Parkinson's DiseasePhase 1NCT02324426
CNS Uptake of Intranasal Glutathione
A Phase 1 study testing Reduced Glutathione in people with Parkinson's Disease, run by University of Washington at 1 site in United States.
Trial summary
Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Reduced Glutathione
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2015
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Ability to attend a 3 hour study visit in Seattle, WA.
- Ability to read and speak English.
- Have three or more of the required positive criteria for PD from Step 3 of the UK Brain Bank Diagnostic Criteria for Parkinson's Disease.
- A modified Hoehn \& Yahr Stage 2-3. (bilateral disease, not severely disabled.)
Who cannot join
- Any contra-indication to magnetic resonance imaging, including pacemaker, pacemaker wires, aneurysm clip, or any electronic implant, weight over 136 kg (300 lb), metal embedded in soft tissue or in the eye, prosthetic eye, claustrophobia, substance abuse, use of recreational drugs, pregnancy, or other medical contraindications.
- A history of epilepsy, stroke, brain surgery, or structural brain disease.
- The presence of other serious illnesses (discretion of study clinician, e.g. concurrent cancer treatment.)
- Pregnant.
- A history of sulfur sensitivity, e.g. reaction N-acetylcysteine, MSM, SAMe.
- A recent history of asthma.
Show all 14Show fewer
- Supplementation with glutathione (oral, intravenous, intranasal, or nebulized) or the glutathione precursor, N-acetylcysteine, for six months prior to baseline study visit.
- History of sensitivity to sulfur containing medications/ supplements, i.e. NAC, MSM.
- Current drug or alcohol use or dependence.
- Inability/unwillingness to provide informed consent. (e.g. diagnosis of dementia, confusion about study goals or participation.)
- Acute infection (e.g. upper respiratory, dermal) in the previous 30 days.
- Diagnosis of any mental illness, ever. (Mental illness has been associated with glutathione depletion.)
- Diagnosis of any chronic disease, ever. (e.g. Hep C, autoimmune disease, etc.)
- Head tremor or head dyskinesia that cannot be comfortably controlled for 90 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Nervous System Uptake of Intranasal Glutathione in Parkinson's Disease
Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles surrounding currently employed delivery methods have hindered the clinical utility of this therapy. Intranasal GSH, (in)GSH, is a novel method of glutathione augmentation. The aim of this study is to evaluate whether 200 mg of (in)GSH results in measurable changes in brain glutathione concentrations, as measured by magnetic resonance spectroscopy (MRS) in 15 individuals with PD.
Read the detailed description
Objectives
Primary Aim: To determine whether intranasal reduced glutathione, (in)GSH, is capable of augmenting CNS glutathione levels.
Hypothesis: Mean MRS glutathione concentration will rise from baseline following administration of 1 cc 200 mg/ml (in)GSH.
Design and Outcomes:
This pilot study seeks to obtain baseline data regarding the feasibility of MRS to detect a change in CNS glutathione concentration following administration of 200 mg (in)GSH. CNS glutathione levels will be measured using magnetic resonance spectroscopy (MRS), with the putamen as the region of interest. Baseline brain GSH concentrations will be measured by MRS at approximately the same time each day in all individuals before and after administration of study medication.
Outcome Measure: Describe the change in mean GSH concentration following administration of (in)GSH. The data analysis will be ipsative- results will be reported as percent change from the individual's own baseline GSH concentration.
Interventions and Duration:
If a participant communicates he/she understands the study, meets inclusion criteria, and provides informed consent, individuals will be scheduled for a single visit at the University of Washington for MR imaging (MRI), clinical evaluation, and blood draw. (~ 3 hours). Participants will be asked to be optimally medicated at the time of study visit, to the best of their ability.
Sample Size and Population:
This is a proof-of-concept pilot trial. Based on the data from the single test subject, a sample size of 15 would provide 80% power to detect an increase in CNS glutathione concentrations between pre- and post- administration values, if we are willing to accept an alpha value of 0.2.
1.1 Primary Aims
Primary Aim: To determine whether intranasal reduced glutathione, (in)GSH, is capable of augmenting CNS glutathione concentration. (Region of Interest: putamen)
Hypothesis: Mean MRS glutathione concentration will rise from baseline approximately 15 minutes following administration of 200 mg/ml (in)GSH in 1 cc saline.
1.2 Secondary Objectives
Hypothesis: Baseline CNS glutathione concentrations and RBC glutathione concentrations will be correlated.
- To determine whether brain MRS [glutathione] and red blood cell (RBC) glutathione levels are correlated.
Outcome: A ROC curve will be drawn between mean brain [glutathione] and RBC total glutathione.
