Normal Pressure HydrocephalusPLHPNNCT03877107
Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH
A study testing Urinary symptoms profile questionnaire and Micturition calendar in people with Normal Pressure Hydrocephalus, run by EssaiClinique_PL-HPN at 2 sites in France.
Trial summary
Lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. Urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which is a significant burden for the concerned patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Urinary symptoms profile questionnaire and Micturition calendar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Mar 2019to 1 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 2/3 symptoms triad : gait disturbance + cognitive disturbance + urinary symptoms
- Ventricular enlargement non explained by cortical atrophy
Who cannot join
- analphabetism or not french speaking
- Cognitive disability making understanding of study impossible (as informed consent)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
University Hospital of Grenoble
Grenoble, 38000
Jean Alexandre LONG, MD PHD, +334 76 76 76 42, JALong@chu-grenoble.fr
Elsa Bey, Resident
- Recruiting
University Hospital of Lyon
Lyon, 69000
Caroline Tilikete, MD PHD, caroline.tilikete@chu-lyon.fr
Romain Manet, MD
About this study
Official title: Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus
Lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. Urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which is a significant burden for the concerned patients. A harmonization of neuro-urological practices in the pre-therapeutic evaluation of patients suffering from normal pressure hydrocephalus is necessary.
The investigators conducted a bicentric prospective study aiming to evaluate the effect of depletive lumbar puncture on urinary symptoms in iNPH.
The secondary objective was to evaluate, in the same participants previously diagnosed, the effect of cerebrospinal fluid shunt surgery on urinary symptoms.
Read the detailed description
Prospective study interventional but non invasive Bicentric in two universitarian hospitals in France On a cohort of patients presenting at least two out of three symptoms of the classic triad (urinary symptoms, cognitive symptoms and gait disturbance) and enlargement of ventricles non explained by cortical atrophy.
Participants are offered, as routine care, a diagnostic evaluation of the effect of depletive lumbar puncture on these triad symptoms (this exam is part of routine care).
Before the planned lumbar puncture, the participants are requested to participate to the study, with written consent and information given. The participants are requested to fill in a USP (urinary symptoms profile, validated international questionnaire) questionnaire and a micturition calendar. The same urinary evaluation is made 5 days after lumbar puncture. Gait and cognition are evaluated as in routine practice.
Of the participants initially evaluated, some will be proposed shunt surgery (routine care). These participants will be proposed to fill in the same questionnaire and micturition calendar around 3 months after shunt surgery (post operative evaluation).
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- Urinary symptoms profile questionnaire, Micturition calendar
- Keywords
- lower urinary tract dysfunction, urinary incontinence, normal pressure hydrocephalus, overactive bladder
- Medical subject headings
- Hydrocephalus, Normal Pressure, Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary symptoms profile questionnaireDiagnostic test
Validated questionnaire (international) with validated french translation, before and after lumbar puncture, and after surgery if surgery is realized
Micturition calendarDiagnostic test
Micturition calendar on 2 consecutive days, before and after lumbar puncture, and after surgery if surgery is realized
| Study group | Role | What they receive |
|---|---|---|
| single cohort | Other | Participants presenting at least 2/3 of symptom triad : gait disturbance, urinary symptoms and cognitive disturbance Ventricular enlargement non explained by cortical atrophy Cognitive capacity to understand the study and give informed consent (mini mental state > 13), speaking and reading french. Receives: Diagnostic Test: Urinary symptoms profile questionnaire; Diagnostic Test: Micturition calendar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of depletive lumbar puncture on overactive bladder symptoms 1
evaluation on USP questionnaire, subsection HAV [0-21]
Measured: 5 days after lumbar puncture
Effect of depletive lumbar puncture on overactive bladder symptoms 2
evaluation on micturition calendar on 2 days [number of mictions/day]
Measured: 5 days after lumbar puncture
Secondary outcomes (2)
Effect of shunt surgery on overactive bladder symptoms 1
evaluation on micturition calendar on 2 days [number of mictions/day]
Measured: 3 to 4 months after surgery
Effect of shunt surgery on overactive bladder symptoms 2
evaluation on USP questionnaire, subsection HAV [0-21]
Measured: 3 to 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start13 Mar 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Normal Pressure HydrocephalusStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluation of urinary symptoms before and after depletive lumbar puncture and after shunt surgery
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EssaiClinique_PL-HPN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, EssaiClinique_PL-HPN, University Hospital, Grenoble
- Investigators
- Jean Alexandre LONG, MD PHD, Study director, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877107
- Sponsor's protocol ID
- PL HPN
- Acronym
- PLHPN
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mary P, Gallisa JM, Laroque S, Bedou G, Maillard A, Bousquet C, Negre C, Gaillard N, Dutray A, Fadat B, Jurici S, Olivier N, Cisse B, Sablot D. [Predictive value of postural and dynamic walking parameters after high-volume lumbar puncture in normal pressure hydrocephalus]. Rev Neurol (Paris). 2013 Apr;169(4):321-7. doi: 10.1016/j.neurol.2012.09.010. Epub 2013 Feb 12. French.
