Lewy Body DementiaPhase 2NCT02871427
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
A Phase 2 study testing Nelotanserin in people with Lewy Body Dementia and Dementia With Lewy Bodies, run by Axovant Sciences Ltd. at 19 sites in United States.
Trial summary
This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lewy Body Dementia, Dementia With Lewy Bodies, Parkinson's Disease Dementia
- What is being tested?
- Nelotanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 19 sitesUnited States
- Study dates
- 20 Oct 2016to 17 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with LBD who completed a previous nelotanserin VH or RBD study
Who cannot join
- Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
US120
Birmingham, Alabama, 35294
US114
Boca Raton, Florida, 33486
US101
Chapel Hill, North Carolina, 27514
US111
Cincinnati, Ohio, 45229
US104
Cleveland, Ohio, 44195
US105
Columbus, Ohio, 43210
US147
Fargo, North Dakota, 58103
US107
Indianapolis, Indiana, 46202
US132
Lenexa, Kansas, 66214
US129
Lincoln, Nebraska, 68526
US173
Lincoln, Rhode Island, 02865
US143
Little Rock, Arkansas, 77205
US180
Maitland, Florida, 32751
US128
Memphis, Tennessee, 38163
US154
Ocala, Florida, 34471
US113
Orlando, Florida, 32806
US152
Ormond Beach, Florida, 32174
US103
Rochester, Minnesota, 55905
US131
San Antonio, Texas, 78229
About this study
Official title: An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder
This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).
Read the detailed description
This is a multi-center open-label, long-term study in LBD subjects with RBD and/or VHs. Eligible subjects who completed a previous nelotanserin VH or RBD study and choose to participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once daily for 24 weeks.
- Conditions
- Lewy Body Dementia, Dementia With Lewy Bodies, Parkinson's Disease Dementia, Visual Hallucinations, REM Sleep Behavior Disorder
- Being tested
- Nelotanserin
- Keywords
- Lewy body dementia, Dementia with Lewy bodies, Parkinson's disease dementia, Visual hallucinations, REM sleep behavior disorder
- Medical subject headings
- Lewy Body Disease, Hallucinations, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelotanserinDrug
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
| Study group | Role | What they receive |
|---|---|---|
| Nelotanserin | Experimental | Once Daily, Oral, at 20, 40, 60, or 80 mg dose Receives: Drug: Nelotanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment.
Measured: 24 weeks
Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start20 Oct 2016
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Why it stopped: Changes to the overall development program for the study medication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axovant Sciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilise Lombardo, MD, Study director, Axovant Sciences, Inc., Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871427
- Sponsor's protocol ID
- RVT-102-2003
- Status last verified
- Mar 2019
- First submitted
- 15 Aug 2016
- Last updated
- 27 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT02871427
- Acronym / sponsor ID
- RVT-102-2003
- Conditions
- Lewy Body Dementia, Dementia With Lewy Bodies, Parkinson's Disease Dementia, Visual Hallucinations, REM Sleep Behavior Disorder
- Keywords
- Lewy body dementia, Dementia with Lewy bodies, Parkinson's disease dementia, Visual hallucinations, REM sleep behavior disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes to the overall development program for the study medication
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Axovant Sciences Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).
Detailed description
This is a multi-center open-label, long-term study in LBD subjects with RBD and/or VHs. Eligible subjects who completed a previous nelotanserin VH or RBD study and choose to participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once daily for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelotanserin | Experimental | Drug: NelotanserinOnce Daily, Oral, at 20, 40, 60, or 80 mg dose |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with LBD who completed a previous nelotanserin VH or RBD study
Key exclusion criteria (1 listed)
- Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NelotanserinOnce Daily, Oral, at 20, 40, 60, or 80 mg dose | Drug | Nelotanserin |
Primary outcome
Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment.
Time frame: 24 weeks
Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment.
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Changes to the overall development program for the study medication). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Click on Nelotanserin for more informationLink provided by the sponsor.
Related trials for Lewy Body Dementia
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
Transcranial Alternating Current Stimulation in Lewy Body Dementia
Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
RecruitingPhase 2
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Cognitive Dysfunction, Lewy Body Disease
RecruitingPhase 2
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
RecruitingPhase 3
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilise Lombardo, MD study director
Axovant Sciences, Inc., Clinical Research
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nelotanserin in people with Lewy Body Dementia and Dementia With Lewy Bodies, run by Axovant Sciences Ltd. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Changes to the overall development program for the study medication). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment. (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.