StrokeNCT02817087
Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke
A study testing repetitive Transcranial Magnetic Stimulation -On and repetitive Transcranial Magnetic Stimulation -Off in people with Stroke, run by David Chiu, MD at 1 site in United States.
Trial summary
Transcranial magnetic stimulation for post-stroke upper-body motor deficits. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- repetitive Transcranial Magnetic Stimulation -On and repetitive Transcranial Magnetic Stimulation -Off
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2016to 13 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years;
- Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; --
Who cannot join
- History of seizure;
- Epileptogenic activity (indicative of increased risk of seizures) on EEG;
- Any active unstable medical condition;
- Pregnancy;
- Schizophrenia, bipolar disorder, alcoholism, or substance abuse;
- Medications which in the investigator's clinical judgment significantly lower the seizure threshold;
Show all 14Show fewer
- Presence of metal or electronic implants in the head (or any in the body that preclude MRI) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.;
- Any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study.
- Botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study
- Changes in NIHSS and motor assessment scores between Visit 1 and Visit 2 indicating that the patient's impairment is not stable. The following cutoffs, based on research establishing Clinically Important Differences, will be used for this determination:
- National Institutes of Health Stroke Scale: A change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction.
- Fugl-Meyer Assessment of Sensorimotor Impairment: A change of more than 5 points in either direction on the upper-extremity motor score for the affected arm.
- Action Research Arm Test: A change of more than 5 points in either direction on the ARAT score for the affected arm.
- Any condition that precludes a high quality brain MRI scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.
Read the detailed description
This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved.
This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.
- Conditions
- Stroke
- Being tested
- repetitive Transcranial Magnetic Stimulation -On, repetitive Transcranial Magnetic Stimulation -Off
- Keywords
- Stroke, chronic ischemic stroke, cerebrovascular accident (CVA), ischaemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic Stimulation -OnDevice
Also called transcranial magnetic stimulation (TMS), Transcranial Rotating Permanent Magnet Stimulation (TRPMS), repetitive Transcranial Magnetic Stimulation (rTMS)
Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
repetitive Transcranial Magnetic Stimulation -OffDevice
Also called sham treatment, Control Group
Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
| Study group | Role | What they receive |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation -On | Active comparator | Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. Receives: Device: repetitive Transcranial Magnetic Stimulation -On |
| repetitive Transcranial Magnetic Stimulation -Off | Sham comparator | Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain. Receives: Device: repetitive Transcranial Magnetic Stimulation -Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brain Activation
Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI
Measured: One business day before treatment begins, one business day after treatment ends, up to 5 weeks
Secondary outcomes (6)
Fugl-Meyer Motor Arm Score
Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome
Measured: One business day before treatment begins, one business day after treatment ends up to 5 weeks
ARAT (Action Research Arm Test)
Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome
Measured: One business day before treatment begins, one business day after treatment ends up to 5 weeks
Hand Dynamometer
Change in grip strength The higher the number represents better outcome
Measured: One business day before treatment begins, one business day after treatment ends up to 5 weeks
Pinch Dynamometer Score
Change in pinch strength. The higher the number, the better the outcome.
Measured: One business day before treatment begins, one business day after treatment ends up to 5 weeks
TUG (Timed Up and Go Test)
Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.
Measured: One business day before treatment begins, one business day after treatment ends up to 5 weeks
National Institutes of Health Stroke Scale (NIHSS)
Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome
Measured: One business day before treatment begins, one business day after treatment ends up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start27 May 2016
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Chiu, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Seraya Medical
- Responsible party
- Sponsor-investigator, David Chiu, MD, The Methodist Hospital Research Institute
- Investigators
- David Chiu, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817087
- Sponsor's protocol ID
- Pro00014213
- Status last verified
- Sep 2020
- First submitted
- 31 Mar 2016
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rehme AK, Grefkes C. Cerebral network disorders after stroke: evidence from imaging-based connectivity analyses of active and resting brain states in humans. J Physiol. 2013 Jan 1;591(1):17-31. doi: 10.1113/jphysiol.2012.243469. Epub 2012 Oct 22.