PubMed 23415160Jonas S, Brown J. Neurogenic bladder in normal pressure hydrocephalus. Urology. 1975 Jan;5(1):44-50. doi: 10.1016/0090-4295(75)90300-3.
PubMed 1114545Sakakibara R, Uchida Y, Ishii K, Kazui H, Hashimoto M, Ishikawa M, Yuasa T, Kishi M, Ogawa E, Tateno F, Uchiyama T, Yamamoto T, Yamanishi T, Terada H; SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement). Correlation of right frontal hypoperfusion and urinary dysfunction in iNPH: a SPECT study. Neurourol Urodyn. 2012 Jan;31(1):50-5. doi: 10.1002/nau.21222. Epub 2011 Oct 28.
PubMed 22038765Sakakibara R, Kanda T, Sekido T, Uchiyama T, Awa Y, Ito T, Liu Z, Yamamoto T, Yamanishi T, Yuasa T, Shirai K, Hattori T. Mechanism of bladder dysfunction in idiopathic normal pressure hydrocephalus. Neurourol Urodyn. 2008;27(6):507-10. doi: 10.1002/nau.20547.
PubMed 18092331Sakakibara R, Uchiyama T, Kanda T, Uchida Y, Kishi M, Hattori T. [Urinary dysfunction in idiopathic normal pressure hydrocephalus]. Brain Nerve. 2008 Mar;60(3):233-9. Japanese.
PubMed 18402070Campos-Juanatey F, Gutierrez-Banos JL, Portillo-Martin JA, Zubillaga-Guerrero S. Assessment of the urodynamic diagnosis in patients with urinary incontinence associated with normal pressure hydrocephalus. Neurourol Urodyn. 2015 Jun;34(5):465-8. doi: 10.1002/nau.22600. Epub 2014 Apr 12.
PubMed 24729303Kazui H, Mori E, Ohkawa S, Okada T, Kondo T, Sakakibara R, Ueki O, Nishio Y, Ishii K, Kawaguchi T, Ishikawa M, Takeda M. Predictors of the disappearance of triad symptoms in patients with idiopathic normal pressure hydrocephalus after shunt surgery. J Neurol Sci. 2013 May 15;328(1-2):64-9. doi: 10.1016/j.jns.2013.02.020. Epub 2013 Mar 16.
PubMed 23510566Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.
PubMed 20097391Sakakibara R. Lower urinary tract dysfunction in patients with brain lesions. Handb Clin Neurol. 2015;130:269-87. doi: 10.1016/B978-0-444-63247-0.00015-8.
PubMed 26003249Griffiths D, Tadic SD. Bladder control, urgency, and urge incontinence: evidence from functional brain imaging. Neurourol Urodyn. 2008;27(6):466-74. doi: 10.1002/nau.20549.
PubMed 18092336Sakakibara R, Panicker J, Fowler CJ, Tateno F, Kishi M, Tsuyusaki Y, Yamanishi T, Uchiyama T, Yamamoto T, Yano M. Is overactive bladder a brain disease? The pathophysiological role of cerebral white matter in the elderly. Int J Urol. 2014 Jan;21(1):33-8. doi: 10.1111/iju.12288. Epub 2013 Sep 30.
PubMed 24118122Sakakibara R, Uchida Y, Ishii K, Hashimoto M, Ishikawa M, Kazui H, Yamamoto T, Uchiyama T, Tateno F, Kishi M, Tsuyusaki Y, Aiba Y, Tateno H, Nagao T, Terada H, Inaoka T; Members of SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement). Bladder recovery relates with increased mid-cingulate perfusion after shunt surgery in idiopathic normal-pressure hydrocephalus: a single-photon emission tomography study. Int Urol Nephrol. 2016 Feb;48(2):169-74. doi: 10.1007/s11255-015-1162-2. Epub 2015 Nov 17.
PubMed 26578001Kang K, Hwang SK, Lee HW. Shunt-responsive idiopathic normal pressure hydrocephalus patient with delayed improvement after tap test. J Korean Neurosurg Soc. 2013 Nov;54(5):437-40. doi: 10.3340/jkns.2013.54.5.437. Epub 2013 Nov 30.
