Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of Efficacy and Safety of Divaza in the Management of Oxidative Disturbances in Cerebral Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485495
Recruitment Status : Completed
First Posted : April 2, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Brief Summary:

The purpose of this study is to obtain further data on the efficacy and safety of Divaza therapy for oxidative impairment elimination in patients with cerebral atherosclerosis.

It is assumed that the inclusion of the drug Divaza in the basic therapy will help reduce the severity of cognitive disorders, other clinical symptoms of cerebral atherosclerosis, reduce the impact of the disease on the quality of life of the patient.

Participate in the study may be patients with a diagnosis of "cerebral atherosclerosis", which, against the backdrop of basic therapy with constant doses of drugs (within the last 4 weeks), to achieve a stable course of cerebral atherosclerosis, cognitive disorders without significant disability are detected.


Condition or disease Intervention/treatment Phase
Cerebral Atherosclerosis Drug: Divaza Drug: Placebo Phase 4

Detailed Description:

The diagnosis of "cerebral atherosclerosis" is established in the presence of all three causes: a) the main vascular disease and focal neurological symptoms in combination with cerebral symptoms; b) ultrasound signs of atherosclerotic lesion of the cerebrovascular bed (according to data of duplex scanning of the main arteries of the head (MAG)) made in the previous 6 months before the patient was included in the study); c) signs of morphological changes in the brain substance from the data of neuroimaging.

At cerebral atherosclerosis against the background of progressive oxidant disorders, the change in the mean value of resistance of lipoproteins (LP) to lipid peroxygenation (LPO) will be evaluated by the method of Fe2 + -induced chemiluminescence, high specificity and informativity of which was shown in the study of oxidative and antioxidant systems of patients with initial manifestations of chronic cerebrovascular insufficiency.

The average value of resistance of LP to LPO will be determined in the laboratory initially and after 12 weeks of treatment.

Cognitive disorders are significant clinical manifestations of chronic cerebrovascular disease with oxidative disorders, which significantly reduces the quality of life of patients. Changes in cognitive function will be assessed initially and after 12 weeks of treatment by the Montreal Cognitive Assessment (MoCA).

As additional parameters, changes in the mean values of the levels of pre-formulated products of LPO, the ability of LP to oxidation, NO in serum, platelet aggregation and Carotid Intima-Media Thickness (CIMT) at 12 weeks of therapy as compared to the baseline condition.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Divaza in the Management of Oxidative Disturbances in Cerebral Atherosclerosis
Actual Study Start Date : April 12, 2018
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: Divaza Drug: Divaza

Oral. Single dose: 2 tablets (to be held in the mouth until dissolution is complete).

Dosage regimen: 2 tablets three times daily, not concomitantly with food (i.e., 15-30 minute before eating)


Placebo Comparator: Placebo Drug: Placebo

Oral. Single dose: 2 tablets (to be held in the mouth until dissolution is complete).

Dosage regimen: 2 tablets three times daily, not concomitantly with food (i.e., 15-30 minute before eating)





Primary Outcome Measures :
  1. Change in the mean resistance of lipoprotein (LP) to lipid peroxidation (LPO) from baseline to week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with improved cognitive function (Montreal Cognitive Assessment score +1 and over) from baseline to week 12 [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Change in the mean value of the level of pre-formed products of LPO (mainly lipid hydroperoxides) from baseline to week 12 [ Time Frame: 12 weeks ]
  2. Change in the mean value of the ability of LP to oxidize from baseline to week 12 [ Time Frame: 12 weeks ]
  3. Change in the mean concentration of NO products in serum from baseline to week 12 [ Time Frame: 12 weeks ]
  4. Change in mean platelet aggregation from baseline to week 12 [ Time Frame: 12 weeks ]
  5. Change in mean IMT (intima-media thickness) from baseline to week 12 [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of either sex, aged 40-75 years.
  2. Diagnosis of cerebral atherosclerosis based on the following three factors:

