Study of the Safety and Tolerability of RVT-101 in patients with Dementia with Lewy Bodies (DLB)
- Conditions
- Dementia with Lewy bodies (DLB)MedDRA version: 20.0Level: PTClassification code 10067889Term: Dementia with Lewy bodiesSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-002412-40-GB
- Lead Sponsor
- Axovant Sciences Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 213
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 (i.e., donepezil, galantamine, rivastigmine, tacrine)
• Memantine
• Axona® (caprylidene)
• Antidepressants (other than MAO inhibitors)
• Thyroid hormones
• Atypical antipsychotics (e.g., quetiapine)
• 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
3. Female subjects must be:
a) Of non-childbearing potential (i.e., any female who is post-menopausal [greater than 1 year without menstrual period in the absence of hormone replacement therapy]) or surgically sterile; or,
b) If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at the Screening/Baseline visit. Female subjects of childbearing potential and who are sexually active are required to use a highly effective method of birth control during the course of the study. Female subjects for whom menopausal status is in doubt, in the opinion of the investigator, will be required to use a highly effective form of birth control. Highly effective forms of birth control are defined as methods that have a failure rate of less than 1% per year when used correctly and consistently and include:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal, or transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system (IUS)
• bilateral tubal occlusion
• vasectomised partner
• sexual abstinence
Subjects who have a positive pregnancy test during the study or become pregnant during the study will be discontinued.
4. Male subjects who are sexually active and whose partner is of child-bearing potential are required to use an adequate form of birth control, including at least 1 barrier method.
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.
7. Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or, if unable to provide informed consent due to cognitive status, subject has provided assent and a legally acceptable representative (LAR) has provided full written informed consent on behalf of the subject.
8. Subject is able to comply with the study procedures in the opinion of t
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method