Obsessive-Compulsive DisorderEQOLOCNCT02844049
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
A study testing Deep Brain Stimulation in people with Obsessive-Compulsive Disorder, run by University Hospital, Grenoble at 8 sites in 4 countries.
Trial summary
Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Sep 2016to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OCD for > 5 years
- YBOCS> 25 and/or YBOCS sub-scale >15
- GAF< 45
- 3 or more documented SRI trials, including clomipramine (10-12 weeks at adequate dose)
- SRI augmentation for > 4 weeks with at least one antipsychotic and with one of the following: lithium, clonazepam
- Adequate trial of CBT (Exposure Therapy and Response Prevention) (intolerance or >15 sessions)
- Ability to provide informed consent
Who cannot join
- Hoarding (if the only OCD symptom)
- OCD with poor insight (BABS score > 12)
- Lifetime diagnosis of psychosis or bipolar disorder;
- Substance abuse or dependence within the previous six months;
- Baseline Montgomery and Asberg (MADRS) suicidality item (item 10) score >2;
- Current DSM-5 personality disorder of Cluster A (e.g., paranoid or schizotypal personality disorder) or B (e.g., borderline or antisocial personality disorder);
Show all 9Show fewer
- Brain pathology, such as moderate or marked cerebral atrophy, stroke, tumor or previous neurosurgical procedures (i.e. capsulotomy etc), history of cognitive impairment and cognitive deterioration (Addenbrooke's Cognitive Examination ACE score of < 80).
- Contra-indications to surgery, anaesthesia, or MRI
- compulsory hospitalization/ care; pregnant or nursing patients
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
France5 sites, 4 recruiting
- Completed
CHU Henri Mondor
Créteil
- Recruiting
University Hospital of Grenoble Michallon
Grenoble
Mircea POLOSAN, MD PhD, 0033476765414, MPolosan@chu-grenoble.fr
Mircea Polosan, MD PhD
- Recruiting
Chu Nice - Hopital Pasteur
Nice
Denys FONTAINE, MD, 04 92 03 84 50, fontaine.d@chu-nice.fr
Hélène BRUCKER, 04 92 03 75 57, bruckert.h@chu-nice.fr
- Recruiting
APHP La Pitié Salpêtrière
Paris
Bruno Millet, MD PhD, 33142162894, b.millet@psl.aphp.fr
Carine KARACHI, MD
- Recruiting
Ghu Sainte Anne
Paris
Philippe DOMENECH, MD PhD, philippe.domenech@ghu-paris.fr
Djamila KORICHE, 0145657665, djamila.koriche@ghu-paris.fr
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Köln (AöR)
Cologne
Veerle VISSER-VANDEWALLE, MD, +49 221 478-82793, veerle.visser-vandewalle@uk-koeln.de
Jens KUHN, MD PhD
Sweden1 site, 1 recruiting
- Recruiting
Djurfeldt
Stockholm
Diana DJURFELDT, MD PhD, +46 72 211 9562, diana.pascal@ki.se
Diana DJURFELDT, MD PhD
Switzerland1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Genève
Geneva
Joao FLORES, MD, Joao.FloresAlvesDosSantos@hcuge.ch
Shahan MOMJIAN, MD
About this study
Official title: European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment
Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. These resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate neural networks. Although promising, these results need nevertheless to be replicated and confirmed within a larger cohort of patients and considering a different main objective, instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond symptom reduction, health-related quality of life (QoL) represents a more important objective of a treatment, as it includes both the individual's functional status and the individual's subjective perception of the impact of the illness on the patient's life. STN DBS induces significant clinical improvement, which may not be proportional to the QoL gain. Consequently, QoL appears to be a better outcome to target in the coming studies than clinical improvement alone. THe investigators thus propose a prospective study assessing the QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT) at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus BMT alone.
Read the detailed description
The study will focus on an innovative therapeutic strategy (DBS) and on an original objective, quality of life, which is considered to better reflect the impact of a therapeutic strategy. Moreover, the study will help to define the predictive biomarkers /biosignatures of response to STN DBS in OCD.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, Quality of Life
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called DBS
surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Active comparator | DBS surgical procedure scheduled and realized Receives: Device: Deep Brain Stimulation |
| Control group | No intervention | medical treatment (psycho- and pharmaco-therapy) will continue to be given and optimized according to the defined BMT strategies and criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Quality of life in resistant OCD patients at 1-year follow-up
QOL assessment : scores at SF36
Measured: 1 year
Secondary outcomes (22)
Psychiatric assessment n°1
clinical profile defined by score at YBOCS -Yale Brown Obsessive Compulsive Scale
Measured: 1 year
Psychiatric assessment n°2
clinical profile defined by score at DYBOCS- Dimensional Yale Brown Obsessive Compulsive Scale
Measured: 1 year
Psychiatric assessment n°3
clinical profile defined by score at YMRS (Young Mania Rating Scale)
Measured: 1 year
Psychiatric assessment n°4
clinical profile defined by score at HAMA (Hamilton Rating Scale for Anxiety)
Measured: 1 year
Psychiatric assessment n°5
clinical profile defined by score at STAI (State-Trait Anxiety Inventory)
Measured: 1 year
Psychiatric assessment n°6
clinical profile defined by score at UPPS-P Impulsive Behavior Scale
Measured: 1 year
Psychiatric assessment n°7
clinical profile defined by score at Clinical Global Impression (Severity of OCD)
Measured: 1 year
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1
Functioning scores : GAF (Global assessment functioning scale)
Measured: 1 year
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2
Functioning scores : WHODAS 2.0
Measured: 1 year
side effects
Number of patients with side effects related to medical treatment, surgery and to stimulation
Measured: 1 year
Psychiatric markers n°1
scores at Big Five Inventory
Measured: 1 year
Psychiatric markers n°2
scores at BABS (BROWN ASSESSMENT OF BELIEFS SCALE)
Measured: 1 year
Neurological markers n°3
score at UPDRS (Unified Parkinson's Disease Rating Scale)
Measured: 1 year
Neuropsychological markers n°4
Score at OBQ-44 (Obsessive Beliefs Questionnaire)
Measured: 1 year
Neuropsychological markers n°5
Score at MCQ (Metacognitions questionnaires)
Measured: 1 year
Neuropsychological markers n°6
Score at URICA (University Rhode Island Change Assessment Scale)
Measured: 1 year
Neuropsychological markers
Score at Addenbrooke Cognitive Examination (ACE) battery
Measured: 1 year
Per-op electrophysiological mapping of the STN activity n°1
electrophysiological parameters at rest and during OCD provocative tests
Measured: 1 year
Per-op electrophysiological mapping of the STN activity n°2
electrophysiological parameters at rest and during OCD uncertainty test
Measured: 1 year
Per-op electrophysiological mapping of the STN activity n°3
electrophysiological parameters at rest and during OCD emotional test
Measured: 1 year
Per-op electrophysiological mapping of the STN activity n°4
electrophysiological parameters at rest and during OCD cognitive and motor test
Measured: 1 year
Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD
Measure of suicidal risk with MADRS scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mircea Polosan, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844049
- Sponsor's protocol ID
- 38RC15.344
- Acronym
- EQOLOC
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2016
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Subramaniam M, Soh P, Vaingankar JA, Picco L, Chong SA. Quality of life in obsessive-compulsive disorder: impact of the disorder and of treatment. CNS Drugs. 2013 May;27(5):367-83. doi: 10.1007/s40263-013-0056-z.
PubMed 23580175Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
PubMed 19005196Kohl S, Schonherr DM, Luigjes J, Denys D, Mueller UJ, Lenartz D, Visser-Vandewalle V, Kuhn J. Deep brain stimulation for treatment-refractory obsessive compulsive disorder: a systematic review. BMC Psychiatry. 2014 Aug 2;14:214. doi: 10.1186/s12888-014-0214-y.
PubMed 25085317Eitan R, Shamir RR, Linetsky E, Rosenbluh O, Moshel S, Ben-Hur T, Bergman H, Israel Z. Asymmetric right/left encoding of emotions in the human subthalamic nucleus. Front Syst Neurosci. 2013 Oct 29;7:69. doi: 10.3389/fnsys.2013.00069. eCollection 2013.
PubMed 24194703Mataix-Cols D, Fernandez de la Cruz L, Nordsletten AE, Lenhard F, Isomura K, Simpson HB. Towards an international expert consensus for defining treatment response, remission, recovery and relapse in obsessive-compulsive disorder. World Psychiatry. 2016 Feb;15(1):80-1. doi: 10.1002/wps.20299. No abstract available.
PubMed 26833615Piallat B, Polosan M, Fraix V, Goetz L, David O, Fenoy A, Torres N, Quesada JL, Seigneuret E, Pollak P, Krack P, Bougerol T, Benabid AL, Chabardes S. Subthalamic neuronal firing in obsessive-compulsive disorder and Parkinson disease. Ann Neurol. 2011 May;69(5):793-802. doi: 10.1002/ana.22222. Epub 2010 Dec 28.
PubMed 21520240Ooms P, Mantione M, Figee M, Schuurman PR, van den Munckhof P, Denys D. Deep brain stimulation for obsessive-compulsive disorders: long-term analysis of quality of life. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):153-8. doi: 10.1136/jnnp-2012-302550. Epub 2013 May 28.
PubMed 23715912
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment
- ClinicalTrials.gov ID
- NCT02844049
- Acronym / sponsor ID
- EQOLOC / 38RC15.344
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Deep Brain Stimulation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 26 Jul 2016 (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.
Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. These resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate neural networks. Although promising, these results need nevertheless to be replicated and confirmed within a larger cohort of patients and considering a different main objective, instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond symptom reduction, health-related quality of life (QoL) represents a more important objective of a treatment, as it includes both the individual's functional status and the individual's subjective perception of the impact of the illness on the patient's life. STN DBS induces significant clinical improvement, which may not be proportional to the QoL gain. Consequently, QoL appears to be a better outcome to target in the coming studies than clinical improvement alone. THe investigators thus propose a prospective study assessing the QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT) at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus BMT alone.
Detailed description
The study will focus on an innovative therapeutic strategy (DBS) and on an original objective, quality of life, which is considered to better reflect the impact of a therapeutic strategy. Moreover, the study will help to define the predictive biomarkers /biosignatures of response to STN DBS in OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Active comparator | Device: Deep Brain StimulationDBS surgical procedure scheduled and realized |
| Control group | No intervention | –medical treatment (psycho- and pharmaco-therapy) will continue to be given and optimized according to the defined BMT strategies and criteria |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- OCD for > 5 years
- YBOCS> 25 and/or YBOCS sub-scale >15
- GAF< 45
- 3 or more documented SRI trials, including clomipramine (10-12 weeks at adequate dose)
- SRI augmentation for > 4 weeks with at least one antipsychotic and with one of the following: lithium, clonazepam
Key exclusion criteria (9 listed)
- Hoarding (if the only OCD symptom)
- OCD with poor insight (BABS score > 12)
- Lifetime diagnosis of psychosis or bipolar disorder;
- Substance abuse or dependence within the previous six months;
- Baseline Montgomery and Asberg (MADRS) suicidality item (item 10) score >2;
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 |
|---|---|---|
| Deep Brain StimulationAlso: DBSsurgical procedure | Device | Deep Brain Stimulation |
Primary outcome
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Quality of life in resistant OCD patients at 1-year follow-up
Time frame: 1 year
QOL assessment : scores at SF36
22 secondary outcomes
Psychiatric assessment n°1
Time frame: 1 year
Psychiatric assessment n°2
Time frame: 1 year
Psychiatric assessment n°3
Time frame: 1 year
Psychiatric assessment n°4
Time frame: 1 year
Psychiatric assessment n°5
Time frame: 1 year
Psychiatric assessment n°6
Time frame: 1 year
Psychiatric assessment n°7
Time frame: 1 year
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1
Time frame: 1 year
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2
Time frame: 1 year
side effects
Time frame: 1 year
Psychiatric markers n°1
Time frame: 1 year
Psychiatric markers n°2
Time frame: 1 year
Neurological markers n°3
Time frame: 1 year
Neuropsychological markers n°4
Time frame: 1 year
Neuropsychological markers n°5
Time frame: 1 year
Neuropsychological markers n°6
Time frame: 1 year
Neuropsychological markers
Time frame: 1 year
Per-op electrophysiological mapping of the STN activity n°1
Time frame: 1 year
Per-op electrophysiological mapping of the STN activity n°2
Time frame: 1 year
Per-op electrophysiological mapping of the STN activity n°3
Time frame: 1 year
Per-op electrophysiological mapping of the STN activity n°4
Time frame: 1 year
Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 23580175Subramaniam M, Soh P, Vaingankar JA, Picco L, Chong SA. Quality of life in obsessive-compulsive disorder: impact of the disorder and of treatment. CNS Drugs. 2013 May;27(5):367-83. doi: 10.1007/s40263-013-0056-z.
- Background: PubMed 19005196Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
- Background: PubMed 25085317Kohl S, Schonherr DM, Luigjes J, Denys D, Mueller UJ, Lenartz D, Visser-Vandewalle V, Kuhn J. Deep brain stimulation for treatment-refractory obsessive compulsive disorder: a systematic review. BMC Psychiatry. 2014 Aug 2;14:214. doi: 10.1186/s12888-014-0214-y.
- Background: PubMed 24194703Eitan R, Shamir RR, Linetsky E, Rosenbluh O, Moshel S, Ben-Hur T, Bergman H, Israel Z. Asymmetric right/left encoding of emotions in the human subthalamic nucleus. Front Syst Neurosci. 2013 Oct 29;7:69. doi: 10.3389/fnsys.2013.00069. eCollection 2013.
- Background: PubMed 26833615Mataix-Cols D, Fernandez de la Cruz L, Nordsletten AE, Lenhard F, Isomura K, Simpson HB. Towards an international expert consensus for defining treatment response, remission, recovery and relapse in obsessive-compulsive disorder. World Psychiatry. 2016 Feb;15(1):80-1. doi: 10.1002/wps.20299. No abstract available.
- Background: PubMed 21520240Piallat B, Polosan M, Fraix V, Goetz L, David O, Fenoy A, Torres N, Quesada JL, Seigneuret E, Pollak P, Krack P, Bougerol T, Benabid AL, Chabardes S. Subthalamic neuronal firing in obsessive-compulsive disorder and Parkinson disease. Ann Neurol. 2011 May;69(5):793-802. doi: 10.1002/ana.22222. Epub 2010 Dec 28.
- Background: PubMed 23715912Ooms P, Mantione M, Figee M, Schuurman PR, van den Munckhof P, Denys D. Deep brain stimulation for obsessive-compulsive disorders: long-term analysis of quality of life. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):153-8. doi: 10.1136/jnnp-2012-302550. Epub 2013 May 28.
- 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.
Mircea Polosan, MD PhD principal investigator
University Hospital, Grenoble
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Obsessive-Compulsive Disorder, run by University Hospital, Grenoble at 8 sites in 4 countries.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Germany, Sweden, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra David-tchouda, MD (+33476767186, SDavidTchouda@chugrenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Quality of life in resistant OCD patients at 1-year follow-up (time frame: 1 year). 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 NCT02844049, which also lists 7 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 29 Nov 2023.