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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
Axovant Sciences Ltd.

Tracking Information
First Submitted Date  ICMJE January 25, 2016
First Posted Date  ICMJE February 1, 2016
Results First Submitted Date  ICMJE December 31, 2018
Results First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Change from baseline on Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) [ Time Frame: 24 weeks ]
  • Change from baseline on a computerized cognitive battery [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Change from baseline on a clinical assessment of visual hallucinations [ Time Frame: up to 24 weeks ]
  • Occurrence of reported adverse events and findings noted by investigators on clinical examination, electrocardiograms, and routine laboratory assessments [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Official Title  ICMJE A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Brief Summary This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dementia With Lewy Bodies
Intervention  ICMJE
  • Drug: RVT-101 35 mg
    once daily, oral, 35-mg tablets
  • Drug: RVT-101 70 mg
    once daily, oral, 35-mg tablets
  • Drug: Placebo
    once daily, oral, matching tablets
Study Arms  ICMJE
  • Experimental: RVT-101 35 mg
    RVT-101 35 mg once daily
    Intervention: Drug: RVT-101 35 mg
  • Experimental: RVT-101 70 mg
    RVT-101 70 mg once daily
    Intervention: Drug: RVT-101 70 mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2019)
484
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2016)
240
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02669433
Other Study ID Numbers  ICMJE RVT-101-2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axovant Sciences Ltd.
Study Sponsor  ICMJE Axovant Sciences Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ilise Lombardo, MD Axovant Sciences Inc., Senior Vice President, Clinical Research
PRS Account Axovant Sciences Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP