To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in subjects with DLB
ID
Source
Brief title
Condition
- Mental impairment disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety evaluation: Safety will be evaluated based on adverse events (AEs),
physical and neurological examinations, vital signs (including measurements of
orthostatic changes in blood pressure [BP] and heart rate [HR]),
electrocardiograms (ECGs), questionnaire for signs of potential orthostasis
(QSO), Columbia-Suicide Severity Rating Scale (C-SSRS) and clinical laboratory
assessments.
Secondary outcome
None
Background summary
This RVT-101-2002 study is an extension study to the RVT-101-2001 to
investigate how well RVT-101 works to improve cognitive and overall function as
well as to investigate the safety of RVT-101. The present study is to the
Safety and Tolerability of RVT-101 in the same subjects who participated in the
RVT-101-2001 study.
It is believed that patients with dementia with Lewy bodies have an imbalance
of acetylcholine, which is a chemical in the brain thought to be responsible
for cognition. RVT-101 promotes the release of acetylcholine in the brain,
RVT-101 is in the RVT-101-2001 phase 2b study tested to assess whether the drug
can promote cognitive and overall functioning in patients with Lewy Body
Dementia.
Study objective
To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in
subjects with DLB
Study design
This is a multi-center extension study. The safety and tolerability of RVT-101
at doses of 35 mg and 70 mg daily will be evaluated over a 24-week treatment
period in subjects with probable DLB who have participated in Study
RVT-101-2001, *A Phase 2b, double-blind, randomized, placebo-controlled study
of RVT-101 in subjects with dementia with Lewy bodies (DLB).* Subjects who
were randomized to treatment arms RVT-101 35 mg and RVT-101 70 mg in Study
RVT-101-2001 will remain in those same treatment groups for this study, while
subjects who were randomized to placebo in Study RVT-101-2001 will be assigned
to the RVT-101 70 mg treatment group. Treatment assignments for this study will
be double-blind until Study RVT-101-2001 database is locked and unblinded;
after that the treatment assignments will be double-blind, but Sponsor-open,
meaning the subject and investigator will not know what treatment assignment
he/she has been given but the Sponsor and its representatives will.
Study burden and risks
Burden, - questionnaires blood drawn at 7 visits, physical exam. See section
8.1 Study assessments and procedures van protocol v1.0 dd 23May2016.
As with taking any drug, there is a risk of allergic reaction. Some things that
may happen during an allergic reaction are:
. Rash or hives
. Having a hard time breathing
. Wheezing when you breathe
. Sudden change in blood pressure, which may make you feel dizzy or lightheaded
. Swelling around the mouth, throat or eyes
. Fast pulse
. Sweating
The study may provide scientific data useful in the future.
Bornweg 12C
Bennekom 6721 AH
NL
Bornweg 12C
Bennekom 6721 AH
NL
Listed location countries
Age
Inclusion criteria
1. Male or female subjects who have completed the last on-treatment visit (Visit 12) of the lead-in study (RVT-101-2001). Subjects who were prematurely discontinued from the lead-in study may be enrolled in this study only after discussion with the Medical Monitor. The number of subjects enrolled in this study who did not complete the lead-in study (RVT-101-2001) will be capped at 12.
2. If the subject is currently receiving any of the following medications or non-medication therapies, the treatment regimen has been stable (i.e., no changes in the type of drug, dose or frequency of dosing) for at least 30 days prior to the Screening/Baseline Visit and there is no intent to change this treatment regimen up to Visit 4 of this study.
• Acetylcholinesterase inhibitors
• Memantine
• Axona® (caprylidene)
• Antidepressants (other than MAO inhibitors)
• Thyroid hormones
• Atypical antipsychotics
• Benzodiazepines and other sedatives/hypnotics
Note: Benzodiazepines or other sedatives/hypnotics (including antihistamines) with half-life less than 6 hours can be taken on an as needed basis.
• Cognitive tasks for cognitive rehabilitation under medical supervision
• Neurostimulation;5. Subject continues to be able to ingest pills (in tablet form) whole.
6. Subject has a caregiver who has signed an agreement to oversee the subject*s compliance with IP and protocol-specified procedures and report on subject*s health status.
Exclusion criteria
1. Subject who, at Visit 1, is experiencing an ongoing, uncontrolled AE(s) from the lead-in study (RVT-101-2001) or did experience an uncontrolled AE in the lead-in study (RVT-101-2001) that might prevent the subject from safely participating in the study in the opinion of the investigator. Subjects who experienced an SAE that was deemed related, possibly related or probably related to IP during the lead-in study may be considered for participation in this study only after discussion with the Medical Monitor.
2. Subject who, in the opinion of the investigator, had a clinically significant vital sign or ECG abnormality at Visit 12 of the lead-in study, or at the Screening/Baseline visit for this study, that would prevent the subject from safely participating in this study.
3. Subject who, in the opinion of the investigator, had a clinically significant laboratory abnormality at Visit 11 or Visit 12 of the lead-in study, or at the Screening/Baseline visit for this study, that would prevent the subject from safely participating in this study. Investigators need not wait for laboratory results at Visit 12 of the lead-in study or the Screening/Baseline Visit of this study before enrolling the subject in this study. However, any clinically significant abnormality subsequently identified from Visit 12 of the lead-in study and/or at the Screening/Baseline visit for this study will be evaluated by the investigator and the subject assessed for continued participation.
4. Subject who, in the opinion of the investigator, has any confounding medical or psychiatric condition that would prevent the subject from safely participating in this study.
5. Significant suicide risk as defined by (a) suicidal ideation as endorsed on items 4 or 5 of the suicidal ideation section of the Since Last Visit version C-SSRS at the Screening/Baseline visit of this study or (b) any suicidal behaviour endorsed on the Since Last Visit version of the C-SSRS at the Screening/Baseline visit of this study, or (c) clinical assessment of significant suicidal risk.
6. Treatment with any concomitant medication detailed in Table 1. Prohibited medications as outlined in Table 1 unless otherwise specified, need to have been discontinued for 5 half-lives prior to the Screening/Baseline Visit and assessed as no longer clinically necessary for the subject.
7. Confirmed corrected QT interval (QTc) value >= 450 msec for males or >= 470 msec for females at the Screening/Baseline visit for this study. Subjects with a QRS value greater than 120 msec and subjects with a QTc value less than 500 msec may be eligible following discussion with the Medical Monitor.
8. Subject who, in the investigator*s opinion, is unable to take the IP product as directed throughout the study (with assistance is acceptable) or who has demonstrated significant non-compliance with IP in the lead-in study (RVT-101-2001).
9. Subject or caregiver is an immediate family member or employee of the participating investigator, any of the participating site staff, or of the sponsor study staff.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002412-40-NL |
| CCMO | NL59450.056.16 |