Traumatic Brain InjuryPhase 1NCT01815125
Ondansetron for Pediatric Mild Traumatic Brain Injury
A Phase 1 study testing Ondansetron in people with Traumatic Brain Injury and Brain Concussion, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present persistent symptoms at one week post injury. A systematic review showed a paucity of studies for short term outcomes following mTBI. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Traumatic Brain Injury, Brain Concussion
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Feb 2014
- Phase
- Phase 1
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 8 and 17 years old. This will be limited to this small spectrum of age to insure better homogeneity in the evaluation of the participants and streamlining of outcome measures. Also, this is the age group for which our measurement tool has been validated.
- Occurrence of a mTBI as defined by the presence of a head trauma, a Glasgow coma scale of 13 to 15 and at least one of the three following criteria4 :
- Any period of loss of consciousness.
- Any loss of memory for events immediately before or after the accident.
- Any alteration in mental state at the time of the accident (eg, feeling dazed, disoriented).
- And the absence of the following criteria:
Show all 9Show fewer
- Post-traumatic amnesia greater than 24 hours.
- Glasgow Coma Scale < 13, 30 minutes post accident.
- The trauma occurred in the preceding 24 hours.
Who cannot join
- 1. Inability to obtain a proper written informed consent (language barrier, absence of a parental authority, developmental delay, intoxication, patient too confuse to consent according to the treating physician).
- 2. Known allergic reaction or intolerance to ondansetron. 3. Known rhythm or cardiac problem, or history of sudden death in the proximal family 4. Patients who are taking a medication which could increase the QT interval. 5. Patients who received ondansetron in the previous 24 hours 6. Any abnormality on radiological studies, including any bleeding in the brain or skull fracture.
- 7. Multi-system injuries with treatment requiring admission to hospital or procedural sedation in the ED.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ondansetron for Pediatric Mild Traumatic Brain Injury; a Pilot Randomized Controlled Trial.
Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present persistent symptoms at one week post injury. A systematic review showed a paucity of studies for short term outcomes following mTBI. Among potential treatments for mTBI, ondansetron has shown promising results based on clinical experience and a single retrospective study. Objectives: The primary objective of this pilot study is to determine the feasibility of a randomized controlled trial evaluating the effect of ondansetron to decrease post concussion symptoms at one week following mTBI in children. More specifically, this pilot study will evaluate the proportion of participants who complete assessment at one week following intervention. Method: This will be a randomized, double blinded, controlled trial performed among children aged between 8 and 17 years old who sustained a mTBI in the previous 24 hours. Participants visiting the emergency department will be randomized to receive one dose of either ondansetron or placebo. The primary outcome of interest is defined as an increase from pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom Inventory (PCSI) one week following trauma. Secondary outcomes will include time to full recovery, mean PCSI score, and outcomes at one month following head trauma. The primary analysis will compare the proportion of participants with persistence of symptoms at one week in both groups. The full study sample size was calculated to have 90% power to detect a decrease in the proportion of persistence of symptoms from 50% to 30% with an alpha value of 0.05. Approximately 126 patients will therefore be recruited in each arm. The investigators plan to recruit 30 participants (10% of the final population) for the pilot study. Expected results: This pilot study should confirm the feasibility of the randomized controlled trial by showing that 90% of the recruited participants provide data on the primary outcome at one week following intervention. On the long term, the investigator expect that ondansetron will decrease the proportion of patients sustaining persistent symptoms of concussion from 50% to lower than 30%.
- Conditions
- Traumatic Brain Injury, Brain Concussion
- Being tested
- Ondansetron, PLacebo
- Keywords
- Mild traumatic brain injury, Brain concussion, Post-concussion syndrome, Emergency department, Ondansetron
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Post-Concussion Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
The intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg.
PLaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | The intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg. Receives: Drug: Ondansetron |
| Placebo | Placebo comparator | The control group will receive a similar looking/ tasting pill of placebo. Receives: Drug: PLacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of post concussive symptoms
Persistence of post concussive symptoms will be defined by an increase from pre-concussion baseline of at least 3 symptoms of the Post Concussion Symptom Inventory (PCSI). The PCSI is a self-report tool evaluating the presence of 25 symptoms (on a 3-point likert scale) for children 8-12 and 26 symptoms on a (7-point likert scale) for children 13-17 years. An increase of two points or more from pre-injury in any symptom is considered clinically significant.
Measured: 1 week post intervention
Secondary outcomes (6)
Mean number of PCSI symptoms
Measured: one week and month following intervention
Mean number of school days missed
Measured: one month following intervention
Number of days of sport activity restriction
Measured: 1 month following intervention
Time before full recovery
According to the parents
Measured: One month following intervention
Healthcare utilization
Proportion of participants who consulted a health resource.
Measured: One month following intervention
Side effects
Side effects will include, in addition to symptoms related to mTBI,proportion of participants who complained of diarrhea or constipation (binary answer).
