Brain ConcussionNCT04499937
ReCoUPS: Post-Concussion Patient Reports
A study testing Streak incentive and Loss-based incentive in people with Brain Concussion and Head Injury, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
Physical and cognitive rest are recommended as treatment for concussion, but debate persists about the utility of this recommendation for patients recovering from concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. Read more about this study
- Who is it for?
- Ages 13 to 64 years
- Conditions the study is for
- Brain Concussion, Head Injury
- What is being tested?
- Streak incentive and Loss-based incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2019to 5 Feb 2021
- Phase
- Interventional
- 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 13 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females ages 13 to 64 years.
- Presents with head injury concerning for concussion in line with criteria specified in the most recent Consensus Statement on Concussion in Sport, defined as head trauma with neurologic impairment, including, but not limited to somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or emotional symptoms (eg, lability) symptoms.
- Within approximately 5 days of injury.
- Ownership of a smartphone to report symptoms and activities.
- Speak English.
- Informed consent or parental/guardian permission and child assent for those under 18 years of age.
Who cannot join
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: ReCoUPS: Incentive-Based and Real-Time Symptom and Activity Reporting After Concussion
Physical and cognitive rest are recommended as treatment for concussion, but debate persists about the utility of this recommendation for patients recovering from concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. This study will measure and compare symptom and activity reports in the days and weeks after a concussion among patients randomly assigned to different incentive-based arms.
Read the detailed description
Although physical and cognitive rest are recommended as the hallmark treatment for concussion, debate persists about the utility of this recommendation for patients recovering from a concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. Objective and timely measures of physical and cognitive activity will aid in defining the relationship between physical and cognitive rest and clinical outcomes, such as symptom status, in the days and weeks after a concussion. Random assignment to incentive-based arms will be used to measure patient engagement with the study protocol and a dedicated research platform that involves ecological momentary assessment (EMA), in which participants report their real-time symptoms and daily activities in response to randomly timed prompts, will be used to help assess the rest and recovery process among pediatric and adult patients after concussion.
- Conditions
- Brain Concussion, Head Injury
- Being tested
- Streak incentive, Loss-based incentive, Flat-fee control status quo condition, Flat-Fitbit control status quo condition
- Medical subject headings
- Brain Concussion, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streak incentiveBehavioural
Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with a $0 balance and will earn a fixed amount for each response.
Loss-based incentiveBehavioural
Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with the maximum balance and will lose a fixed amount for each response they do not complete.
Flat-fee control status quo conditionBehavioural
Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will receive the maximum compensation at the end of the study.
Flat-Fitbit control status quo conditionBehavioural
Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will keep the Fitbit at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Streak incentive | Experimental | Subjects start with no money in an account, but they earn a fixed amount with each response. In this arm, each adult report is worth $3.17 so an adult subject can earn up to $200 if he/she responds to all surveys. If an adult completes at least 75% of the reports, he/she will receive an $100 bonus for a total maximum of $300. In this arm, each child report is worth 0.52 cents so a child subject can earn up to $33 if he/she responds to all surveys. If a child completes at least 75% of the reports, he/she will receive a $17 bonus for a total maximum of $50. Receives: Behavioral: Streak incentive |
| Loss-based incentive | Experimental | Subjects start with the maximum possible compensation, but money is deducted for each missed response. Adult subjects will lose $4.76 for each missed survey. Child subjects will lose $0.79 for each missed survey. Receives: Behavioral: Loss-based incentive |
| Flat-fee control status quo condition | Active comparator | Subjects will receive the maximum possible compensation at the end of the study regardless of response rate. Receives: Behavioral: Flat-fee control status quo condition |
| Flat-Fitbit control status quo condition | Active comparator | Subjects will be compensated by keeping the Fitbit at the end of the study regardless of response rate. Receives: Behavioral: Flat-Fitbit control status quo condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant adherence to completing daily survey
This is a study where each participant is sent a short survey (PCSI instrument) three times each day for 21 days. The participant is instructed to reply to each survey within several minutes of receiving the prompt. We are interested in the extent to which participants will adhere to this instruction. Therefore, the outcome of interest is whether or not the participant replied to a given survey prompt. When we evaluate patient adherence in the data, we do this by calculating the % of survey prompts to which a given participant responded. In sum, the outcome is adherence to the survey.