PubMed 24379955Wikkelso C, Andersson H, Blomstrand C, Lindqvist G. The clinical effect of lumbar puncture in normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 1982 Jan;45(1):64-9. doi: 10.1136/jnnp.45.1.64.
PubMed 7062072Lim TS, Yong SW, Moon SY. Repetitive lumbar punctures as treatment for normal pressure hydrocephalus. Eur Neurol. 2009;62(5):293-7. doi: 10.1159/000235808. Epub 2009 Aug 27.
PubMed 19713705
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT03877107
- Acronym / sponsor ID
- PLHPN / PL HPN
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- lower urinary tract dysfunction, urinary incontinence, normal pressure hydrocephalus, overactive bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- EssaiClinique_PL-HPNUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 15 Mar 2019 (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.
Lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. Urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which is a significant burden for the concerned patients. A harmonization of neuro-urological practices in the pre-therapeutic evaluation of patients suffering from normal pressure hydrocephalus is necessary.
The investigators conducted a bicentric prospective study aiming to evaluate the effect of depletive lumbar puncture on urinary symptoms in iNPH.
The secondary objective was to evaluate, in the same participants previously diagnosed, the effect of cerebrospinal fluid shunt surgery on urinary symptoms.
Detailed description
Prospective study interventional but non invasive Bicentric in two universitarian hospitals in France On a cohort of patients presenting at least two out of three symptoms of the classic triad (urinary symptoms, cognitive symptoms and gait disturbance) and enlargement of ventricles non explained by cortical atrophy.
Participants are offered, as routine care, a diagnostic evaluation of the effect of depletive lumbar puncture on these triad symptoms (this exam is part of routine care).
Before the planned lumbar puncture, the participants are requested to participate to the study, with written consent and information given. The participants are requested to fill in a USP (urinary symptoms profile, validated international questionnaire) questionnaire and a micturition calendar. The same urinary evaluation is made 5 days after lumbar puncture. Gait and cognition are evaluated as in routine practice.
Of the participants initially evaluated, some will be proposed shunt surgery (routine care). These participants will be proposed to fill in the same questionnaire and micturition calendar around 3 months after shunt surgery (post operative evaluation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluation of urinary symptoms before and after depletive lumbar puncture and after shunt surgery
| Arm | Type | Receives |
|---|---|---|
| single cohort | Other | Diagnostic Test: Urinary symptoms profile questionnaire, Diagnostic Test: Micturition calendarParticipants presenting at least 2/3 of symptom triad : gait disturbance, urinary symptoms and cognitive disturbance Ventricular enlargement non explained by cortical atrophy Cognitive capacity to understand the study and give informed consent (mini mental state > 13), speaking and reading french. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 2/3 symptoms triad : gait disturbance + cognitive disturbance + urinary symptoms
- Ventricular enlargement non explained by cortical atrophy
Key exclusion criteria (2 listed)
- analphabetism or not french speaking
- Cognitive disability making understanding of study impossible (as informed consent)
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 |
|---|---|---|
| Urinary symptoms profile questionnaireValidated questionnaire (international) with validated french translation, before and after lumbar puncture, and after surgery if surgery is realized | Diagnostic test | single cohort |
| Micturition calendarMicturition calendar on 2 consecutive days, before and after lumbar puncture, and after surgery if surgery is realized | Diagnostic test | single cohort |
Primary outcome
Effect of depletive lumbar puncture on overactive bladder symptoms 1
Time frame: 5 days after lumbar puncture
evaluation on USP questionnaire, subsection HAV [0-21]
Effect of depletive lumbar puncture on overactive bladder symptoms 2
Time frame: 5 days after lumbar puncture
evaluation on micturition calendar on 2 days [number of mictions/day]
2 secondary outcomes
Effect of shunt surgery on overactive bladder symptoms 1
Time frame: 3 to 4 months after surgery
Effect of shunt surgery on overactive bladder symptoms 2
Time frame: 3 to 4 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 23415160Mary P, Gallisa JM, Laroque S, Bedou G, Maillard A, Bousquet C, Negre C, Gaillard N, Dutray A, Fadat B, Jurici S, Olivier N, Cisse B, Sablot D. [Predictive value of postural and dynamic walking parameters after high-volume lumbar puncture in normal pressure hydrocephalus]. Rev Neurol (Paris). 2013 Apr;169(4):321-7. doi: 10.1016/j.neurol.2012.09.010. Epub 2013 Feb 12. French.
- Results publication: PubMed 1114545Jonas S, Brown J. Neurogenic bladder in normal pressure hydrocephalus. Urology. 1975 Jan;5(1):44-50. doi: 10.1016/0090-4295(75)90300-3.
- Results publication: PubMed 22038765Sakakibara R, Uchida Y, Ishii K, Kazui H, Hashimoto M, Ishikawa M, Yuasa T, Kishi M, Ogawa E, Tateno F, Uchiyama T, Yamamoto T, Yamanishi T, Terada H; SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement). Correlation of right frontal hypoperfusion and urinary dysfunction in iNPH: a SPECT study. Neurourol Urodyn. 2012 Jan;31(1):50-5. doi: 10.1002/nau.21222. Epub 2011 Oct 28.
- Results publication: PubMed 18092331Sakakibara R, Kanda T, Sekido T, Uchiyama T, Awa Y, Ito T, Liu Z, Yamamoto T, Yamanishi T, Yuasa T, Shirai K, Hattori T. Mechanism of bladder dysfunction in idiopathic normal pressure hydrocephalus. Neurourol Urodyn. 2008;27(6):507-10. doi: 10.1002/nau.20547.
- Results publication: PubMed 18402070Sakakibara R, Uchiyama T, Kanda T, Uchida Y, Kishi M, Hattori T. [Urinary dysfunction in idiopathic normal pressure hydrocephalus]. Brain Nerve. 2008 Mar;60(3):233-9. Japanese.
- Results publication: PubMed 24729303Campos-Juanatey F, Gutierrez-Banos JL, Portillo-Martin JA, Zubillaga-Guerrero S. Assessment of the urodynamic diagnosis in patients with urinary incontinence associated with normal pressure hydrocephalus. Neurourol Urodyn. 2015 Jun;34(5):465-8. doi: 10.1002/nau.22600. Epub 2014 Apr 12.
- Results publication: PubMed 23510566Kazui H, Mori E, Ohkawa S, Okada T, Kondo T, Sakakibara R, Ueki O, Nishio Y, Ishii K, Kawaguchi T, Ishikawa M, Takeda M. Predictors of the disappearance of triad symptoms in patients with idiopathic normal pressure hydrocephalus after shunt surgery. J Neurol Sci. 2013 May 15;328(1-2):64-9. doi: 10.1016/j.jns.2013.02.020. Epub 2013 Mar 16.
- Results publication: PubMed 20097391Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.
- Results publication: PubMed 26003249Sakakibara R. Lower urinary tract dysfunction in patients with brain lesions. Handb Clin Neurol. 2015;130:269-87. doi: 10.1016/B978-0-444-63247-0.00015-8.
- Results publication: PubMed 18092336Griffiths D, Tadic SD. Bladder control, urgency, and urge incontinence: evidence from functional brain imaging. Neurourol Urodyn. 2008;27(6):466-74. doi: 10.1002/nau.20549.
- Results publication: PubMed 24118122Sakakibara R, Panicker J, Fowler CJ, Tateno F, Kishi M, Tsuyusaki Y, Yamanishi T, Uchiyama T, Yamamoto T, Yano M. Is overactive bladder a brain disease? The pathophysiological role of cerebral white matter in the elderly. Int J Urol. 2014 Jan;21(1):33-8. doi: 10.1111/iju.12288. Epub 2013 Sep 30.
- Results publication: PubMed 26578001Sakakibara R, Uchida Y, Ishii K, Hashimoto M, Ishikawa M, Kazui H, Yamamoto T, Uchiyama T, Tateno F, Kishi M, Tsuyusaki Y, Aiba Y, Tateno H, Nagao T, Terada H, Inaoka T; Members of SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement). Bladder recovery relates with increased mid-cingulate perfusion after shunt surgery in idiopathic normal-pressure hydrocephalus: a single-photon emission tomography study. Int Urol Nephrol. 2016 Feb;48(2):169-74. doi: 10.1007/s11255-015-1162-2. Epub 2015 Nov 17.
- 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.
Jean Alexandre LONG, MD PHD study director
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary symptoms profile questionnaire and Micturition calendar in people with Normal Pressure Hydrocephalus, run by EssaiClinique_PL-HPN at 2 sites in France.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Alexandre LONG, MD PHD (+334 76 76 76 42, JALong@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of depletive lumbar puncture on overactive bladder symptoms 1 (time frame: 5 days after lumbar puncture). The study lists 2 primary outcomes in all. 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 NCT03877107, which also lists 18 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 19 Mar 2019.