Acute Ischemic StrokePhase 3NCT05154903
Citicoline in Ischemic Stroke
A Phase 3 study testing Citicoline 500 MG in people with Acute Ischemic Stroke, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Citicoline 500 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2021to 22 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
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- 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
Who cannot join
- 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.
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- 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,…).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Citicoline in Acute Ischemic Stroke
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
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Citicoline 500 MG
- Keywords
- citicoline, Egypt, ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline 500 MGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Citicoline | Active comparator | 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 Receives: Drug: Citicoline 500 MG |
| control | No intervention | the control group will not receive citicoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start22 Jul 2021
- Primary completion22 Apr 2022 (estimated)
- Study completion22 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, Hossam Shokri, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154903
- Sponsor's protocol ID
- 5555
- Status last verified
- Feb 2022
- First submitted
- 6 Oct 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be available upon appropriate request from authors
Publications
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.
PubMed 12271462Alvarez-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.
PubMed 24961534Cho 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.
PubMed 19536360
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citicoline in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05154903
- Acronym / sponsor ID
- 5555
- Conditions
- Acute Ischemic Stroke
- Keywords
- citicoline, Egypt, ischemic stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 22 Apr 2022 (estimated)
- Study completion
- 22 Jun 2022 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Citicoline | Active comparator | Drug: Citicoline 500 MGthe 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 |
| control | No intervention | –the control group will not receive citicoline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- - 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citicoline 500 MGCiticoline 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. | Drug | Citicoline |
Primary outcome
percentage of patients with a good outcome using modified Rankin scale
Time frame: 3 months
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)
1 secondary outcome
Incidence of Citicoline-Emergent Adverse Events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 12271462Adibhatla 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.
- Background: PubMed 24961534Alvarez-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.
- Background: PubMed 19536360Cho 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.
- pubmedLink provided by the sponsor.
- pubmedLink provided by the sponsor.
- pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. data will be available upon appropriate request from authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Citicoline 500 MG in people with Acute Ischemic Stroke, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossam Shokri (2001283561099, hossam.shokri@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with a good outcome using modified Rankin scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.