Brain InjuriesPhase 2INTREPID2566NCT01366820
Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC
A Phase 2 study testing NNZ-2566 in people with Brain Injuries, run by Neuren Pharmaceuticals Limited at 6 sites in United States.
Trial summary
The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI). Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- NNZ-2566
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2013to Jan 2016
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-penetrating TBI.
- Age 16-75 years.
- Admission to hospital.
- Post resuscitation GCS 4-12.
- Have at least one reactive pupil.
- Able to receive investigational product within 8 hours of injury.
- Hemodynamically stable after resuscitation (systolic blood pressure (SBP) >100 mm Hg).
- Able to read and write English and have sufficient motor dexterity prior to injury to undertake the neuropsychological and activities of daily living (ADL) testing, in the opinion of the investigator, at 1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks) post injury.
Who cannot join
- Penetrating brain injury.
- Spinal cord injury.
- Presence or known history of prior cerebral injury requiring hospitalization that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
- Non-traumatic brain injury.
- Known history of any medical or psychiatric disorder, or any severe concomitant disease that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
- Significant non-central nervous system (CNS) injuries sustained at the time of the TBI would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
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- Weight >150 kg.
- Participation in another clinical trial within the previous 4 weeks.
- Clinical state requiring greater than 6 L blood, colloid or crystalloid fluid resuscitation prior to randomization.
- Pregnant or nursing mothers. Women of child-bearing potential must have a negative urine or blood test prior to randomization.
- Prior enrollment in this study.
- QTc Exclusions. The study will use the exclusion criteria as defined in ICH Guideline E14 to exclude patients with a risk of QT/QTc prolongation, as follows:
- A marked baseline prolongation of corrected QT/QTc interval >450 ms.
- History of risk factors for torsade de pointes (e.g. heart failure, hypokalemia (serum potassium at screening <3.0 mmol/L)or family history of long QT syndrome).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Arrowhead Regional Medical Center
Colton, California, 92324
Detroit Receiving Hospital and University Health Center
Detroit, Michigan, 48201
Sinai Grace Hospital
Detroit, Michigan, 48235
The Queen's Medical Center
Honolulu, Hawaii, 96813
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study of NNZ-2566 in Patients With Traumatic Brain Injury (TBI) Conducted Under an Exception From Informed Consent (EFIC)
The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).
Read the detailed description
Moderate to severe traumatic brain injury frequently results in persistent problems with memory, attention span, mood and more complex brain functioning such as planning and organizing. There are currently no drugs available to reduce the brain damage or the persisting symptoms that result from TBI. The longer term goal of this study is to provide physicians with a safe and effective treatment for TBI
- Conditions
- Brain Injuries
- Being tested
- NNZ-2566, Placebo
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNZ-2566Drug
Also called Glycyl-L-2-Methylprolyl-L-Glutamic Acid
Solution for intravenous infusion.
Intravenous bolus infusion over 10 minutes followed by a continuous intravenous maintenance infusion for a total of 72 consecutive hours.
PlaceboDrug
Also called Sodium Chloride 0.9% Injection
Sodium Chloride 0.9% Injection
| Study group | Role | What they receive |
|---|---|---|
| NNZ-2566 | Experimental | 20 mg/kg intravenous bolus infusion of NNZ-2566 over 10 minutes followed by a continuous intravenous infusion of 6 mg/kg/h (n=133) intravenous infusion of NNZ-2566 for a total of 72 consecutive hours. Receives: Drug: NNZ-2566 |
| Sodium Chloride (0.9%) for Injection | Placebo comparator | Intravenous bolus infusion of Sodium Chloride (0.9%) for Injection over 10 minutes followed by a continuous intravenous infusion of Sodium Chloride (0.9%) for Injection for a total of 72 consecutive hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced incidence, compared to placebo, of adverse events (AEs) and serious adverse events (SAEs)
Measured: AEs to discharged or Day 30 post randomization, whichever occurs first, and SAEs through to 3 months (defined as 12-14 weeks), post randomization.
Secondary outcomes (4)
Evidence of efficacy in modifying global outcomes by evaluating Glasgow Outcome Scale - Extended (GOS-E) and activities of daily living (Mayo-Portland Adaptability Inventory - 4th Edition (MPAI-4))
Measured: 1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks), post randomization.
Improvement in cognitive and neuropsychological functioning.
Measured: 1 month (defined as 4-6 weeks) and at 3 months (defined as 12-14 weeks), post randomization.
Modification of the acute physiological processes in TBI by evaluating electroencephalographic (EEG) determinants in patients with moderate to severe TBI (defined as GCS 4-12), and biomarker levels.