PubMed 23090951Li W, Li Y, Zhu W, Chen X. Changes in brain functional network connectivity after stroke. Neural Regen Res. 2014 Jan 1;9(1):51-60. doi: 10.4103/1673-5374.125330.
PubMed 25206743Varsou O, Macleod MJ, Schwarzbauer C. Functional connectivity magnetic resonance imaging in stroke: an evidence-based clinical review. Int J Stroke. 2014 Feb;9(2):191-8. doi: 10.1111/ijs.12033. Epub 2013 Mar 19.
PubMed 23506092Ameli M, Grefkes C, Kemper F, Riegg FP, Rehme AK, Karbe H, Fink GR, Nowak DA. Differential effects of high-frequency repetitive transcranial magnetic stimulation over ipsilesional primary motor cortex in cortical and subcortical middle cerebral artery stroke. Ann Neurol. 2009 Sep;66(3):298-309. doi: 10.1002/ana.21725.
PubMed 19798637Chang WH, Kim YH, Bang OY, Kim ST, Park YH, Lee PK. Long-term effects of rTMS on motor recovery in patients after subacute stroke. J Rehabil Med. 2010 Sep;42(8):758-64. doi: 10.2340/16501977-0590.
PubMed 20809058Kim YH, You SH, Ko MH, Park JW, Lee KH, Jang SH, Yoo WK, Hallett M. Repetitive transcranial magnetic stimulation-induced corticomotor excitability and associated motor skill acquisition in chronic stroke. Stroke. 2006 Jun;37(6):1471-6. doi: 10.1161/01.STR.0000221233.55497.51. Epub 2006 May 4.
PubMed 16675743Khedr EM, Etraby AE, Hemeda M, Nasef AM, Razek AA. Long-term effect of repetitive transcranial magnetic stimulation on motor function recovery after acute ischemic stroke. Acta Neurol Scand. 2010 Jan;121(1):30-7. doi: 10.1111/j.1600-0404.2009.01195.x. Epub 2009 Aug 11.
PubMed 19678808Fitzgerald PB, Fountain S, Daskalakis ZJ. A comprehensive review of the effects of rTMS on motor cortical excitability and inhibition. Clin Neurophysiol. 2006 Dec;117(12):2584-96. doi: 10.1016/j.clinph.2006.06.712. Epub 2006 Aug 4.
PubMed 16890483Fregni F, Boggio PS, Valle AC, Rocha RR, Duarte J, Ferreira MJ, Wagner T, Fecteau S, Rigonatti SP, Riberto M, Freedman SD, Pascual-Leone A. A sham-controlled trial of a 5-day course of repetitive transcranial magnetic stimulation of the unaffected hemisphere in stroke patients. Stroke. 2006 Aug;37(8):2115-22. doi: 10.1161/01.STR.0000231390.58967.6b. Epub 2006 Jun 29.
PubMed 16809569Mally J, Dinya E. Recovery of motor disability and spasticity in post-stroke after repetitive transcranial magnetic stimulation (rTMS). Brain Res Bull. 2008 Jul 1;76(4):388-95. doi: 10.1016/j.brainresbull.2007.11.019. Epub 2007 Dec 26.
PubMed 18502315Boggio PS, Alonso-Alonso M, Mansur CG, Rigonatti SP, Schlaug G, Pascual-Leone A, Fregni F. Hand function improvement with low-frequency repetitive transcranial magnetic stimulation of the unaffected hemisphere in a severe case of stroke. Am J Phys Med Rehabil. 2006 Nov;85(11):927-30. doi: 10.1097/01.phm.0000242635.88129.38.
PubMed 17079967Grefkes C, Nowak DA, Wang LE, Dafotakis M, Eickhoff SB, Fink GR. Modulating cortical connectivity in stroke patients by rTMS assessed with fMRI and dynamic causal modeling. Neuroimage. 2010 Mar;50(1):233-42. doi: 10.1016/j.neuroimage.2009.12.029. Epub 2009 Dec 18.
PubMed 20005962Helekar, S.A., et al., Electromyographic motor-evoked potentials elicited by transcranial magnetic stimulation with rapidly moving permanent magnets mounted on a multisite stimulator cap, in 2013 Neuroscience Meeting Planner. 2013, Society for Neuroscience: San Diego, CA.
Ashburner J, Friston KJ. Nonlinear spatial normalization using basis functions. Hum Brain Mapp. 1999;7(4):254-66. doi: 10.1002/(SICI)1097-0193(1999)7:4<254::AID-HBM4>3.0.CO;2-G.
PubMed 10408769Tzourio-Mazoyer N, Landeau B, Papathanassiou D, Crivello F, Etard O, Delcroix N, Mazoyer B, Joliot M. Automated anatomical labeling of activations in SPM using a macroscopic anatomical parcellation of the MNI MRI single-subject brain. Neuroimage. 2002 Jan;15(1):273-89. doi: 10.1006/nimg.2001.0978.
PubMed 11771995
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator
- ClinicalTrials.gov ID
- NCT02817087
- Acronym / sponsor ID
- Pro00014213
- Conditions
- Stroke
- Keywords
- Stroke, chronic ischemic stroke, cerebrovascular accident (CVA), ischaemic stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- David Chiu, MDUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Seraya Medical
- Study start
- 27 May 2016 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.
Detailed description
This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved.
This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.
| Arm | Type | Receives |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation -On | Active comparator | Device: repetitive Transcranial Magnetic Stimulation -OnParticipants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. |
| repetitive Transcranial Magnetic Stimulation -Off | Sham comparator | Device: repetitive Transcranial Magnetic Stimulation -OffParticipants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-80 years;
- Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; --
Key exclusion criteria (14 listed)
- History of seizure;
- Epileptogenic activity (indicative of increased risk of seizures) on EEG;
- Any active unstable medical condition;
- Pregnancy;
- Schizophrenia, bipolar disorder, alcoholism, or substance abuse;
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 |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation -OnAlso: transcranial magnetic stimulation (TMS), Transcranial Rotating Permanent Magnet Stimulation (TRPMS), repetitive Transcranial Magnetic Stimulation (rTMS)Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain | Device | repetitive Transcranial Magnetic Stimulation -On |
| repetitive Transcranial Magnetic Stimulation -OffAlso: sham treatment, Control GroupCap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment. | Device | repetitive Transcranial Magnetic Stimulation -Off |
Primary outcome
Changes in Brain Activation
Time frame: One business day before treatment begins, one business day after treatment ends, up to 5 weeks
Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI
6 secondary outcomes
Fugl-Meyer Motor Arm Score
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
ARAT (Action Research Arm Test)
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
Hand Dynamometer
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
Pinch Dynamometer Score
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
TUG (Timed Up and Go Test)
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
National Institutes of Health Stroke Scale (NIHSS)
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23090951Rehme AK, Grefkes C. Cerebral network disorders after stroke: evidence from imaging-based connectivity analyses of active and resting brain states in humans. J Physiol. 2013 Jan 1;591(1):17-31. doi: 10.1113/jphysiol.2012.243469. Epub 2012 Oct 22.
- Background: PubMed 25206743Li W, Li Y, Zhu W, Chen X. Changes in brain functional network connectivity after stroke. Neural Regen Res. 2014 Jan 1;9(1):51-60. doi: 10.4103/1673-5374.125330.
- Background: PubMed 23506092Varsou O, Macleod MJ, Schwarzbauer C. Functional connectivity magnetic resonance imaging in stroke: an evidence-based clinical review. Int J Stroke. 2014 Feb;9(2):191-8. doi: 10.1111/ijs.12033. Epub 2013 Mar 19.
- Background: PubMed 19798637Ameli M, Grefkes C, Kemper F, Riegg FP, Rehme AK, Karbe H, Fink GR, Nowak DA. Differential effects of high-frequency repetitive transcranial magnetic stimulation over ipsilesional primary motor cortex in cortical and subcortical middle cerebral artery stroke. Ann Neurol. 2009 Sep;66(3):298-309. doi: 10.1002/ana.21725.
- Background: PubMed 20809058Chang WH, Kim YH, Bang OY, Kim ST, Park YH, Lee PK. Long-term effects of rTMS on motor recovery in patients after subacute stroke. J Rehabil Med. 2010 Sep;42(8):758-64. doi: 10.2340/16501977-0590.
- Background: PubMed 16675743Kim YH, You SH, Ko MH, Park JW, Lee KH, Jang SH, Yoo WK, Hallett M. Repetitive transcranial magnetic stimulation-induced corticomotor excitability and associated motor skill acquisition in chronic stroke. Stroke. 2006 Jun;37(6):1471-6. doi: 10.1161/01.STR.0000221233.55497.51. Epub 2006 May 4.
- Background: PubMed 19678808Khedr EM, Etraby AE, Hemeda M, Nasef AM, Razek AA. Long-term effect of repetitive transcranial magnetic stimulation on motor function recovery after acute ischemic stroke. Acta Neurol Scand. 2010 Jan;121(1):30-7. doi: 10.1111/j.1600-0404.2009.01195.x. Epub 2009 Aug 11.
- Background: PubMed 16890483Fitzgerald PB, Fountain S, Daskalakis ZJ. A comprehensive review of the effects of rTMS on motor cortical excitability and inhibition. Clin Neurophysiol. 2006 Dec;117(12):2584-96. doi: 10.1016/j.clinph.2006.06.712. Epub 2006 Aug 4.
- Background: PubMed 16809569Fregni F, Boggio PS, Valle AC, Rocha RR, Duarte J, Ferreira MJ, Wagner T, Fecteau S, Rigonatti SP, Riberto M, Freedman SD, Pascual-Leone A. A sham-controlled trial of a 5-day course of repetitive transcranial magnetic stimulation of the unaffected hemisphere in stroke patients. Stroke. 2006 Aug;37(8):2115-22. doi: 10.1161/01.STR.0000231390.58967.6b. Epub 2006 Jun 29.
- Background: PubMed 18502315Mally J, Dinya E. Recovery of motor disability and spasticity in post-stroke after repetitive transcranial magnetic stimulation (rTMS). Brain Res Bull. 2008 Jul 1;76(4):388-95. doi: 10.1016/j.brainresbull.2007.11.019. Epub 2007 Dec 26.
- Background: PubMed 17079967Boggio PS, Alonso-Alonso M, Mansur CG, Rigonatti SP, Schlaug G, Pascual-Leone A, Fregni F. Hand function improvement with low-frequency repetitive transcranial magnetic stimulation of the unaffected hemisphere in a severe case of stroke. Am J Phys Med Rehabil. 2006 Nov;85(11):927-30. doi: 10.1097/01.phm.0000242635.88129.38.
- Background: PubMed 20005962Grefkes C, Nowak DA, Wang LE, Dafotakis M, Eickhoff SB, Fink GR. Modulating cortical connectivity in stroke patients by rTMS assessed with fMRI and dynamic causal modeling. Neuroimage. 2010 Mar;50(1):233-42. doi: 10.1016/j.neuroimage.2009.12.029. Epub 2009 Dec 18.
- 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.
David Chiu, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation -On and repetitive Transcranial Magnetic Stimulation -Off in people with Stroke, run by David Chiu, MD at 1 site 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 2 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 Oct 2020. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Brain Activation (time frame: One business day before treatment begins, one business day after treatment ends, up to 5 weeks). 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 NCT02817087, which also lists 22 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 5 Oct 2020.