Metabolic Syndrome XPhase 2ARCH-MSNCT00455325
Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)
A Phase 2 study testing Active Comparator: Second Intervention (3 weeks), Active Comparator: Third Intervention (3 weeks) and Active Comparator: Fourth Intervention (3 weeks) in people with Metabolic Syndrome X and Overweight, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Metabolic syndrome consists of a group of co-occuring conditions that increase an individual's risk of developing heart disease, stroke, and diabetes. The purpose of this study is to evaluate the short-term effectiveness of chloroquine, a protein-activation medication, at improving metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome X, Overweight, Hypertension
- What is being tested?
- Active Comparator: Second Intervention (3 weeks), Active Comparator: Third Intervention (3 weeks) and Active Comparator: Fourth Intervention (3 weeks)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Mar 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of metabolic syndrome, as determined by at least three of the following five criteria:
- Elevated fasting triglyceride levels greater than or equal to 150 mg/dL
- Low HDL cholesterol levels: less than 50 mg/dL for women and less than 40 mg/dL for men
- Hypertension (=>130/85 mm Hg =<160/100 mm Hg) untreated; or hypertension controlled (=<150/90 mm Hg) on a stable medication regimen for 4 weeks prior to baseline visit.
- Increased waist circumference: greater than 35 inches in women and greater than 40 inches in men
- Elevated fasting glucose levels =<100 mg/dL but =>126 mg/dL
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- Subjects may be on a stable doses of a statin drug for at least 3 months
- Subjects may be on a stable doses of L-thyroxine for at least 3 months
- Willing to use acceptable form of birth control (e.g., hormonal birth control, double barrier methods)
Who cannot join
- Prior travel treatment with chloroquine or hydroxychloroquine as follows:
- any exposure in the past 2 years,
- >30 days of therapy if exposure was between 2 and 5 years ago,
- >90 days of therapy if exposure was between 5 and 10 years ago,
- >6 months of therapy if exposure was 10 to 20 years ago,
- >1 year of therapy if exposure was 20 to 30 years ago,
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- No limit if last exposure was >30 years ago, ex. during the Vietnam conflict.
- Morbid obesity (body mass index [BMI] greater than 45)
- Coronary artery disease or other vascular disease
- History of stroke
- Chronic kidney insufficiency (i.e.,estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2)
- Diabetes
- Seizure disorder
- History of psoriasis
- Blood disorders, including anemia (i.e., hemoglobin levels less than 13 g/dL in men and less than 12 g/dL in women)
- Current malignancy or active treatment for recurrence prevention, example tamoxifen. Cancer considered to be cured, either as a result of surgery or other treatment is not exclusionary.
- Asthma requiring daily beta agonist therapy or intermittent oral steroids is exclusionary. Inhaled steroids are acceptable. Obstructive sleep apnea will be allowed if Continuous Positive Airway Pressure (CPAP) or other therapy has been stable for 6 months. Other active respiratory diseases are excluded.
- Liver disease, or liver function test results greater than twice the normal value
- Active infection, including HIV
- Serious illness requiring ongoing medical care or medication
- Treatment with atypical anti-psychotic medication. Treatment with any other medication for psychiatric illness, unless on a stable dose for 6 weeks prior to enrollment. Patients with unstable psychiatric disorders are excluded per the decision of the study MD regardless of medication history.
- Taking any of the following lipid lowering medications: niacin, fibrates, and greater than 1 gm fish oils
- Uncontrolled hypertension (BP >150/90) at enrollment.
- Need for daily over the counter medications, or currently taking cimetidine or >1000 IU vitamin E daily and unwilling to reduce or discontinue the use of vitamin E or discontinue cimetidine for the duration of the study. Persons taking >1000 IU of vitamin E should reduce the dose 30 days prior to randomization.
- Pregnant, breastfeeding, or intending to become pregnant
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Retinal disease (in particular, drusen or pigmentary changes at the macula); any ocular disease that interferes with the eye examination (e.g., cataracts)
- Auditory disease or hearing loss; persons with total, irreversible hearing loss can be enrolled.
- Participation in another clinical trial within past 30 days prior to screening and 60 days prior to randomization. Questionnaire or observational studies are not exclusionary.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Genotoxic Stress, Atherosclerosis, and Metabolic Syndrome-AIM 2
Metabolic syndrome consists of a group of co-occuring conditions that increase an individual's risk of developing heart disease, stroke, and diabetes. The purpose of this study is to evaluate the short-term effectiveness of chloroquine, a protein-activation medication, at improving metabolic syndrome.