Measured: 21 days
Secondary outcomes (5)
Time to recovery
Assess and quantify the concussion recovery process by monitoring symptoms and cognitive and physical activity on a daily basis.
Measured: 1 to 21 days
Correlation between symptoms and physical activity
Determine if there is a correlation each day between the daily symptom score from the PCSI (0-126) and the number of hours spent exercising (physical activity).
Measured: 1-21 days
Patient-reported activity vs. objective measures of activity
Compare the patient-reported hours spent exercising on a given day to the patient's daily step count collected through Fitbit on that same day.
Measured: 1-21 days
Test Way to Health platform
Test Way to Health as a platform for efficiently randomizing and monitoring patients
Measured: 1-21 days
Correlation between symptoms and cognitive activity
Determine if there is a correlation each day between the daily symptom score from the PCSI (0-126) and the number of hours participants spent doing homework, napping, and using screens combined (cognitive activity).
Measured: 1-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start3 Mar 2019
- Primary completion31 Dec 2020
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Douglas Wiebe, PhD, Principal investigator, University of PennsylvaniaDaniel Corwin, MD, Principal investigator, Children's Hospital of PhiladelphiaChristina Master, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499937
- Sponsor's protocol ID
- 16-013326
- Status last verified
- Mar 2024
- First submitted
- 20 Jul 2020
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korley FK, Kelen GD, Jones CM, Diaz-Arrastia R. Emergency Department Evaluation of Traumatic Brain Injury in the United States, 2009-2010. J Head Trauma Rehabil. 2016 Nov/Dec;31(6):379-387. doi: 10.1097/HTR.0000000000000187.
PubMed 26360006McCrea M, Guskiewicz KM, Marshall SW, Barr W, Randolph C, Cantu RC, Onate JA, Yang J, Kelly JP. Acute effects and recovery time following concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2556-63. doi: 10.1001/jama.290.19.2556.
PubMed 14625332Leddy JJ, Baker JG, Kozlowski K, Bisson L, Willer B. Reliability of a graded exercise test for assessing recovery from concussion. Clin J Sport Med. 2011 Mar;21(2):89-94. doi: 10.1097/JSM.0b013e3181fdc721.
PubMed 21358497Brown NJ, Mannix RC, O'Brien MJ, Gostine D, Collins MW, Meehan WP 3rd. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics. 2014 Feb;133(2):e299-304. doi: 10.1542/peds.2013-2125. Epub 2014 Jan 6.
PubMed 24394679McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med. 2013 Apr;47(5):250-8. doi: 10.1136/bjsports-2013-092313. No abstract available.
PubMed 23479479Moor HM, Eisenhauer RC, Killian KD, Proudfoot N, Henriques AA, Congeni JA, Reneker JC. The relationship between adherence behaviors and recovery time in adolescents after a sports-related concussion: an observational study. Int J Sports Phys Ther. 2015 Apr;10(2):225-33.
PubMed 25883871Meehan WP 3rd, Bachur RG. The recommendation for rest following acute concussion. Pediatrics. 2015 Feb;135(2):362-3. doi: 10.1542/peds.2014-3665. Epub 2015 Jan 5. No abstract available.
PubMed 25560439Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):213-23. doi: 10.1542/peds.2014-0966. Epub 2015 Jan 5.
PubMed 25560444Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.
PubMed 23479489Wiebe DJ, Nance ML, Houseknecht E, Grady MF, Otto N, Sandsmark DK, Master CL. Ecologic Momentary Assessment to Accomplish Real-Time Capture of Symptom Progression and the Physical and Cognitive Activities of Patients Daily Following Concussion. JAMA Pediatr. 2016 Nov 1;170(11):1108-1110. doi: 10.1001/jamapediatrics.2016.1979. No abstract available.
