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Citicoline in Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status

Recruiting

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Citicoline 500 MG

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring citicoline, Egypt, ischemic stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Both genders aged > 18 years.
Patients must be treated within 24 hours of their initial stroke symptoms onset.
Patients not eligible to receive rTPA.
Patients with a measurable focal neurological deficit (NIHSS score ≥ 8) lasting for a minimum of 60 minutes. This deficit must persist from onset and up to the time of treatment without clinically significant improvement
Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
Patients must have an acute ischemic stroke with symptoms referrable to internal carotid territory.
At inclusion, NIHSS score 8-15, with at least 2 of these points from sections 5 & 6 (motor).
Immediately (i.e. minutes) pre-stroke, mRS ≤ 1. [History of past stroke does not, by itself, preclude study entrance].
Women of childbearing potential must have a negative pregnancy test prior to enrolment.
Signed informed consent (following a full explanation of the nature and purpose of this study, the patient or legal guardian(s) or representative(s) must consent to participate by signing the Informed Consent document

Exclusion Criteria:

Patients eligible for rTPA treatment.
Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a).
CT or conventional MRI evidence of any structural brain disorder other than ischemic stroke.
History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study.
Previous disorders that may confound the interpretation of the neurological scales.
Drug addiction-related disorders.
Pre-existing dementia, when dementia implies a disability, measured as an score of 2 or higher in the previous mRS.
Pre-existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study.
Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening.
Patients under current treatment with citicoline.
Prior (over past 3 months) or concomitant administration of other neuroprotectant drugs (such as nimodipine, vinponcetine, piracetam, cerebrolysin,…).

Sites / Locations

Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Citicoline

control

Arm Description

the Citicoline group will receive citicoline in continuous Iv infusion in a dose of 2000 mg per day for the first week following AIS then by oral route for the next 5 weeks

the control group will not receive citicoline

Outcomes

Primary Outcome Measures

percentage of patients with a good outcome using modified Rankin scale

the investigators will compare the percentage of patients with good outcomes in the citicoline group and control group according to the modified Rankin scale score. the modified Rankin scale (mRS) is a scale used to assess stroke outcomes, it ranges between 0 and 6 and the higher the score the worse the oucome. the investigators defined patients with good outcomes as patients with (mRS) at 3 months of (0-2), and patients with bad outcomes as those with mRS equals (3-6)

Secondary Outcome Measures

Incidence of Citicoline-Emergent Adverse Events

the incidence of each adverse event related to citicoline will be calculated and recorded in CIOMS form and the investigators will compare the incidence of each side effect in the citicoline group and in the control group.

Full Information

NCT ID

NCT05154903

First Posted

October 6, 2021

Last Updated

February 16, 2022

Sponsor

Ain Shams University

Collaborators

Kafrelsheikh University

1. Study Identification

Unique Protocol Identification Number

NCT05154903

Brief Title

Citicoline in Ischemic Stroke

Official Title

Citicoline in Acute Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

April 22, 2022 (Anticipated)

Study Completion Date

June 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

Collaborators

Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

There is evidence that citicoline is the only neuroprotectant able to improve the functional status of the patients after an acute ischemic stroke. Citicoline is a neuroprotectant drug against cerebral ischemia, with positive results, both in experimental and clinical trials, in the treatment of acute stroke and head injuries Also, the safety profile of citicoline is good, and there are no associated problems when the drug is used in this kind to patients The aim of this study is to confirm the efficacy and safety of citicoline in patients with moderate-to-severe acute ischemic stroke in Egypt, according to the characteristics of the medical care in this country

Detailed Description

This is a Prospective Randomized Open-label trial with Blinded Evaluators, Citicoline will be administered in continuous Iv infusion in a dose of 2000 mg per day for the first week following AIS then by oral route for the next 5 weeks. The number of patients needed for this proposal is 200 (100 per group): group 1 (citicoline): receiving citicoline and group 2 (control) not receiving citicoline. A 10% increase will be expected to avoid possible drop-outs. Assessment scales: Eligibility scale: NIHSS score ≥ 8. Outcome scales: modified Rankin Score (mRS) at 3 months Cutoff scores for mRS will be 0-2 as a cut-off point for a good outcome and 3-6 for a bad outcome. Also, a record of all the side effects will be done. Any kind of adverse effect must be recorded by filling the CIOMS form. Randomization: computer-generated randomization to either group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

citicoline, Egypt, ischemic stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

