Motor Weakness in Two or Four LimbsPhase 2NCT02242084
Thrombolysis in Ischemic Spinal Cord Stroke
A Phase 2 study testing Intravenuse Alteplase in people with Motor Weakness in Two or Four Limbs and Damage in the Anterior Spinal Artery (ASA), run by Rabin Medical Center at 1 site in Israel.
Trial summary
Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic events in the central nervous system (CNS). In most cases the consequences are catastrophic, with a high rate of severe functional disability and mortality rate up to 30%. Ischemic stroke of the spinal cord can arise from: 1. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Motor Weakness in Two or Four Limbs, Damage in the Anterior Spinal Artery (ASA), Temperature and Superficial Sensation
- What is being tested?
- Intravenuse Alteplase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to 26 Mar 2019
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with vascular risk factors
- Patients with sudden weakness of the lower or upper limbs together with bowel disorder.
- Window treatment - not over 6 hours since the start of the event till the start of the treatment.
- Patient without dissection of the aorta in the abdomen.
- Patient without contraindication to IVtPA.
- Patient with no etiology found after clarification.
Who cannot join
- 1. Refusal to sign an ICF. 2. Reason for weakness is known. 3. Patient with contraindication IVtPA.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic events in the central nervous system (CNS). In most cases the consequences are catastrophic, with a high rate of severe functional disability and mortality rate up to 30%.
Ischemic stroke of the spinal cord can arise from:
Read more
- Dissection of the aorta.
- Aneurism in the aorta.
- Atherosclerotic disease of the aorta or vertebral arteries.
- Spinal surgeries.
- Spinal AVM.
- Embolism from cardiac origin.
- Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in hours until the patient becomes paralyzed in two or in all four limbs. In most cases the damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor weakness accompanied by disturbance of temperature and superficial sensation, urinary retention or bowel disorder, with preserved position and vibration sense.
The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS). Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the spinal cord is necessary upon arrival in the emergency department.
One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and validated in numerous studies for ischemic events in the brain, until today no validated study in ischemic spinal stroke using thrombolysis has been completed.
- Conditions
- Motor Weakness in Two or Four Limbs, Damage in the Anterior Spinal Artery (ASA), Temperature and Superficial Sensation, Urinary Retention or Bowel Disorder
- Being tested
- Intravenuse Alteplase
- Medical subject headings
- Urinary Retention, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenuse AlteplaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Alteplase treatment | Experimental | All subject who enter the trial will receive treatment with Alteplase along with questionnaire. Receives: Drug: Intravenuse Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ranking Scale (mRS)
Measured: 3 month post thrombolysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startApr 2016
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Weakness in Two or Four LimbsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, israel Steiner, Rabin Medical Center
- Investigators
- Israel Steiner, Professor, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242084
- Sponsor's protocol ID
- AK 23 - 14
- Status last verified
- Mar 2019
- First submitted
- 14 Sep 2014
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombolysis in Ischemic Spinal Cord Stroke
- ClinicalTrials.gov ID
- NCT02242084
- Acronym / sponsor ID
- AK 23 - 14
- Conditions
- Motor Weakness in Two or Four Limbs, Damage in the Anterior Spinal Artery (ASA), Temperature and Superficial Sensation, Urinary Retention or Bowel Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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.
Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic events in the central nervous system (CNS). In most cases the consequences are catastrophic, with a high rate of severe functional disability and mortality rate up to 30%.
Ischemic stroke of the spinal cord can arise from:
- Dissection of the aorta.
- Aneurism in the aorta.
- Atherosclerotic disease of the aorta or vertebral arteries.
- Spinal surgeries.
- Spinal AVM.
- Embolism from cardiac origin.
- Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in hours until the patient becomes paralyzed in two or in all four limbs. In most cases the damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor weakness accompanied by disturbance of temperature and superficial sensation, urinary retention or bowel disorder, with preserved position and vibration sense.
The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS). Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the spinal cord is necessary upon arrival in the emergency department.
One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and validated in numerous studies for ischemic events in the brain, until today no validated study in ischemic spinal stroke using thrombolysis has been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alteplase treatment | Experimental | Drug: Intravenuse AlteplaseAll subject who enter the trial will receive treatment with Alteplase along with questionnaire. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with vascular risk factors
- Patients with sudden weakness of the lower or upper limbs together with bowel disorder.
- Window treatment - not over 6 hours since the start of the event till the start of the treatment.
- Patient without dissection of the aorta in the abdomen.
- Patient without contraindication to IVtPA.
Key exclusion criteria (2 listed)
- 1. Refusal to sign an ICF. 2. Reason for weakness is known. 3. Patient with contraindication IVtPA.
- -
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 |
|---|---|---|
| Intravenuse Alteplase | Drug | Alteplase treatment |
Primary outcome
Modified Ranking Scale (mRS)
Time frame: 3 month post thrombolysis
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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.
Israel Steiner, Professor principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenuse Alteplase in people with Motor Weakness in Two or Four Limbs and Damage in the Anterior Spinal Artery (ASA), run by Rabin Medical Center at 1 site in Israel.
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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 28 Mar 2019. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Modified Ranking Scale (mRS) (time frame: 3 month post thrombolysis). 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 28 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.