Clinical Trial of Efficacy and Safety of Divaza for Adjustment of Oxidative Disorders in Patients With Cerebral Atherosclerosis

NCT03485495 | Completed Phase 4 Results

• 1 other identifier: MMH-DV-010
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to obtain additional data on efficacy and safety of Divaza for adjustment of oxidative disorders 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.

Conditions

Cerebral Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in Mean Value of Lipoprotein Resistance to LPO.

  Based on laboratory evaluation. Change in the mean resistance of lipoprotein (LP) to lipid peroxidation (LPO) after 12-week therapy versus baseline.

  12 weeks of the observation period.

Secondary Outcomes (1)

• Percentage of Patients With Improved Cognitive Function.

  12 weeks of the observation period.

Other Outcomes (4)

• Change in Mean Level of Preformed LP Products (Mainly Lipid Hydroperoxides).

  12 weeks of the observation period

• Change in Mean Value of Lipoprotein Ability for Oxidation.

  12 weeks of the observation period.

• Change in Mean Value of NO Products Serum Concentration.

  12 weeks of the observation period.

Study Arms (2)

Divaza

EXPERIMENTAL

Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.

Drug: Divaza

Placebo

PLACEBO COMPARATOR

Tablet for oral use. Two tablets per intake 3 times a day (approximately at the same time), outside of meal (between meals or 15 minutes before eating or drinking). The tablets should be held in mouth until completely dissolved.

Drug: Placebo

Interventions

Divaza DRUG

Oral administration.

Divaza

Placebo DRUG

Oral administration.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders aged 40-75 years old inclusive.
• Diagnosis of cerebral atherosclerosis verified by all three signs:
• underlying vascular disease (atherosclerosis and/or hypertension) and focal neurological symptoms combined with cerebral symptoms (headache, dizziness, tinnitus, impaired memory, working capacity);
• ultrasound signs of atherosclerotic cerebrovascular lesions (according to MAH duplex scanning within 6 months preceding the patient enrollment into the study);
• signs of morphological changes in the brain based on neuroimaging (CT/MRI 1.0-1.5 T) (subcortical and periventricular leukoaraiosis and/or focal changes in grey matter and white matter in the form of postischemic cysts and/or lacunar strokes and/or diffuse atrophic changes in the form of dilated cardiovascular system or subarachnoidal spaces).
• Cognitive disorders (MoCa \<26).
• Patients with unchanged dose and combination of basic therapy of cerebral atherosclerosis and hypertension during the previous month.
• Patients who gave their consent to use reliable contraception during the study.
• Availability of signed patient information sheet and informed consent form for participation in the clinical trial.

You may not qualify if:

• History of subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral tumour or another disease resulting in neurological disorders.
• Ischemic-type stroke or any other acute cerebrovascular accident less than 6 months prior to the study with Modified Rankin Scale (mRs) \> 1 .
• Cardiac sources of high risk or medium risk embolism (TOAST criteria).
• Signs of acute or exacerbated chronic infectious diseases at or less than 2 weeks prior to screening.
• History of CNS diseases including:
• Inflammatory CNS diseases (G00-G09)
• Systemic Atrophies Primarily Affecting the CNS (G10-G13)
• Other degenerative diseases of the nervous system (G30-G32)
• Demyelinating diseases of the CNS (G35-G37).
• Dementia (F00-F03).
• Previously diagnosed cardiovascular diseases with functional class III or IV (according to New York Heart Association, 1964).
• Hypothyroidism, diabetes mellitus and other somatic diseases at decompensation stage.
• Uncontrollable hypertension: SBP \> 180 mm Hg and/or DBP \> 110 mm Hg.
• Diseases of lower limb veins (lower limb varicose veins, deep venous thrombosis, etc.) at decompensation stage.
• Any other severe concomitant pathology which, according to the investigator, may interfere with the patient's participation in the study.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (10)

Limited Liability Company "Family policlinic no. 4"

Korolyov, 141060, Russia

Location

Moscow City Clinical Hospital after V.M. Buyanov

Moscow, 115516, Russia

Location

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, 119049, Russia

Location

Federal State Budgetary Institution Federal Research and Clinical Center of Physical-Chemical Medicine Federal Medical Biological Agency

Moscow, 119435, Russia

Location

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, 119992, Russia

Location

Federal State Budget Scientific Institution "Scientific Center of Neurology"

Moscow, 1253678, Russia

Location

The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"

Vladimir, 600023, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation

Yaroslavl, 150000, Russia

Location

State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8

Yaroslavl, 150030, Russia

Location

State budgetary institution of health care of the Yaroslavl region "Regional Clinical Hospital"

Yaroslavl, 150062, Russia

Location

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Interventions

divaza

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: April 12, 2018
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: August 26, 2021
• Results First Posted: August 26, 2021

Record last verified: 2019-08

Locations

RU (10)