- Conditions
- Parkinson's Disease
- Being tested
- Reduced Glutathione
- Keywords
- Parkinson's Disease, Reduced Glutathione, CNS, Glutathione, Uptake, Intranasal, (in)GSH
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced GlutathioneDrug
Also called (in)GSH
200 mg GSH delivered in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Glutathione | Experimental | The study medication is packaged in sterile 1 ml pre-filled syringes, each containing 200 mg/ ml of reduced glutathione (GSH), which will be delivered intranasally. Receives: Drug: Reduced Glutathione |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of metabolites before and after (in)GSH will be compared (change in mean GSH concentration)
Describe the change in mean GSH concentration following administration of (in)GSH. The data analysis will be ipsative- results will be reported as percent change from the individual's own baseline GSH concentration.
Measured: 15 minutes after administration
Secondary outcomes (1)
A ROC curve will be generated to compare MRS [glutathione] to peripheral measures of RBC glutathione.
Measured: 15 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Laurie Mischley, University of Washington
- Investigators
- Kevin Conley, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324426
- Sponsor's protocol ID
- 48273-A
- Status last verified
- Mar 2015
- First submitted
- 4 Dec 2014
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Coyle JT, Puttfarcken P. Oxidative stress, glutamate, and neurodegenerative disorders. Science. 1993 Oct 29;262(5134):689-95. doi: 10.1126/science.7901908.
PubMed 7901908Mischley, L. Glutathione Deficiency in Parkinson's Disease: Intranasal Administration as a Method of Augmentation. Journal of Orthomolecular Medicine 26(1):32-36, 2011.
Bains JS, Shaw CA. Neurodegenerative disorders in humans: the role of glutathione in oxidative stress-mediated neuronal death. Brain Res Brain Res Rev. 1997 Dec;25(3):335-58. doi: 10.1016/s0165-0173(97)00045-3.
PubMed 9495562Cacciatore I, Baldassarre L, Fornasari E, Mollica A, Pinnen F. Recent advances in the treatment of neurodegenerative diseases based on GSH delivery systems. Oxid Med Cell Longev. 2012;2012:240146. doi: 10.1155/2012/240146. Epub 2012 Jun 3.
PubMed 22701755Shils ME OJ, Shike, Moshe. Evolution of Knowledge of Essential Nutrients: Conditional Essentiality. Modern Nutrition in Health and Disease. Philadelphia: Lippincott Williams & Wilkins; 2006.
Mullins PG, McGonigle DJ, O'Gorman RL, Puts NA, Vidyasagar R, Evans CJ; Cardiff Symposium on MRS of GABA; Edden RA. Current practice in the use of MEGA-PRESS spectroscopy for the detection of GABA. Neuroimage. 2014 Feb 1;86:43-52. doi: 10.1016/j.neuroimage.2012.12.004. Epub 2012 Dec 13.
PubMed 23246994Maher P. The effects of stress and aging on glutathione metabolism. Ageing Res Rev. 2005 May;4(2):288-314. doi: 10.1016/j.arr.2005.02.005.
PubMed 15936251Pocernich CB, Cardin AL, Racine CL, Lauderback CM, Butterfield DA. Glutathione elevation and its protective role in acrolein-induced protein damage in synaptosomal membranes: relevance to brain lipid peroxidation in neurodegenerative disease. Neurochem Int. 2001 Aug;39(2):141-9. doi: 10.1016/s0197-0186(01)00012-2.
PubMed 11408093Sian J, Dexter DT, Lees AJ, Daniel S, Agid Y, Javoy-Agid F, Jenner P, Marsden CD. Alterations in glutathione levels in Parkinson's disease and other neurodegenerative disorders affecting basal ganglia. Ann Neurol. 1994 Sep;36(3):348-55. doi: 10.1002/ana.410360305.
PubMed 8080242Sofic E, Lange KW, Jellinger K, Riederer P. Reduced and oxidized glutathione in the substantia nigra of patients with Parkinson's disease. Neurosci Lett. 1992 Aug 17;142(2):128-30. doi: 10.1016/0304-3940(92)90355-b.
PubMed 1454205Sechi G, Deledda MG, Bua G, Satta WM, Deiana GA, Pes GM, Rosati G. Reduced intravenous glutathione in the treatment of early Parkinson's disease. Prog Neuropsychopharmacol Biol Psychiatry. 1996 Oct;20(7):1159-70. doi: 10.1016/s0278-5846(96)00103-0.
PubMed 8938817Mischley LK SL, Samii A, Pollisar N, Lau R, Leverenz J, . Phase I Study of Intranasal Glutathione in Parkinson's Disease. Seattle: Bastyr University Research Instittue; 2013.
