N/A
N=2,583
Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
Chronic Cerebral Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT04370028 ↗Enrolled (actual)
2,583
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Mean MoCA Score at Week 1 and the End of the 12-week Therapy — 19.42; 24 score on a scale — p=<0.00001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Divaza (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Materia Medica Holding
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean MoCA Score at Week 1 and the End of the 12-week Therapy |
19.42; 24 | <0.00001 sig |
| SECONDARY The Number of Patients With a MoCA Score <26 at 12 Week |
1676; 1048 | <0.00001 sig |
| SECONDARY The Number of Patients With a MoCA Score ≤ 17 at the End of the 12-week Therapy |
489; 117 | <0.00001 sig |
| SECONDARY The Dynamics of Mean MoCA Score in Each Age Group |
24; 20.94; 19.39; 16.23; 26.4; 25.7 | <0.07 |
| SECONDARY The Number of Patients With a MoCA Score Improvement (Increase in Scores) in Age Groups |
5; 199; 616; 214 | — |
Summary
An open-label, prospective, observational, multicenter study. The study enrolls adult outpatients with CCI from 8 federal districts of the Russian Federation.
Eligibility Criteria
Inclusion Criteria
- Patients of either gender aged 18+ years.
- Diagnosis of chronic cerebral ischemia (CCI) based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs.
- Unchanged basic therapy of CCI and underlying vascular disease for a previous 3 month.
- Signed informed consent form.
Exclusion Criteria
- Other neurological diseases.
- Any known allergy to/intolerance of any constituent of the medication.
- Pregnancy, breast-feeding.
- Participation in other clinical trials for 3 months prior to enrollment in this study.
- The patient is related to the research personnel of the investigative sites that are directly involved in the study, or is the immediate relative of the investigator, or the employee of OOO NPF Materia Medica Holding.
Data sourced from ClinicalTrials.gov (NCT04370028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.