PubMed 27617669Corwin DJ, Orchinik J, D'Alonzo B, Agarwal AK, Pettijohn KW, Master CL, Wiebe DJ. A Randomized Trial of Incentivization to Maximize Retention for Real-Time Symptom and Activity Monitoring Using Ecological Momentary Assessment in Pediatric Concussion. Pediatr Emerg Care. 2023 Jul 1;39(7):488-494. doi: 10.1097/PEC.0000000000002870. Epub 2022 Nov 3.
PubMed 36730797
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReCoUPS: Incentive-Based and Real-Time Symptom and Activity Reporting After Concussion
- ClinicalTrials.gov ID
- NCT04499937
- Acronym / sponsor ID
- 16-013326
- Conditions
- Brain Concussion, Head Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 5 Aug 2020 (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.
Physical and cognitive rest are recommended as treatment for concussion, but debate persists about the utility of this recommendation for patients recovering from concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. This study will measure and compare symptom and activity reports in the days and weeks after a concussion among patients randomly assigned to different incentive-based arms.
Detailed description
Although physical and cognitive rest are recommended as the hallmark treatment for concussion, debate persists about the utility of this recommendation for patients recovering from a concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. Objective and timely measures of physical and cognitive activity will aid in defining the relationship between physical and cognitive rest and clinical outcomes, such as symptom status, in the days and weeks after a concussion. Random assignment to incentive-based arms will be used to measure patient engagement with the study protocol and a dedicated research platform that involves ecological momentary assessment (EMA), in which participants report their real-time symptoms and daily activities in response to randomly timed prompts, will be used to help assess the rest and recovery process among pediatric and adult patients after concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Streak incentive | Experimental | Behavioral: Streak incentiveSubjects start with no money in an account, but they earn a fixed amount with each response. In this arm, each adult report is worth $3.17 so an adult subject can earn up to $200 if he/she responds to all surveys. If an adult completes at least 75% of the reports, he/she will receive an $100 bonus for a total maximum of $300. In this arm, each child report is worth 0.52 cents so a child subject can earn up to $33 if he/she responds to all surveys. If a child completes at least 75% of the reports, he/she will receive a $17 bonus for a total maximum of $50. |
| Loss-based incentive | Experimental | Behavioral: Loss-based incentiveSubjects start with the maximum possible compensation, but money is deducted for each missed response. Adult subjects will lose $4.76 for each missed survey. Child subjects will lose $0.79 for each missed survey. |
| Flat-fee control status quo condition | Active comparator | Behavioral: Flat-fee control status quo conditionSubjects will receive the maximum possible compensation at the end of the study regardless of response rate. |
| Flat-Fitbit control status quo condition | Active comparator | Behavioral: Flat-Fitbit control status quo conditionSubjects will be compensated by keeping the Fitbit at the end of the study regardless of response rate. |
Who may qualify
- Ages
- 13 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males or females ages 13 to 64 years.
- Presents with head injury concerning for concussion in line with criteria specified in the most recent Consensus Statement on Concussion in Sport, defined as head trauma with neurologic impairment, including, but not limited to somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or emotional symptoms (eg, lability) symptoms.
- Within approximately 5 days of injury.
- Ownership of a smartphone to report symptoms and activities.
- Speak English.
Key exclusion criteria (1 listed)
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
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 |
|---|---|---|
| Streak incentiveParticipants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with a $0 balance and will earn a fixed amount for each response. | Behavioural | Streak incentive |
| Loss-based incentiveParticipants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with the maximum balance and will lose a fixed amount for each response they do not complete. | Behavioural | Loss-based incentive |
| Flat-fee control status quo conditionParticipants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will receive the maximum compensation at the end of the study. | Behavioural | Flat-fee control status quo condition |
| Flat-Fitbit control status quo conditionParticipants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will keep the Fitbit at the end of the study. | Behavioural | Flat-Fitbit control status quo condition |
Primary outcome
Participant adherence to completing daily survey
Time frame: 21 days
This is a study where each participant is sent a short survey (PCSI instrument) three times each day for 21 days. The participant is instructed to reply to each survey within several minutes of receiving the prompt. We are interested in the extent to which participants will adhere to this instruction. Therefore, the outcome of interest is whether or not the participant replied to a given survey prompt. When we evaluate patient adherence in the data, we do this by calculating the % of survey prompts to which a given participant responded. In sum, the outcome is adherence to the survey.
5 secondary outcomes
Time to recovery
Time frame: 1 to 21 days
Correlation between symptoms and physical activity
Time frame: 1-21 days
Patient-reported activity vs. objective measures of activity
Time frame: 1-21 days
Test Way to Health platform
Time frame: 1-21 days
Correlation between symptoms and cognitive activity
Time frame: 1-21 days
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 8 Mar 2024.
- Background: PubMed 26360006Korley FK, Kelen GD, Jones CM, Diaz-Arrastia R. Emergency Department Evaluation of Traumatic Brain Injury in the United States, 2009-2010. J Head Trauma Rehabil. 2016 Nov/Dec;31(6):379-387. doi: 10.1097/HTR.0000000000000187.
- Background: PubMed 14625332McCrea M, Guskiewicz KM, Marshall SW, Barr W, Randolph C, Cantu RC, Onate JA, Yang J, Kelly JP. Acute effects and recovery time following concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2556-63. doi: 10.1001/jama.290.19.2556.
- Background: PubMed 21358497Leddy JJ, Baker JG, Kozlowski K, Bisson L, Willer B. Reliability of a graded exercise test for assessing recovery from concussion. Clin J Sport Med. 2011 Mar;21(2):89-94. doi: 10.1097/JSM.0b013e3181fdc721.
- Background: PubMed 24394679Brown NJ, Mannix RC, O'Brien MJ, Gostine D, Collins MW, Meehan WP 3rd. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics. 2014 Feb;133(2):e299-304. doi: 10.1542/peds.2013-2125. Epub 2014 Jan 6.
- Background: PubMed 23479479McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med. 2013 Apr;47(5):250-8. doi: 10.1136/bjsports-2013-092313. No abstract available.
- Background: PubMed 25883871Moor HM, Eisenhauer RC, Killian KD, Proudfoot N, Henriques AA, Congeni JA, Reneker JC. The relationship between adherence behaviors and recovery time in adolescents after a sports-related concussion: an observational study. Int J Sports Phys Ther. 2015 Apr;10(2):225-33.
- Background: PubMed 25560439Meehan WP 3rd, Bachur RG. The recommendation for rest following acute concussion. Pediatrics. 2015 Feb;135(2):362-3. doi: 10.1542/peds.2014-3665. Epub 2015 Jan 5. No abstract available.
- Background: PubMed 25560444Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):213-23. doi: 10.1542/peds.2014-0966. Epub 2015 Jan 5.
- Background: PubMed 23479489Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.
- Background: PubMed 27617669Wiebe DJ, Nance ML, Houseknecht E, Grady MF, Otto N, Sandsmark DK, Master CL. Ecologic Momentary Assessment to Accomplish Real-Time Capture of Symptom Progression and the Physical and Cognitive Activities of Patients Daily Following Concussion. JAMA Pediatr. 2016 Nov 1;170(11):1108-1110. doi: 10.1001/jamapediatrics.2016.1979. No abstract available.
- Derived from this study: PubMed 36730797Corwin DJ, Orchinik J, D'Alonzo B, Agarwal AK, Pettijohn KW, Master CL, Wiebe DJ. A Randomized Trial of Incentivization to Maximize Retention for Real-Time Symptom and Activity Monitoring Using Ecological Momentary Assessment in Pediatric Concussion. Pediatr Emerg Care. 2023 Jul 1;39(7):488-494. doi: 10.1097/PEC.0000000000002870. Epub 2022 Nov 3.
- 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.
Douglas Wiebe, PhD principal investigator
University of Pennsylvania
Daniel Corwin, MD principal investigator
Children's Hospital of Philadelphia
Christina Master, MD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streak incentive and Loss-based incentive in people with Brain Concussion and Head Injury, run by Children's Hospital of Philadelphia at 2 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 6 inclusion and 1 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 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Participant adherence to completing daily survey (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04499937, which also lists 11 linked publications.
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 8 Mar 2024.