This is a Prospective Randomized Open label trial with Blinded Evaluators, Citicoline will be administered in continuous iv infusion in a dose of 2000 mg per day for the first week following AIS then by oral route for the next 5 weeks. The number of patients needed for this proposal is 200 (100 per group): group 1 (citicoline) : receiving citicoline and group 2 (control) not receiving citicoline. A 10% increase will be expected to avoid possible drop-outs.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Citicoline

Arm Type

Active Comparator

Arm Description

the Citicoline group will receive citicoline in continuous Iv infusion in a dose of 2000 mg per day for the first week following AIS then by oral route for the next 5 weeks

Arm Title

control

Arm Type

No Intervention

Arm Description

the control group will not receive citicoline

Intervention Type

Drug

Intervention Name(s)

Citicoline 500 MG

Intervention Description

Citicoline will be administered in continuous iv infusion in a dose of 2000 mg per day for the first week following AIS then by oral route for the next 5 weeks.

Primary Outcome Measure Information:

Title

percentage of patients with a good outcome using modified Rankin scale

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Incidence of Citicoline-Emergent Adverse Events

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Both genders aged > 18 years. Patients must be treated within 24 hours of their initial stroke symptoms onset. Patients not eligible to receive rTPA. Patients with a measurable focal neurological deficit (NIHSS score ≥ 8) lasting for a minimum of 60 minutes. This deficit must persist from onset and up to the time of treatment without clinically significant improvement Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized. Patients must have an acute ischemic stroke with symptoms referrable to internal carotid territory. At inclusion, NIHSS score 8-15, with at least 2 of these points from sections 5 & 6 (motor). Immediately (i.e. minutes) pre-stroke, mRS ≤ 1. [History of past stroke does not, by itself, preclude study entrance]. Women of childbearing potential must have a negative pregnancy test prior to enrolment. Signed informed consent (following a full explanation of the nature and purpose of this study, the patient or legal guardian(s) or representative(s) must consent to participate by signing the Informed Consent document Exclusion Criteria: Patients eligible for rTPA treatment. Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a). CT or conventional MRI evidence of any structural brain disorder other than ischemic stroke. History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study. Previous disorders that may confound the interpretation of the neurological scales. Drug addiction-related disorders. Pre-existing dementia, when dementia implies a disability, measured as an score of 2 or higher in the previous mRS. Pre-existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study. Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening. Patients under current treatment with citicoline. Prior (over past 3 months) or concomitant administration of other neuroprotectant drugs (such as nimodipine, vinponcetine, piracetam, cerebrolysin,…).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hossam Shokri

Phone

2001283561099

hossam.shokri@med.asu.edu.eg

Facility Information:

Facility Name

Ain Shams University

City

Cairo

ZIP/Postal Code

88211

Country

Egypt

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

data will be available upon appropriate request from authors

IPD Sharing Time Frame

upon finishing study

IPD Sharing Access Criteria

upon proper request from the author

Citations:

PubMed Identifier

12271462

Citation

Adibhatla RM, Hatcher JF. Citicoline mechanisms and clinical efficacy in cerebral ischemia. J Neurosci Res. 2002 Oct 15;70(2):133-9. doi: 10.1002/jnr.10403.

Results Reference

background

PubMed Identifier

24961534

Citation

Alvarez-Sabin J, Roman GC. The role of citicoline in neuroprotection and neurorepair in ischemic stroke. Brain Sci. 2013 Sep 23;3(3):1395-414. doi: 10.3390/brainsci3031395.

Results Reference

background

PubMed Identifier

19536360

Citation

Cho HJ, Kim YJ. Efficacy and safety of oral citicoline in acute ischemic stroke: drug surveillance study in 4,191 cases. Methods Find Exp Clin Pharmacol. 2009 Apr;31(3):171-6. doi: 10.1358/mf.2009.31.3.1364241.

Results Reference

background

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/12271462

Description

pubmed

URL

https://pubmed.ncbi.nlm.nih.gov/24961534

Description

pubmed

URL

https://pubmed.ncbi.nlm.nih.gov/19536360

Description

pubmed

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Citicoline in Ischemic Stroke

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