    • underlying vascular disease (atherosclerosis and/or arterial hypertension) and focal neurological signs and symptoms accompanied by nonspecific cerebral symptoms (i.e. headache, dizziness, noise in the head, impairment of memory, fatigue);
    • ultrasound signs of cerebrovascular blood flow defects (on duplex scanning of the main artery of the head for 6 months before to study entry);
    • 1.0-1.5T CT/MRT signs of structural changes in brain matter (subcortical and periventricular leukoaraiosis and/or focal changes in gray and white matter observed as postischemic cysts and/or lacunar infarcts, and/or diffuse atrophic changes observed as ventricular or subarachnoid enlargement).
  3. Cognitive impairments (MoCA (Montreal Cognitive Assessment) <26).
  4. Patients who have been on an unchanged standard medication regimen for cerebral atherosclerosis and arterial hypertension for the previous month.
  5. Agreement to use a reliable method of birth control for the duration of the study.
  6. Provision of signed patient information sheet and informed consent form to participate in the clinical trial.

Exclusion Criteria:

  1. A prior history of subarachnoid/parenchymatous/ventricular hemorrhage, brain neoplasm, or any other condition known to have caused the neurological dysfunction.
  2. Ischemic stroke or any other cerebrovascular accident defined by the Modified Rankin Scale (mRs > 1), within 6 months prior to study entry .
  3. Any known potential cardiac sources of embolism defined by TOAST as medium- to high-risk.
  4. Any previous (within 2 weeks prior to screening) or current signs of an acute infectious disease or exacerbation of a chronic infectious disease.
  5. Prior history of CNS (central nervous system) disorders, including:

    • Inflammatory diseases of the CNS (G00-G09).
    • Systemic atrophies primarily affecting central nervous system (G10-G13).
    • Other degenerative diseases of the nervous system (G30-G32).
    • Demyelinating diseases of the CNS (G35-G37).
  6. Dementia (F00-F03).
  7. Prior diagnosis of heart failure defined by the New York Heart Association classification (1964) as III or IV FC.
  8. Hypothyroidism, diabetes mellitus, or other decompensated somatic disease.
  9. Uncontrolled arterial hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.
  10. Decompensated disease of veins of lower extremities (e.g. varicose veins of lower extremities, thrombosis of deep veins, etc.).
  11. Any other condition which, in the opinion of the investigator, prevents the patient from participating in the study.
  12. Any known or suspected malignant neoplasm.
  13. Allergy to/intolerance of any constituent of the medications used in the treatment.
  14. Hereditary lactose intolerance.
  15. Malabsorption syndrome (lactose intolerance), including congenital or acquired lactase deficiency or any other disaccharidase insufficiency, galactosemia.
  16. Pregnancy, breast-feeding.
  17. Prior history of non-adherence to a drug regimen, a psychiatric disorder, alcoholism, or drug abuse, which, in the opinion of the investigator, can compromise compliance with study protocol.
  18. Use of any medicine listed in the section "Prohibited concomitant treatment" within 1 month preceding the inclusion in this study.
  19. Participation in other clinical trials within the 3 months preceding the inclusion in this study.
  20. Patient is related to the research personnel of the investigative site that are directly involved in the trial, or is the immediate relative of the investigator. The immediate relative includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
  21. Patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for carrying out the research or is an immediate relative of the aforementioned).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485495


Locations
Layout table for location information
Russian Federation
Limited Liability Company "Family policlinic no. 4"
Korolev, Russian Federation, 141060
Moscow City Clinical Hospital after V.M. Buyanov
Moscow, Russian Federation, 115516
State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital No. 1 named after. N.I. Pirogov Moscow Department of Health
Moscow, Russian Federation, 119049
Federal State Budgetary Institution Federal Research and Clinical Center of Physical-Chemical Medicine Federal Medical Biological Agency
Moscow, Russian Federation, 119435
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation
Moscow, Russian Federation, 119992
Federal State Budget Scientific Institution "Scientific Center of Neurology"
Moscow, Russian Federation, 1253678
The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"
Vladimir, Russian Federation, 600023
Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation
Yaroslavl, Russian Federation, 150000
State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8
Yaroslavl, Russian Federation, 150030
State budgetary institution of health care of the Yaroslavl region "Regional Clinical Hospital"
Yaroslavl, Russian Federation, 150062
Sponsors and Collaborators
Materia Medica Holding

Layout table for additonal information
Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03485495     History of Changes
Other Study ID Numbers: MMH-DV-010
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Arteriosclerosis
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases