NCT04295681

Brief Summary

The clinical trial to valuate efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2019

Typical duration for phase_3

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 28, 2024

Completed
Last Updated

October 28, 2024

Status Verified

January 1, 2023

Enrollment Period

3.2 years

First QC Date

February 27, 2020

Results QC Date

February 5, 2024

Last Update Submit

August 12, 2024

Conditions

Cognitive Disorders

Outcome Measures

Primary Outcomes (1)

  • Average MoCA Score.

    Montreal Cognitive Assessment Scale (The Montreal Cognitive Assessment, MoCA) will be used to identify moderate cognitive impairment, as well as to assess changes in cognitive functions during therapy. The maximum possible number of points is 30; 26 points or more is considered normal. The minimum score is 0, higher score is better.

    On baseline and on 90th day of the treatment.

Secondary Outcomes (11)

  • Changes in NIHSS Score.

    On baseline, on 12th and on 90th days of the treatment.

  • Percentage of Patients With no Significant Disabilities.

    On 90th day of the treatment.

  • Therapeutic and Side Effects, Efficacy Index.

    On 90th day of the treatment period.

  • Presence of Adverse Events (AEs).

    For 90 days of the treatment period.

  • Percentage of Patients With Complication of Cerebral Infarction.

    For 90 days of the treatment period.

  • +6 more secondary outcomes

Study Arms (2)

MMH-MAP

EXPERIMENTAL

Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.

Drug: MMH-MAP

Placebo

PLACEBO COMPARATOR

Oral administration. For 90 days according to MMH-MAP dosing regimen.

Drug: Placebo

Interventions

MMH-MAPDRUG

Oral administration

Also known as: Prospekta
MMH-MAP
PlaceboDRUG

Oral administration

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40 and 75 years old inclusively.
  • Ischemic stroke in the carotid arteries (I 63) within 72 hours post debut.
  • Moderate cognitive disorders (MoCA \< 26).
  • Normal consciousness (Glasgow score 15)
  • Stroke severity 8-12 according to NIHSS.
  • Disability mRs score 2-3.
  • Availability of cerebral CT/MRI within 72 hours post stroke debut.
  • Patients who agreed to use a reliable method of contraception during the study.
  • Patients who have signed the Participant Information Sheet and Informed Consent.

You may not qualify if:

  • Current or previous subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral infarction, cerebral tumour.
  • Cerebral CT/MRI findings suggesting cerebral hemorrhage, tumour within 72 hours post stroke debut.
  • Scheduled or completed thrombolytic therapy for the treatment of the current cerebral infarction.
  • Central nervous system (CNS) diseases including:
  • Inflammatory diseases of the central nervous system (G00-G09);
  • Systemic atrophies primarily affecting the central nervous system (G10-G13);
  • Extrapyramidal and movement disorders (G20-G26);
  • Other degenerative diseases of the nervous system (G30-G32);
  • Demyelinating diseases of the CNS (G35-G37);
  • Episodic and paroxysmal disorders (G40-G47);
  • Polyneuropathies and other disorders of the peripheral nervous system (G60-64), with marked movement and/or sensory impairments that cause movement disorders;
  • Hydrocephalus (G91).
  • Head injuries (S00-S09) (including history), accompanied by impaired consciousness, brain contusion or open craniocerebral injuries.
  • Musculoskeletal disorders causing motor disturbances.
  • Dementia (including history) (F00-F03).
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

The First City Clinical Hospital named after E.E. Volosevich

Arkhangelsk, 163001, Russia

Location

Arkhangelsk Regional Clinical Hospital/Neurological Department

Arkhangelsk, 163045, Russia

Location

Belgorod Regional Clinical Hospital of St. Joasaph

Belgorod, 308007, Russia

Location

Regional Clinical Hospital # 3

Chelyabinsk, 454021, Russia

Location

Kazan State Medical University/Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan

Kazan', 420012, Russia

Location

Interregional Clinical Diagnostic Center

Kazan', 420101, Russia

Location

City Clinical Hospital # 7

Kazan', 420103, Russia

Location

Research Institute - Regional Clinical Hospital # 1 named after Prof. S.V. Ochapovsky

Krasnodar, 350086, Russia

Location

City Clinical Hospital named after V.M. Buyanov, Moscow Department of Health

Moscow, 115516, Russia

Location

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 117593, Russia

Location

City Clinical Hospital # 5 of the Nizhegorodskiy District of Nizhny Novgorod

Nizhny Novgorod, 603005, Russia

Location

Novosibirsk State Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

Regional Clinic Hospital/Emergency cardiology unit with intensive care and resuscitation unit

Ryazan, 390039, Russia

Location

St. Petersburg Research Institute of Ambulance named after I.I. Janelidze

Saint Petersburg, 192242, Russia

Location

City Multidisciplinary Hospital # 2

Saint Petersburg, 194354, Russia

Location

Samara City Clinical Hospital # 1 named after N.I. Pirogov/Neurological Department

Samara, 443096, Russia

Location

Saratov City Clinical Hospital # 9

Saratov, 410031, Russia

Location

Ulyanovsk Regional Clinical Hospital/Neurological Department

Ulyanovsk, 432063, Russia

Location

Regional Clinic Hospital/Neurological department for patients with acute cerebrovascular accident

Vladimir, 600023, Russia

Location

Voronezh Regional Clinical Hospital # 1

Voronezh, 394066, Russia

Location

Vsevolozhsk Clinical Interdistrict Hospital

Vsevolozhsk, 188643, Russia

Location

Clinical Hospital # 8/Intensive Care Unit

Yaroslavl, 150030, Russia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

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 3
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

February 27, 2020

First Posted

March 4, 2020

Study Start

December 12, 2019

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

October 28, 2024

Results First Posted

October 28, 2024

Record last verified: 2023-01

Locations

RU(22)