Lee M, Cho T, Jantaratnotai N, Wang YT, McGeer E, McGeer PL. Depletion of GSH in glial cells induces neurotoxicity: relevance to aging and degenerative neurological diseases. FASEB J. 2010 Jul;24(7):2533-45. doi: 10.1096/fj.09-149997. Epub 2010 Mar 12.
PubMed 20228251Pearce RK, Owen A, Daniel S, Jenner P, Marsden CD. Alterations in the distribution of glutathione in the substantia nigra in Parkinson's disease. J Neural Transm (Vienna). 1997;104(6-7):661-77. doi: 10.1007/BF01291884.
PubMed 9444566DelleDonne A, Klos KJ, Fujishiro H, Ahmed Z, Parisi JE, Josephs KA, Frigerio R, Burnett M, Wszolek ZK, Uitti RJ, Ahlskog JE, Dickson DW. Incidental Lewy body disease and preclinical Parkinson disease. Arch Neurol. 2008 Aug;65(8):1074-80. doi: 10.1001/archneur.65.8.1074.
PubMed 18695057
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Nervous System Uptake of Intranasal Glutathione in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02324426
- Acronym / sponsor ID
- 48273-A
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Reduced Glutathione, CNS, Glutathione, Uptake, Intranasal, (in)GSH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Dec 2014 (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.
Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles surrounding currently employed delivery methods have hindered the clinical utility of this therapy. Intranasal GSH, (in)GSH, is a novel method of glutathione augmentation. The aim of this study is to evaluate whether 200 mg of (in)GSH results in measurable changes in brain glutathione concentrations, as measured by magnetic resonance spectroscopy (MRS) in 15 individuals with PD.
Detailed description
Objectives
Primary Aim: To determine whether intranasal reduced glutathione, (in)GSH, is capable of augmenting CNS glutathione levels.
Hypothesis: Mean MRS glutathione concentration will rise from baseline following administration of 1 cc 200 mg/ml (in)GSH.
Design and Outcomes:
This pilot study seeks to obtain baseline data regarding the feasibility of MRS to detect a change in CNS glutathione concentration following administration of 200 mg (in)GSH. CNS glutathione levels will be measured using magnetic resonance spectroscopy (MRS), with the putamen as the region of interest. Baseline brain GSH concentrations will be measured by MRS at approximately the same time each day in all individuals before and after administration of study medication.
Outcome Measure: Describe the change in mean GSH concentration following administration of (in)GSH. The data analysis will be ipsative- results will be reported as percent change from the individual's own baseline GSH concentration.
Interventions and Duration:
If a participant communicates he/she understands the study, meets inclusion criteria, and provides informed consent, individuals will be scheduled for a single visit at the University of Washington for MR imaging (MRI), clinical evaluation, and blood draw. (~ 3 hours). Participants will be asked to be optimally medicated at the time of study visit, to the best of their ability.
Sample Size and Population:
This is a proof-of-concept pilot trial. Based on the data from the single test subject, a sample size of 15 would provide 80% power to detect an increase in CNS glutathione concentrations between pre- and post- administration values, if we are willing to accept an alpha value of 0.2.
1.1 Primary Aims
Primary Aim: To determine whether intranasal reduced glutathione, (in)GSH, is capable of augmenting CNS glutathione concentration. (Region of Interest: putamen)
Hypothesis: Mean MRS glutathione concentration will rise from baseline approximately 15 minutes following administration of 200 mg/ml (in)GSH in 1 cc saline.
1.2 Secondary Objectives
Hypothesis: Baseline CNS glutathione concentrations and RBC glutathione concentrations will be correlated.
- To determine whether brain MRS [glutathione] and red blood cell (RBC) glutathione levels are correlated.
Outcome: A ROC curve will be drawn between mean brain [glutathione] and RBC total glutathione.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced Glutathione | Experimental | Drug: Reduced GlutathioneThe study medication is packaged in sterile 1 ml pre-filled syringes, each containing 200 mg/ ml of reduced glutathione (GSH), which will be delivered intranasally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years.
- Ability to attend a 3 hour study visit in Seattle, WA.
- Ability to read and speak English.
- Have three or more of the required positive criteria for PD from Step 3 of the UK Brain Bank Diagnostic Criteria for Parkinson's Disease.
- A modified Hoehn \& Yahr Stage 2-3. (bilateral disease, not severely disabled.)
Key exclusion criteria (14 listed)
- Any contra-indication to magnetic resonance imaging, including pacemaker, pacemaker wires, aneurysm clip, or any electronic implant, weight over 136 kg (300 lb), metal embedded in soft tissue or in the eye, prosthetic eye, claustrophobia, substance abuse, use of recreational drugs, pregnancy, or other medical contraindications.
- A history of epilepsy, stroke, brain surgery, or structural brain disease.
- The presence of other serious illnesses (discretion of study clinician, e.g. concurrent cancer treatment.)