Measured: Baseline through to 72 hours post-start of infusion.
Blood pharmacokinetics (PK) of an intravenous (i.v) dose of NNZ-2566 when administered as a 10-minute infusion immediately followed by a 72-hour infusion.
Measured: Start of infusion through to 12 hours post infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startFeb 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuren Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ross R Bullock, M.D., PhD, Principal investigator, University of Miami, Lois Pope Life Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366820
- Sponsor's protocol ID
- Neu-2566-TBI-002
- Acronym
- INTREPID2566
- Status last verified
- Feb 2018
- First submitted
- 29 May 2011
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Study of NNZ-2566 in Patients With Traumatic Brain Injury (TBI) Conducted Under an Exception From Informed Consent (EFIC)
- ClinicalTrials.gov ID
- NCT01366820
- Acronym / sponsor ID
- INTREPID2566 / Neu-2566-TBI-002
- Conditions
- Brain Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Neuren Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Jun 2011 (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.
The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).
Detailed description
Moderate to severe traumatic brain injury frequently results in persistent problems with memory, attention span, mood and more complex brain functioning such as planning and organizing. There are currently no drugs available to reduce the brain damage or the persisting symptoms that result from TBI. The longer term goal of this study is to provide physicians with a safe and effective treatment for TBI
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 |
|---|---|---|
| NNZ-2566 | Experimental | Drug: NNZ-256620 mg/kg intravenous bolus infusion of NNZ-2566 over 10 minutes followed by a continuous intravenous infusion of 6 mg/kg/h (n=133) intravenous infusion of NNZ-2566 for a total of 72 consecutive hours. |
| Sodium Chloride (0.9%) for Injection | Placebo comparator | Drug: PlaceboIntravenous bolus infusion of Sodium Chloride (0.9%) for Injection over 10 minutes followed by a continuous intravenous infusion of Sodium Chloride (0.9%) for Injection for a total of 72 consecutive hours. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Non-penetrating TBI.
- Age 16-75 years.
- Admission to hospital.
- Post resuscitation GCS 4-12.
- Have at least one reactive pupil.
Key exclusion criteria (14 listed)
- Penetrating brain injury.
- Spinal cord injury.
- Presence or known history of prior cerebral injury requiring hospitalization that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
- Non-traumatic brain injury.
- Known history of any medical or psychiatric disorder, or any severe concomitant disease that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
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 |
|---|---|---|
| NNZ-2566Also: Glycyl-L-2-Methylprolyl-L-Glutamic AcidSolution for intravenous infusion. Intravenous bolus infusion over 10 minutes followed by a continuous intravenous maintenance infusion for a total of 72 consecutive hours. | Drug | NNZ-2566 |
| PlaceboAlso: Sodium Chloride 0.9% InjectionSodium Chloride 0.9% Injection | Drug | Sodium Chloride (0.9%) for Injection |
Primary outcome
Reduced incidence, compared to placebo, of adverse events (AEs) and serious adverse events (SAEs)
Time frame: AEs to discharged or Day 30 post randomization, whichever occurs first, and SAEs through to 3 months (defined as 12-14 weeks), post randomization.
4 secondary outcomes
Evidence of efficacy in modifying global outcomes by evaluating Glasgow Outcome Scale - Extended (GOS-E) and activities of daily living (Mayo-Portland Adaptability Inventory - 4th Edition (MPAI-4))
Time frame: 1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks), post randomization.
Improvement in cognitive and neuropsychological functioning.
Time frame: 1 month (defined as 4-6 weeks) and at 3 months (defined as 12-14 weeks), post randomization.
Modification of the acute physiological processes in TBI by evaluating electroencephalographic (EEG) determinants in patients with moderate to severe TBI (defined as GCS 4-12), and biomarker levels.
Time frame: Baseline through to 72 hours post-start of infusion.
Blood pharmacokinetics (PK) of an intravenous (i.v) dose of NNZ-2566 when administered as a 10-minute infusion immediately followed by a 72-hour infusion.
Time frame: Start of infusion through to 12 hours post infusion.
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 5 Feb 2018.
- 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.
Ross R Bullock, M.D., PhD principal investigator
University of Miami, Lois Pope Life Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNZ-2566 in people with Brain Injuries, run by Neuren Pharmaceuticals Limited at 6 sites in United States.
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 8 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: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in 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 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?
Reduced incidence, compared to placebo, of adverse events (AEs) and serious adverse events (SAEs) (time frame: AEs to discharged or Day 30 post randomization, whichever occurs first, and SAEs through to 3 months (defined as 12-14 weeks), post randomization.). 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 5 Feb 2018.