 24 weeks ]
    The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.


Secondary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24 [ Time Frame: Change from Baseline at 24 weeks ]
    The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.

  2. Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24 [ Time Frame: Change from Baseline at 24 weeks ]
    To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject with probable DLB
  • Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
  • Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
  • Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
  • Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion Criteria:

  • Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
  • Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.
Contacts and Locations
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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): NCT02669433


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
  Study Documents (Full-Text)

Documents provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Study Protocol  [PDF] November 15, 2017
Statistical Analysis Plan  [PDF] November 14, 2017

More Information
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Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02669433    
Other Study ID Numbers: RVT-101-2001
First Posted: February 1, 2016    Key Record Dates
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019
Last Verified: April 2019
Keywords provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Dementia with Lewy bodies
Lewy bodies
intepirdine
RVT-101
dementia
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
 Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies