Subarachnoid HemorrhagePhase 2ENACT-2NCT02056574
Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms
A Phase 2 study testing NA-1 in people with Subarachnoid Hemorrhage and Ruptured Intracranial Aneurysm, run by NoNO Inc. at 12 sites in 2 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Ruptured Intracranial Aneurysm
- What is being tested?
- NA-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Nov 2015to Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. A diagnosis of a ruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, or any neuroendovascular technique such as balloon-assisted coiling, stenting, or flowed diversion.
- 2. Patient should be Grade II-IV on the WFNS grading scale for SAH.
- 3. Male or female with a minimum age of 18 years on the day of enrolment.
- 4. Female subjects of childbearing potential: Negative pregnancy test.
- 5. Non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing.
- 6. Body weight less than or equal to 180 kg.
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- 7. Vital signs on admission:
- Blood pressure between 80-180 mm Hg systolic/50-100 mm Hg diastolic;
- Body temperature ≤ 38.5C.
- 8. Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements.
Who cannot join
- 1. Prior SAH within 6 months of presentation.
- 2. Dissecting or mycotic brain aneurysm.
- 3. Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
- 4. Known history of life-threatening allergic reaction to any medication.
- 5. Chronic renal disease defined as a baseline serum creatinine > 150 µmol/L.
- 6. Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
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- 7. Women who are breastfeeding.
- 8. Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
- 9. Pre-morbid (estimated) modified Rankin scale score of >1.
- 10. Previous major stroke.
- 11. Patients with known HIV infection.
- 12. Participation in a clinical trial with an investigational drug within 30 days preceding this study.
- 13. Previous participation in the ENACT trial (e.g, to treat a prior aneurysm), participation in another trial involving NA-1 or prior receipt of NA-1.
- 14. Any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 90 days.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada7 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
QEII Health Sciences Centre - Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
London Health Sciences Centre
London, Ontario, N6A 5A5
Hopital de l'Enfant Jesus
Québec, Quebec, G1J 1Z4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
United States5 sites
University of Michigan - Neurosurgery
Ann Arbor, Michigan, 481090000
Colorado Neurological Institute
Englewood, Colorado, 801130000
University of Wisconsin
Madison, Wisconsin, 537920000
Barrow Neurological Institute
Phoenix, Arizona, 850139
Oregon Health and Science University
Portland, Oregon, 97239-3098
About this study
Official title: Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascular Repair of Ruptured Intracranial Aneurysms
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.
- Being tested
- NA-1, Placebo
- Keywords
- Endovascular repair, Subarachnoid hemorrhage, Ruptured intracranial aneurysm, Stroke, Coiling, NA-1
- Medical subject headings
- Subarachnoid Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA-1Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| NA-1 | Experimental | 20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and an 11 amino acid domain that enables the peptide to cross the blood-brain barrier. Single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion. Receives: Drug: NA-1 |
| Placebo | Placebo comparator | Single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.
Measured: 90 days
Secondary outcomes (4)
Modified Rankin Scale (mRS)
Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the mRS at Day 30-45.
Measured: 30-45 days
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 90.
Measured: 90 days
Mortality
Rate of subarachnoid hemorrhage related mortality over the 90 day study period.
Measured: 90 days
In-hospital length of stay
Duration of in-hospital length of stay.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startNov 2015
- Primary completionNov 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NoNO Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Tymianski, MD, PhD, Study director, NoNO Inc.Cameron G McDougall, MD, Principal investigator, Barrow Neurological InstituteMichael D Hill, MD, Principal investigator, Foothills Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056574
- Sponsor's protocol ID
- NA-1-006
- Acronym
- ENACT-2
- Status last verified
- Mar 2015
- First submitted
- 4 Feb 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascular Repair of Ruptured Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT02056574
- Acronym / sponsor ID
- ENACT-2 / NA-1-006
- Keywords
- Endovascular repair, Subarachnoid hemorrhage, Ruptured intracranial aneurysm, Stroke, Coiling, NA-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NoNO Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 6 Feb 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.
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NA-1 | Experimental | Drug: NA-120 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and an 11 amino acid domain that enables the peptide to cross the blood-brain barrier. Single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion. |
| Placebo | Placebo comparator | Drug: PlaceboSingle intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. A diagnosis of a ruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, or any neuroendovascular technique such as balloon-assisted coiling, stenting, or flowed diversion.
- 2. Patient should be Grade II-IV on the WFNS grading scale for SAH.
- 3. Male or female with a minimum age of 18 years on the day of enrolment.
- 4. Female subjects of childbearing potential: Negative pregnancy test.
- 5. Non-surgically sterile males or males with partners of childbearing potential must be willing to use condoms with spermicide for 3 months after completion of dosing.
Key exclusion criteria (14 listed)
- 1. Prior SAH within 6 months of presentation.
- 2. Dissecting or mycotic brain aneurysm.
- 3. Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
- 4. Known history of life-threatening allergic reaction to any medication.
- 5. Chronic renal disease defined as a baseline serum creatinine > 150 µmol/L.
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 |
|---|---|---|
| NA-1 | Drug | NA-1 |
| Placebo | Drug | Placebo |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 90 days
Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90.
4 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: 30-45 days
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 90 days
Mortality
Time frame: 90 days
In-hospital length of stay
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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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.
Michael Tymianski, MD, PhD study director
NoNO Inc.
Cameron G McDougall, MD principal investigator
Barrow Neurological Institute
Michael D Hill, MD principal investigator
Foothills Medical Centre
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NA-1 in people with Subarachnoid Hemorrhage and Ruptured Intracranial Aneurysm, run by NoNO Inc. at 12 sites in 2 countries.
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 14 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: withdrawn, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, United States. 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 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 withdrawn before enrolling participants, so there are no results.
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 Rankin Scale (mRS) (time frame: 90 days). 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 4 Aug 2015.