PTSDPhase 2NCT00383786
Substance P Antagonist in the Treatment of Posttraumatic Stress Disorder
A Phase 2 study testing NK1 Antagoist (GR205171), Psychophysiology (Trauma Script) and Psychophysiology (Verbal Threat) in people with PTSD, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- NK1 Antagoist (GR205171), Psychophysiology (Trauma Script) and Psychophysiology (Verbal Threat)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Jun 2009
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects may be included in the study only if they meet all of the following criteria:
- Male or female subjects, 18 to 65 years.
- Female subjects of childbearing potential must be using a medically accepted means of contraception.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- A negative urine toxicology.
- Subjects must fulfill the criteria for PTSD as defined in DSM-IV (309.81), which should be the primary diagnosis. Diagnoses are based on clinical assessment and confirmed by structured diagnostic interview SCID-P.
Show all 9Show fewer
- Duration of illness of PTSD for at least 3 months.
- Subjects must have an initial score at Visit 1 and Visit 2 of at least 50 on the CAPS for PTSD Studies.
- Subjects must not have a decrease in the total score of CAPS of greater than 25% during washout (between Visits 1 and 2).
Who cannot join
- Subjects will be excluded from the study for any of the following reasons:
- Presence of psychotic features.
- Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry (Visit 1).
- Female subjects who are either pregnant or nursing.
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
Show all 16Show fewer
- Previous treatment with NK1 receptor antagonist.
- DSM-IV substance abuse or dependence within the past 90 days.
- Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to Visit 2.
- Treatment with a reversible MAOI, guanethidine, or guanadrel within 1 week or with fluoxetine within 6 weeks prior to Visit 2.
- Treatment with any other concomitant medication with primarily CNS activity.
- Treatment with clozapine or ECT within 12 weeks prior to Visit 2.
- Current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder, other Axis I disorder (except for major depressive disorder, dysthymia and other anxiety disorders that followed exposure to the trauma) as defined in the DSM-IV.
- Patients who are currently at high risk for homicide or suicide, a score greater than 4 on item 10 of the MADRS.
- Current or planned litigation regarding the traumatic event.
- Patients will not be allowed to receive structured psychotherapy during the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Mt. Sinai Medical Center
New York, New York, 10029-0574
About this study
Official title: Evaluation of the Efficacy of the NK1 Antagonist GR205171 in Posttraumatic Stress Disorder
This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD).
People between 18 and 65 years of age who have been diagnosed with PTSD may be eligible for this study. Participants undergo the following tests and procedures:
Read more
Treatment: Patients are tapered off current ineffective medications over 1 to 2 weeks. All participants receive placebo (sugar pill) at the start of the study. At some point within the first 3 weeks of the study, they are then randomly assigned either to take GR205171 or to continue with placebo for the remainder of the 10-week treatment period.
Clinic visits: Patients come to the clinic once a week during treatment. The following procedures are done at various visits.
- Interviews, self report questionnaires and psychiatric rating scales at every visit.
- Physical examination, blood and urine tests. Blood is drawn up to 10 times during the study.
Follow-up visits continue for up to 3 months after the end of the study, during which patients are offered standard clinical treatment.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is a common chronic anxiety disorder that is often debilitating and follows exposure to an overwhelming traumatic event. The burden of PTSD on individuals and society is significant. The majority of PTSD sufferers also meet the diagnostic criteria for several other psychiatric disorders and many attempt suicide. Despite the devastating impact of PTSD on the lives of millions worldwide, little is known about the etiology or pathophysiology of this disorder. Although disruptions in the hypothalamic-pituitary adrenal (HPA) Axis, noradrenergic, serotonergic systems have been proposed as neurobiological substrates in the development of PTSD, the exact underpinnings of the neurobiology of PTSD remain to be fully elucidated.
PTSD is responsive to treatment with selective serotonin reuptake inhibitors, but response rates rarely exceed 60%, and even fewer patients (20%-30%) experience improvement that could be characterized as remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD. A growing body of preclinical evidence suggests that activation of the Substance P (SP) and its receptor NK1 is anxiogenic and that NK1 antagonists, upon chronic administration, exert significant dampening (albeit complex) effects on the SP-NP system. Furthermore, several stress paradigms are believed to exert many of their deleterious effects on hippocampal structures via enhancement of SP-NK1 system. Overall, excess activity of the SP-NK1 system stands as a prime candidate for involvement in the pathophysiology of anxiety disorders such as PTSD.
In this study, we propose to investigate the potential antianxiety efficacy of the highly specific NK1 antagonist GR205171 in PTSD. Furthermore, we propose to, in a preliminary fashion, longitudinally investigate whether neuroendocrine surrogate markers are predictive of treatment response.
This is an 8-week double-blind placebo-controlled study that will examine the efficacy and safety of an NK1 antagonist in patients with PTSD.
Patients, ages 18 to 65 years with a diagnosis of PTSD, will in this pilot study be randomized to double-blind treatment to receive either the NK1 antagonist, GR205171 (5 mg/day) or placebo for a period of 8 weeks.
Approximately 52 patients will enter the study to obtain 40 subjects who complete the 8 weeks of acute NK1 antagonist treatment.
- Conditions
- PTSD
- Being tested
- NK1 Antagoist (GR205171), Psychophysiology (Trauma Script), Psychophysiology (Verbal Threat), Psychophysiology (Fear Conditioning), Psychophysiology (Affective Modulation)
- Keywords
- PTSD, Substance P, Treatment Study, Placebo, Controlled, Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK1 Antagoist (GR205171)Drug
Psychophysiology (Trauma Script)Procedure or surgery
Psychophysiology (Verbal Threat)Procedure or surgery
Psychophysiology (Fear Conditioning)Procedure or surgery
Psychophysiology (Affective Modulation)Procedure or surgery
Psychophysiology (Heart rate variability)Procedure or surgery
Lumbar PunctureProcedure or surgery
24-hour plasma samplingProcedure or surgery
MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| GR205171 | Experimental | selective neurokinin-1 receptor antagonist, fixed 5 mg dose every day, for 8 weeks. Receives: Drug: NK1 Antagoist (GR205171); Procedure: Psychophysiology (Trauma Script); Procedure: Psychophysiology (Verbal Threat); Procedure: Psychophysiology (Fear Conditioning); Procedure: Psychophysiology (Affective Modulation); Procedure: Psychophysiology (Heart rate variability); Procedure: Lumbar Puncture; Procedure: 24-hour plasma sampling; Procedure: MRI |
| placebo | Placebo comparator | sugar pill Receives: Procedure: Psychophysiology (Trauma Script); Procedure: Psychophysiology (Verbal Threat); Procedure: Psychophysiology (Fear Conditioning); Procedure: Psychophysiology (Affective Modulation); Procedure: Psychophysiology (Heart rate variability); Procedure: Lumbar Puncture; Procedure: 24-hour plasma sampling; Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CAPS Scores.
The Clinician-Administered PTSD Scale (CAPS) is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. This is a 17-item core symptom scale, measuring both frequency and intensity of symptoms, with the most frequently used scoring rule is to count a symptom as present if it has a frequency of 1 or more and an intensity of 2 or more. A PTSD diagnosis is made if there is at least 1 "B" symptom, 3 "C" symptoms, and 2 "D" symptoms as well as meeting the other diagnostic criteria. Scores range from 0-136 0 (best possible outcome) to 136 (worst possible outcome). The relevant time-points for reporting change were at baseline and 8 weeks.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2009
- Study completionJun 2009
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 (4)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sanjay Johan Mathew, Baylor College of Medicine
- Investigators
- Dennis S Charney, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383786
- Sponsor's protocol ID
- 060253
- Other IDs
- 06-M-0253
- Status last verified
- Jul 2019
- First submitted
- 3 Oct 2006
- Last updated
- 31 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Agelink MW, Boz C, Ullrich H, Andrich J. Relationship between major depression and heart rate variability. Clinical consequences and implications for antidepressive treatment. Psychiatry Res. 2002 Dec 15;113(1-2):139-49. doi: 10.1016/s0165-1781(02)00225-1.
PubMed 12467953Ballard TM, Sanger S, Higgins GA. Inhibition of shock-induced foot tapping behaviour in the gerbil by a tachykinin NK1 receptor antagonist. Eur J Pharmacol. 2001 Feb 2;412(3):255-64. doi: 10.1016/s0014-2999(01)00724-5.
PubMed 11166289Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. doi: 10.1097/00005053-198612000-00004.
PubMed 3783140Mathew SJ, Vythilingam M, Murrough JW, Zarate CA Jr, Feder A, Luckenbaugh DA, Kinkead B, Parides MK, Trist DG, Bani MS, Bettica PU, Ratti EM, Charney DS. A selective neurokinin-1 receptor antagonist in chronic PTSD: a randomized, double-blind, placebo-controlled, proof-of-concept trial. Eur Neuropsychopharmacol. 2011 Mar;21(3):221-9. doi: 10.1016/j.euroneuro.2010.11.012. Epub 2010 Dec 30.
PubMed 21194898
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the NK1 Antagonist GR205171 in Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00383786
- Acronym / sponsor ID
- 060253
- Conditions
- PTSD
- Keywords
- PTSD, Substance P, Treatment Study, Placebo, Controlled, Post Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Oct 2006 (estimated)
- Results
- Posted 31 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD).
People between 18 and 65 years of age who have been diagnosed with PTSD may be eligible for this study. Participants undergo the following tests and procedures:
Treatment: Patients are tapered off current ineffective medications over 1 to 2 weeks. All participants receive placebo (sugar pill) at the start of the study. At some point within the first 3 weeks of the study, they are then randomly assigned either to take GR205171 or to continue with placebo for the remainder of the 10-week treatment period.
Clinic visits: Patients come to the clinic once a week during treatment. The following procedures are done at various visits.
- Interviews, self report questionnaires and psychiatric rating scales at every visit.
- Physical examination, blood and urine tests. Blood is drawn up to 10 times during the study.
Follow-up visits continue for up to 3 months after the end of the study, during which patients are offered standard clinical treatment.
Detailed description
Posttraumatic Stress Disorder (PTSD) is a common chronic anxiety disorder that is often debilitating and follows exposure to an overwhelming traumatic event. The burden of PTSD on individuals and society is significant. The majority of PTSD sufferers also meet the diagnostic criteria for several other psychiatric disorders and many attempt suicide. Despite the devastating impact of PTSD on the lives of millions worldwide, little is known about the etiology or pathophysiology of this disorder. Although disruptions in the hypothalamic-pituitary adrenal (HPA) Axis, noradrenergic, serotonergic systems have been proposed as neurobiological substrates in the development of PTSD, the exact underpinnings of the neurobiology of PTSD remain to be fully elucidated.
PTSD is responsive to treatment with selective serotonin reuptake inhibitors, but response rates rarely exceed 60%, and even fewer patients (20%-30%) experience improvement that could be characterized as remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD. A growing body of preclinical evidence suggests that activation of the Substance P (SP) and its receptor NK1 is anxiogenic and that NK1 antagonists, upon chronic administration, exert significant dampening (albeit complex) effects on the SP-NP system. Furthermore, several stress paradigms are believed to exert many of their deleterious effects on hippocampal structures via enhancement of SP-NK1 system. Overall, excess activity of the SP-NK1 system stands as a prime candidate for involvement in the pathophysiology of anxiety disorders such as PTSD.
In this study, we propose to investigate the potential antianxiety efficacy of the highly specific NK1 antagonist GR205171 in PTSD. Furthermore, we propose to, in a preliminary fashion, longitudinally investigate whether neuroendocrine surrogate markers are predictive of treatment response.
This is an 8-week double-blind placebo-controlled study that will examine the efficacy and safety of an NK1 antagonist in patients with PTSD.
Patients, ages 18 to 65 years with a diagnosis of PTSD, will in this pilot study be randomized to double-blind treatment to receive either the NK1 antagonist, GR205171 (5 mg/day) or placebo for a period of 8 weeks.
Approximately 52 patients will enter the study to obtain 40 subjects who complete the 8 weeks of acute NK1 antagonist treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GR205171 | Experimental | Drug: NK1 Antagoist (GR205171), Procedure: Psychophysiology (Trauma Script), Procedure: Psychophysiology (Verbal Threat), Procedure: Psychophysiology (Fear Conditioning), Procedure: Psychophysiology (Affective Modulation), Procedure: Psychophysiology (Heart rate variability), Procedure: Lumbar Puncture, Procedure: 24-hour plasma sampling, Procedure: MRIselective neurokinin-1 receptor antagonist, fixed 5 mg dose every day, for 8 weeks. |
| placebo | Placebo comparator | Procedure: Psychophysiology (Trauma Script), Procedure: Psychophysiology (Verbal Threat), Procedure: Psychophysiology (Fear Conditioning), Procedure: Psychophysiology (Affective Modulation), Procedure: Psychophysiology (Heart rate variability), Procedure: Lumbar Puncture, Procedure: 24-hour plasma sampling, Procedure: MRIsugar pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects, 18 to 65 years.
- Female subjects of childbearing potential must be using a medically accepted means of contraception.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- A negative urine toxicology.
- Subjects must fulfill the criteria for PTSD as defined in DSM-IV (309.81), which should be the primary diagnosis. Diagnoses are based on clinical assessment and confirmed by structured diagnostic interview SCID-P.
Key exclusion criteria (16 listed)
- Presence of psychotic features.
- Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry (Visit 1).
- Female subjects who are either pregnant or nursing.
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
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 |
|---|---|---|
| NK1 Antagoist (GR205171) | Drug | GR205171 |
| Psychophysiology (Trauma Script) | Procedure or surgery | GR205171, placebo |
| Psychophysiology (Verbal Threat) | Procedure or surgery | GR205171, placebo |
| Psychophysiology (Fear Conditioning) | Procedure or surgery | GR205171, placebo |
| Psychophysiology (Affective Modulation) | Procedure or surgery | GR205171, placebo |
| Psychophysiology (Heart rate variability) | Procedure or surgery | GR205171, placebo |
| Lumbar Puncture | Procedure or surgery | GR205171, placebo |
| 24-hour plasma sampling | Procedure or surgery | GR205171, placebo |
| MRI | Procedure or surgery | GR205171, placebo |
Primary outcome
Changes in CAPS Scores.
Time frame: Baseline, 8 weeks
The Clinician-Administered PTSD Scale (CAPS) is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. This is a 17-item core symptom scale, measuring both frequency and intensity of symptoms, with the most frequently used scoring rule is to count a symptom as present if it has a frequency of 1 or more and an intensity of 2 or more. A PTSD diagnosis is made if there is at least 1 "B" symptom, 3 "C" symptoms, and 2 "D" symptoms as well as meeting the other diagnostic criteria. Scores range from 0-136 0 (best possible outcome) to 136 (worst possible outcome). The relevant time-points for reporting change were at baseline and 8 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12467953Agelink MW, Boz C, Ullrich H, Andrich J. Relationship between major depression and heart rate variability. Clinical consequences and implications for antidepressive treatment. Psychiatry Res. 2002 Dec 15;113(1-2):139-49. doi: 10.1016/s0165-1781(02)00225-1.
- Background: PubMed 11166289Ballard TM, Sanger S, Higgins GA. Inhibition of shock-induced foot tapping behaviour in the gerbil by a tachykinin NK1 receptor antagonist. Eur J Pharmacol. 2001 Feb 2;412(3):255-64. doi: 10.1016/s0014-2999(01)00724-5.
- Background: PubMed 3783140Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. doi: 10.1097/00005053-198612000-00004.
- Derived from this study: PubMed 21194898Mathew SJ, Vythilingam M, Murrough JW, Zarate CA Jr, Feder A, Luckenbaugh DA, Kinkead B, Parides MK, Trist DG, Bani MS, Bettica PU, Ratti EM, Charney DS. A selective neurokinin-1 receptor antagonist in chronic PTSD: a randomized, double-blind, placebo-controlled, proof-of-concept trial. Eur Neuropsychopharmacol. 2011 Mar;21(3):221-9. doi: 10.1016/j.euroneuro.2010.11.012. Epub 2010 Dec 30.
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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.
Dennis S Charney, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NK1 Antagoist (GR205171), Psychophysiology (Trauma Script) and Psychophysiology (Verbal Threat) in people with PTSD, run by Baylor College of Medicine 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 9 inclusion and 16 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 31 Jul 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2014). 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 CAPS Scores. (time frame: Baseline, 8 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 NCT00383786, which also lists 4 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 31 Jul 2019.