- Pregnant.
- A history of sulfur sensitivity, e.g. reaction N-acetylcysteine, MSM, SAMe.
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 |
|---|---|---|
| Reduced GlutathioneAlso: (in)GSH200 mg GSH delivered in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip. | Drug | Reduced Glutathione |
Primary outcome
The concentration of metabolites before and after (in)GSH will be compared (change in mean GSH concentration)
Time frame: 15 minutes after administration
Describe the change in mean GSH concentration following administration of (in)GSH. The data analysis will be ipsative- results will be reported as percent change from the individual's own baseline GSH concentration.
1 secondary outcome
A ROC curve will be generated to compare MRS [glutathione] to peripheral measures of RBC glutathione.
Time frame: 15 minutes after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Background: PubMed 7901908Coyle JT, Puttfarcken P. Oxidative stress, glutamate, and neurodegenerative disorders. Science. 1993 Oct 29;262(5134):689-95. doi: 10.1126/science.7901908.
- BackgroundMischley, L. Glutathione Deficiency in Parkinson's Disease: Intranasal Administration as a Method of Augmentation. Journal of Orthomolecular Medicine 26(1):32-36, 2011.
- Background: PubMed 9495562Bains JS, Shaw CA. Neurodegenerative disorders in humans: the role of glutathione in oxidative stress-mediated neuronal death. Brain Res Brain Res Rev. 1997 Dec;25(3):335-58. doi: 10.1016/s0165-0173(97)00045-3.
- Background: PubMed 22701755Cacciatore I, Baldassarre L, Fornasari E, Mollica A, Pinnen F. Recent advances in the treatment of neurodegenerative diseases based on GSH delivery systems. Oxid Med Cell Longev. 2012;2012:240146. doi: 10.1155/2012/240146. Epub 2012 Jun 3.
- BackgroundShils ME OJ, Shike, Moshe. Evolution of Knowledge of Essential Nutrients: Conditional Essentiality. Modern Nutrition in Health and Disease. Philadelphia: Lippincott Williams & Wilkins; 2006.
- Background: PubMed 23246994Mullins PG, McGonigle DJ, O'Gorman RL, Puts NA, Vidyasagar R, Evans CJ; Cardiff Symposium on MRS of GABA; Edden RA. Current practice in the use of MEGA-PRESS spectroscopy for the detection of GABA. Neuroimage. 2014 Feb 1;86:43-52. doi: 10.1016/j.neuroimage.2012.12.004. Epub 2012 Dec 13.
- Background: PubMed 15936251Maher P. The effects of stress and aging on glutathione metabolism. Ageing Res Rev. 2005 May;4(2):288-314. doi: 10.1016/j.arr.2005.02.005.
- Results publication: PubMed 11408093Pocernich CB, Cardin AL, Racine CL, Lauderback CM, Butterfield DA. Glutathione elevation and its protective role in acrolein-induced protein damage in synaptosomal membranes: relevance to brain lipid peroxidation in neurodegenerative disease. Neurochem Int. 2001 Aug;39(2):141-9. doi: 10.1016/s0197-0186(01)00012-2.
- Results publication: PubMed 8080242Sian J, Dexter DT, Lees AJ, Daniel S, Agid Y, Javoy-Agid F, Jenner P, Marsden CD. Alterations in glutathione levels in Parkinson's disease and other neurodegenerative disorders affecting basal ganglia. Ann Neurol. 1994 Sep;36(3):348-55. doi: 10.1002/ana.410360305.
- Results publication: PubMed 1454205Sofic E, Lange KW, Jellinger K, Riederer P. Reduced and oxidized glutathione in the substantia nigra of patients with Parkinson's disease. Neurosci Lett. 1992 Aug 17;142(2):128-30. doi: 10.1016/0304-3940(92)90355-b.
- Results publication: PubMed 8938817Sechi G, Deledda MG, Bua G, Satta WM, Deiana GA, Pes GM, Rosati G. Reduced intravenous glutathione in the treatment of early Parkinson's disease. Prog Neuropsychopharmacol Biol Psychiatry. 1996 Oct;20(7):1159-70. doi: 10.1016/s0278-5846(96)00103-0.
- Results publicationMischley LK SL, Samii A, Pollisar N, Lau R, Leverenz J, . Phase I Study of Intranasal Glutathione in Parkinson's Disease. Seattle: Bastyr University Research Instittue; 2013.
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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.
Kevin Conley, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reduced Glutathione in people with Parkinson's Disease, run by University of Washington 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 5 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 30 Apr 2015. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of metabolites before and after (in)GSH will be compared (change in mean GSH concentration) (time frame: 15 minutes after administration). 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 NCT02324426, which also lists 23 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 30 Apr 2015.