A Phase 3 interventional study of RVT-101 35 mg tablets in Alzheimer's Disease, sponsored by Axovant Sciences Ltd.. Terminated at 169 sites in 19 countries. Open to participants aged 50 Years to 86 Years. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Axovant Sciences Ltd. · Phase 3, Interventional, and Treatment
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 1,099 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Axovant Sciences Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
once daily, oral tablets
Drug: RVT-101 35 mg tablets
once daily, oral tablets
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Time frame: Baseline to 12 months or Early Termination
| Milestone | RVT-101 35 mg Tablets |
|---|---|
| Started | 1099 |
| Completed | 151 |
| Not completed | 948 |
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
| Participants | RVT-101 35 mg Tablets |
|---|---|
| Subjects with at least one on-treatment AE | 549 |
| Subjects with no on-Treatment AE | 550 |
Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RVT-101 35 mg Tablets | 10/1,099 (0.9%) | 87/1,099 (7.9%) | 526/1,099 (47.9%) |
| Event | RVT-101 35 mg Tablets |
|---|---|
| FallInjury, poisoning and procedural complications | 5/1099 |
| DehydrationMetabolism and nutrition disorders | 5/1099 |
| PneumoniaInfections and infestations | 4/1099 |
| GastroenteritisInfections and infestations | 3/1099 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/1099 |
| Atrial fibrillationCardiac disorders | 3/1099 |
| Cardio-respiratory arrestCardiac disorders | 3/1099 |
| CholelithiasisHepatobiliary disorders | 3/1099 |
| Appendicitis perforatedInfections and infestations | 2/1099 |
| Urinary tract infectionInfections and infestations | 2/1099 |
| Event | RVT-101 35 mg Tablets |
|---|---|
| FallInjury, poisoning and procedural complications | 51/1099 |
| Urinary tract infectionInfections and infestations | 45/1099 |
| NasopharyngitisInfections and infestations | 23/1099 |
| Back painMusculoskeletal and connective tissue disorders | 22/1099 |
| Upper respiratory tract infectionInfections and infestations | 18/1099 |
| DiarrhoeaGastrointestinal disorders | 17/1099 |
| DizzinessNervous system disorders | 17/1099 |
| HeadacheNervous system disorders | 17/1099 |
| AgitationPsychiatric disorders | 17/1099 |
| AnxietyPsychiatric disorders | 16/1099 |
| Age, Categorical(Participants) | RVT-101 35 mg Tablets |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 158 |
| >=65 years | 941 |
| Age, Continuous(years) | RVT-101 35 mg Tablets |
|---|---|
| Mean | 73.1 ± 7.55 |
| Sex: Female, Male(Participants) | RVT-101 35 mg Tablets |
|---|---|
| Female | 676 |
| Male | 423 |
| Ethnicity (NIH/OMB)(Participants) | RVT-101 35 mg Tablets |
|---|---|
| Hispanic or Latino | 193 |
| Not Hispanic or Latino | 897 |
| Unknown or Not Reported | 9 |
| Race (NIH/OMB)(Participants) | RVT-101 35 mg Tablets |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 44 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 16 |
| White | 1022 |
| More than one race | 0 |
| Unknown or Not Reported | 16 |
| Region of Enrollment(participants) | RVT-101 35 mg Tablets |
|---|---|
| Argentina | 103 |
| Singapore | 16 |
| United States | 281 |
| Czechia | 53 |
| United Kingdom | 164 |
| Spain | 65 |
| Canada | 37 |
| South Korea | 9 |
| Taiwan | 16 |
| Poland | 47 |
| Italy | 61 |
| Slovakia | 42 |
| Australia | 31 |
| Bulgaria | 7 |
| Chile | 48 |
| France | 13 |
| Serbia | 21 |
| Germany | 55 |
| Croatia | 30 |
| Height(cm) | RVT-101 35 mg Tablets |
|---|---|
| Mean | 163.3 ± 9.86 |
| Weight(kg) | RVT-101 35 mg Tablets |
|---|---|
| Mean | 71.08 ± 14.490 |
1 further baseline measures are reported on the registry.
Showing the first 100 of 169 sites across 19 countries.
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Plan to share: No
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Axovant Sciences Ltd.