Dementia With Lewy BodiesPhase 2/3NCT02928445
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension
A Phase 2/3 study testing RVT-101 35 mg and RVT-101 70 mg in people with Dementia With Lewy Bodies, run by Axovant Sciences Ltd. at 56 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 86 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- RVT-101 35 mg and RVT-101 70 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 56 sitesin 7 countries
- Study dates
- Oct 2016to Feb 2018
- Phase
- Phase 2/3
- 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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participated in the lead-in study RVT-101-2001.
Who cannot join
- Any clinically relevant concomitant disease, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
Trial locations and contacts
56 sites in 7 countries.
56 sites in 7 countries
United States27 sites
US136
Atlanta, Georgia, 30331
US104
Boca Raton, Florida, 33431
US100
Chapel Hill, North Carolina, 27514
US101
Charlottesville, Virginia, 22908
US110
Cleveland, Ohio, 44195
US106
Columbus, Ohio, 43210
US141
Englewood, Colorado, 80113
US118
Indianapolis, Indiana, 46202
US111
Jacksonville, Florida, 32224
US105
Lexington, Kentucky, 40536
US109
New York, New York, 10032
US119
Orange, California, 92868
US122
Orlando, Florida, 32806
US134
Oxnard, California, 93030
US137
Palm Beach Gardens, Florida, 33410
US138
Phoenix, Arizona, 85006
US108
Phoenix, Arizona, 85013
US131
Portland, Oregon, 97210
US130
Quincy, Massachusetts, 02196
US133
Rancho Mirage, California, 92270
US102
Rochester, Minnesota, 55905
US140
Sacramento, California, 95816
US139
Sun City, Arizona, 85351
US126
Tampa, Florida, 33609
US125
Tucson, Arizona, 85704
US123
Washington D.C., District of Columbia, 20007
US120
Willow Grove, Pennsylvania, 19090
United Kingdom10 sites
UK807
Bristol, BS10 5NB
UK801
Cambridge, Cambridgeshire, CB21 5EF
UK806
Dundee, DD1 9SY
UK808
Epping, Essex, CM16 6TN
UK805
Isleworth, TW7 6FY
UK800
London, SE5 8AF
UK809
London, W1G 9RU
UK802
Manchester, M8 5RB
UK803
Newcastle upon Tyne, NE4 5PL
UK804
Southampton, Hampshire, SO30 3JB
France8 sites
FR957
Lille, Nord, 59037
FR959
Paris, 75010
FR960
Paris, 75013
FR953
Saint-Herblain, 44800
FR950
Strasbourg, 67000
FR952
Toulouse, Haute-Garonne, 31052
FR955
Vandœuvre-lès-Nancy, 54500
FR951
Villeurbanne, Rhone, 69100
Italy6 sites
IT302
Brescia, Lombardy, 25125
IT306
Brescia, 25123
IT300
Genoa, Liguria, 16132
IT301
Milan, 20133
IT304
Tricase, Lecce, 73039
IT305
Venice, I-30126
Netherlands2 sites
NE401
's-Hertogenbosch, 5223 GZ
NE402
Amsterdam, North Holland, 1081 HV
About this study
Official title: A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
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.
Read the 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.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- RVT-101 35 mg, RVT-101 70 mg
- Keywords
- Dementia with Lewy bodies, dementia, RVT-101, intepirdine, Lewy bodies
- Medical subject headings
- Lewy Body Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVT-101 35 mgDrug
once daily, oral, 35-mg tablets
RVT-101 70 mgDrug
once daily, oral, 35-mg tablets
| Study group | Role | What they receive |
|---|---|---|
| RVT-101 35 mg | Experimental | RVT-101 35 mg once daily Receives: Drug: RVT-101 35 mg |
| RVT-101 70 mg | Experimental | RVT-101 70 mg once daily Receives: Drug: RVT-101 70 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments
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 posted10 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Intepirdine did not meet its primary efficacy endpoints in the lead-in study RVT-101-2001.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 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., Senior Vice President, Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928445
- Sponsor's protocol ID
- RVT-101-2002
- Status last verified
- Feb 2018
- First submitted
- 7 Oct 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
- ClinicalTrials.gov ID
- NCT02928445
- Acronym / sponsor ID
- RVT-101-2002
- Conditions
- Dementia With Lewy Bodies
- Keywords
- Dementia with Lewy bodies, dementia, RVT-101, intepirdine, Lewy bodies
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intepirdine did not meet its primary efficacy endpoints in the lead-in study RVT-101-2001.
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Axovant Sciences Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 10 Oct 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVT-101 35 mg | Experimental | Drug: RVT-101 35 mgRVT-101 35 mg once daily |
| RVT-101 70 mg | Experimental | Drug: RVT-101 70 mgRVT-101 70 mg once daily |
Who may qualify
- Ages
- 50 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participated in the lead-in study RVT-101-2001.
Key exclusion criteria (1 listed)
- Any clinically relevant concomitant disease, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
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 |
|---|---|---|
| RVT-101 35 mgonce daily, oral, 35-mg tablets | Drug | RVT-101 35 mg |
| RVT-101 70 mgonce daily, oral, 35-mg tablets | Drug | RVT-101 70 mg |
Primary outcome
Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Intepirdine did not meet its primary efficacy endpoints in the lead-in study RVT-101-2001.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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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., Senior Vice President, Clinical Research
56 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RVT-101 35 mg and RVT-101 70 mg in people with Dementia With Lewy Bodies, run by Axovant Sciences Ltd. at 56 sites in 7 countries.
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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, United Kingdom, France, Italy, Netherlands and 2 more countries. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Intepirdine did not meet its primary efficacy endpoints in the lead-in study RVT-101-2001.). 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?
Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments (time frame: 24 weeks). 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 18 Apr 2018.