Acute Ischemic StrokePhase 4NCT03686163
Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke
A Phase 4 study testing Nerve Growth Factors and normal saline in people with Acute Ischemic Stroke, run by Jinling Hospital, China at 1 site in China.
Trial summary
Stroke remains one of the leading causes of death and adult disability worldwide. Yet, currently, the only accepted treatment for acute ischemic stroke(AIS) is recanalization of occluded arteries. 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?
- Nerve Growth Factors and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to 31 Dec 2020
- Phase
- Phase 4
- 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
- Age ≥18years;
- Acute ischemic stroke consistent within 72 hours;
- Written informed consent from patient or surrogate, if unable to provide consent.
Who cannot join
- Premorbid mRS ≥ 3 points;
- Currently in pregnant or lactating;
- Allergy to NGF;
- Current participation in another investigation drug or device study;
- Life expectancy less than 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Stroke remains one of the leading causes of death and adult disability worldwide. Yet, currently, the only accepted treatment for acute ischemic stroke(AIS) is recanalization of occluded arteries. Thrombolysis with tissue plasminogen activator, limited by its narrow therapeutic time window and the concern of hemorrhagic complication, is still uncommon in use. The other approach is to try to impede the ischemic cascade by targeting various components of the cascade that are deemed to be of importance, namely, a neuroprotection strategy.
Nerve growth factor (NGF) plays extensive roles in preventing ischemic injury. Besides that, it is also involved in neurogenesis of the central nervous system (CNS). In addition, the levels of NGF protein and messenger RNA significantly decreased in the CNS at the first few hours and returned to normal levels several days later after middle cerebral artery occlusion (MCAO) in animal models. These observed results suggested that NGF was demanded in ischemic brain injury, but endogenous NGF is insufficient for the requirement and delivering exogenous ones will be blocked in entering into the CNS by the blood-brain barrier (BBB). Intracerebroventricular or intracerebral injection of NGF or grafting of NGF-producing cells may be less practicable due to invasiveness and safety concerns.
Read more
Intranasal (IN) administration is a noninvasive and acceptable delivery strategy for drugs bypassing BBB and can deliver NGF to the CNS, which has been proved to show neuroprotective effects on brain injury.
The effects of intranasal NGF in human ischemic stroke is still controversial that need further evaluation.
Read the detailed description
The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post acute ischemic stroke, continuing for 2 weeks.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Nerve Growth Factors, normal saline
- Keywords
- Acute Ischemic stroke, Nerve Growth Factor, Intranasal, Neurological Function
- Medical subject headings
- Ischemic Stroke, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Growth FactorsDrug
the experimental group patients will receive NGF 20ug/d intranasally for 2 weeks
normal salineDrug
The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| IN-NGF group | Experimental | Patients who underwent acute ischemic stroke will be chosen to receive NGF randomly Receives: Drug: Nerve Growth Factors |
| Control group | Placebo comparator | Patients who underwent acute ischemic stroke will be chosen to receive normal saline randomly Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
a favorable neurological function
The primary outcome is determined as a favorable neurological function which is defined as Modified Rankin Scale(mRS) score of 0-3
Measured: at 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study startJan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinfeng Liu, Jinling Hospital, China
- Investigators
- Xinfeng Liu, MD, Study chair, Department of Neurology, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686163
- Sponsor's protocol ID
- NGF-ischemic stroke
- Status last verified
- Aug 2021
- First submitted
- 25 Sep 2018
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03686163
- Acronym / sponsor ID
- NGF-ischemic stroke
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic stroke, Nerve Growth Factor, Intranasal, Neurological Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Sep 2018 (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.
Stroke remains one of the leading causes of death and adult disability worldwide. Yet, currently, the only accepted treatment for acute ischemic stroke(AIS) is recanalization of occluded arteries. Thrombolysis with tissue plasminogen activator, limited by its narrow therapeutic time window and the concern of hemorrhagic complication, is still uncommon in use. The other approach is to try to impede the ischemic cascade by targeting various components of the cascade that are deemed to be of importance, namely, a neuroprotection strategy.
Nerve growth factor (NGF) plays extensive roles in preventing ischemic injury. Besides that, it is also involved in neurogenesis of the central nervous system (CNS). In addition, the levels of NGF protein and messenger RNA significantly decreased in the CNS at the first few hours and returned to normal levels several days later after middle cerebral artery occlusion (MCAO) in animal models. These observed results suggested that NGF was demanded in ischemic brain injury, but endogenous NGF is insufficient for the requirement and delivering exogenous ones will be blocked in entering into the CNS by the blood-brain barrier (BBB). Intracerebroventricular or intracerebral injection of NGF or grafting of NGF-producing cells may be less practicable due to invasiveness and safety concerns.
Intranasal (IN) administration is a noninvasive and acceptable delivery strategy for drugs bypassing BBB and can deliver NGF to the CNS, which has been proved to show neuroprotective effects on brain injury.
The effects of intranasal NGF in human ischemic stroke is still controversial that need further evaluation.
Detailed description
The proposed study is a randomized, double-blind, placebo-controlled trail of NGF, starting between 24 to 72 hours post acute ischemic stroke, continuing for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN-NGF group | Experimental | Drug: Nerve Growth FactorsPatients who underwent acute ischemic stroke will be chosen to receive NGF randomly |
| Control group | Placebo comparator | Drug: normal salinePatients who underwent acute ischemic stroke will be chosen to receive normal saline randomly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18years;
- Acute ischemic stroke consistent within 72 hours;
- Written informed consent from patient or surrogate, if unable to provide consent.
Key exclusion criteria (5 listed)
- Premorbid mRS ≥ 3 points;
- Currently in pregnant or lactating;
- Allergy to NGF;
- Current participation in another investigation drug or device study;
- Life expectancy less than 1 year.
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 |
|---|---|---|
| Nerve Growth Factorsthe experimental group patients will receive NGF 20ug/d intranasally for 2 weeks | Drug | IN-NGF group |
| normal salineThe Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks | Drug | Control group |
Primary outcome
a favorable neurological function
Time frame: at 90 days post-treatment
The primary outcome is determined as a favorable neurological function which is defined as Modified Rankin Scale(mRS) score of 0-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Xinfeng Liu, MD study chair
Department of Neurology, Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nerve Growth Factors and normal saline in people with Acute Ischemic Stroke, run by Jinling Hospital, China at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 31 Aug 2021. 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 China. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a favorable neurological function (time frame: at 90 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2021.