Measured: one week and month following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Gravel, St. Justine's Hospital
- Investigators
- Jocelyn Gravel, MD, Principal investigator, CHU Sainte-JUstine, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815125
- Sponsor's protocol ID
- ZOF2013
- Other IDs
- 9427-c2686-28c
- Status last verified
- Feb 2014
- First submitted
- 18 Mar 2013
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron for Pediatric Mild Traumatic Brain Injury; a Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01815125
- Acronym / sponsor ID
- ZOF2013
- Conditions
- Traumatic Brain Injury, Brain Concussion
- Keywords
- Mild traumatic brain injury, Brain concussion, Post-concussion syndrome, Emergency department, Ondansetron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Mar 2013 (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.
Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present persistent symptoms at one week post injury. A systematic review showed a paucity of studies for short term outcomes following mTBI. Among potential treatments for mTBI, ondansetron has shown promising results based on clinical experience and a single retrospective study. Objectives: The primary objective of this pilot study is to determine the feasibility of a randomized controlled trial evaluating the effect of ondansetron to decrease post concussion symptoms at one week following mTBI in children. More specifically, this pilot study will evaluate the proportion of participants who complete assessment at one week following intervention. Method: This will be a randomized, double blinded, controlled trial performed among children aged between 8 and 17 years old who sustained a mTBI in the previous 24 hours. Participants visiting the emergency department will be randomized to receive one dose of either ondansetron or placebo. The primary outcome of interest is defined as an increase from pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom Inventory (PCSI) one week following trauma. Secondary outcomes will include time to full recovery, mean PCSI score, and outcomes at one month following head trauma. The primary analysis will compare the proportion of participants with persistence of symptoms at one week in both groups. The full study sample size was calculated to have 90% power to detect a decrease in the proportion of persistence of symptoms from 50% to 30% with an alpha value of 0.05. Approximately 126 patients will therefore be recruited in each arm. The investigators plan to recruit 30 participants (10% of the final population) for the pilot study. Expected results: This pilot study should confirm the feasibility of the randomized controlled trial by showing that 90% of the recruited participants provide data on the primary outcome at one week following intervention. On the long term, the investigator expect that ondansetron will decrease the proportion of patients sustaining persistent symptoms of concussion from 50% to lower than 30%.
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 |
|---|---|---|
| Ondansetron | Experimental | Drug: OndansetronThe intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg. |
| Placebo | Placebo comparator | Drug: PLaceboThe control group will receive a similar looking/ tasting pill of placebo. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged between 8 and 17 years old. This will be limited to this small spectrum of age to insure better homogeneity in the evaluation of the participants and streamlining of outcome measures. Also, this is the age group for which our measurement tool has been validated.
- Occurrence of a mTBI as defined by the presence of a head trauma, a Glasgow coma scale of 13 to 15 and at least one of the three following criteria4 :
- The trauma occurred in the preceding 24 hours.
Key exclusion criteria (3 listed)
- 1. Inability to obtain a proper written informed consent (language barrier, absence of a parental authority, developmental delay, intoxication, patient too confuse to consent according to the treating physician).
- 2. Known allergic reaction or intolerance to ondansetron. 3. Known rhythm or cardiac problem, or history of sudden death in the proximal family 4. Patients who are taking a medication which could increase the QT interval. 5. Patients who received ondansetron in the previous 24 hours 6. Any abnormality on radiological studies, including any bleeding in the brain or skull fracture.
- 7. Multi-system injuries with treatment requiring admission to hospital or procedural sedation in the ED.
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 |
|---|---|---|
| OndansetronAlso: ZofranThe intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg. | Drug | Ondansetron |
| PLaceboplacebo | Drug | Placebo |
Primary outcome
Persistence of post concussive symptoms
Time frame: 1 week post intervention
Persistence of post concussive symptoms will be defined by an increase from pre-concussion baseline of at least 3 symptoms of the Post Concussion Symptom Inventory (PCSI). The PCSI is a self-report tool evaluating the presence of 25 symptoms (on a 3-point likert scale) for children 8-12 and 26 symptoms on a (7-point likert scale) for children 13-17 years. An increase of two points or more from pre-injury in any symptom is considered clinically significant.
6 secondary outcomes
Mean number of PCSI symptoms
Time frame: one week and month following intervention
Mean number of school days missed
Time frame: one month following intervention
Number of days of sport activity restriction
Time frame: 1 month following intervention
Time before full recovery
Time frame: One month following intervention
Healthcare utilization
Time frame: One month following intervention
Side effects
Time frame: one week and month following intervention
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 29 Sep 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.
Jocelyn Gravel, MD principal investigator
CHU Sainte-JUstine, University of Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ondansetron in people with Traumatic Brain Injury and Brain Concussion, run by St. Justine's Hospital at 1 site in Canada.
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 9 inclusion and 3 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 29 Sep 2015. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Persistence of post concussive symptoms (time frame: 1 week post intervention). 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 29 Sep 2015.