Read the detailed description
Metabolic syndrome is one of the most common disorders in industrialized countries. It consists of abnormal serum lipids, glucose intolerance, elevated blood pressure, and central obesity in the setting of insulin resistance. The syndrome substantially increases the risk of developing diabetes and vascular disease, but there is no clear unifying approach to treat this disorder. In animals, activation of the protein ataxia telangiectasia mutated (ATM) using the antimalarial drug chloroquine improves features of metabolic syndrome and decreases atherosclerosis, a build-up of fatty plaque within arteries. The purpose of this study is to evaluate the effectiveness of short-term treatment with low doses of chloroquine as a way of managing metabolic syndrome.
Participants in this study will initially receive placebo for 3 weeks, followed by increasing doses of chloroquine in three, 3-week intervals. Following each 3-week treatment, participants will be admitted to the research center for one day. There will be a period of no active treatment for 5 to 7 weeks following each admission to the research center to allow recovery from the blood drawing of the clamp procedure before the start of the next treatment interval.
- Conditions
- Metabolic Syndrome X, Overweight, Hypertension, Dyslipidemias, Prediabetic State
- Being tested
- Placebo Comparator: First Intervention (3 weeks), Active Comparator: Second Intervention (3 weeks), Active Comparator: Third Intervention (3 weeks), Active Comparator: Fourth Intervention (3 weeks)
- Keywords
- Insulin Resistance, Atherosclerosis, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome, Overweight, Hypertension, Dyslipidemias, Prediabetic State, Insulin Resistance, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Comparator: First Intervention (3 weeks)Drug
Also called Placebo once daily
once daily placebo tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
Active Comparator: Second Intervention (3 weeks)Drug
Also called 80 mg chloroquine or placebo tablet once daily
Once daily 80mg chloroquine or placebo tablet 3 Weeks followed by euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
Active Comparator: Third Intervention (3 weeks)Drug
Also called 80 mg chloroquine tablet once daily
Once daily 80mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
Active Comparator: Fourth Intervention (3 weeks)Drug
Also called 250 mg chloroquine tablet once daily
Once daily 250mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
| Study group | Role | What they receive |
|---|---|---|
| First Intervention (3 weeks) | Placebo comparator | Cohort 1: Chloroquine placebo one tablet daily for 3 weeks, followed by 5-7 week rest period. Receives: Drug: Placebo Comparator: First Intervention (3 weeks) |
| Second Intervention (3 weeks) | Active comparator | Cohort 2: 80mg chloroquine or placebo tablet once daily for Weeks 3, followed by 5-7 week rest period. Receives: Drug: Active Comparator: Second Intervention (3 weeks) |
| Third Intervention (3 weeks) | Active comparator | Cohort 3: 80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period. Receives: Drug: Active Comparator: Third Intervention (3 weeks) |
| Fourth Intervention (3 weeks) | Active comparator | Cohort 4: 250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period. Receives: Drug: Active Comparator: Fourth Intervention (3 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Hepatic insulin sensitivity was measured by comparing glucose production at baseline of zero insulin infusion rate with glucose production at 56 pmol/m2/min. Hepatic insulin sensitivity was expressed as the percent suppression, such that greater percent suppression indicated greater hepatic insulin sensitivity. There are no reference values, since the patients served as their own controls.
Measured: assessed every 8 - 10 weeks at the end of each treatment period
Secondary outcomes (6)
Systolic Blood Pressure
Two techniques were employed: auscultation of seated subjects at rest was performed by a trained observer who recorded the first and fifth phases of the Korotkoff sounds; and, a portable oscillometric device (SpaceLabs Medical) recorded results every 20 min during the day and every hour during the night. Data were analyzed as mean values over 24 hours.
Measured: Assessed every 8-10 weeks at the end of each treatment period
Diastolic Blood Pressure
Two techniques were employed: auscultation of seated subjects at rest was performed by a trained observer who recorded the first and fifth phases of the Korotkoff sounds; and, a portable oscillometric device (SpaceLabs Medical) recorded results every 20 min during the day and every hour during the night. Data were analyzed as mean values over 24 hours.
Measured: Assessed every 8-10 weeks at the end of each treatment period.
Total Cholesterol
Fasting Serum Blood Sample
Measured: Assessed every 8-10 weeks at the end of each treatment period.
Non-HDL Cholesterol
Fasting Serum Blood Sample
Measured: Assessed every 8-10 weeks at the end of each treatment period.
Low-density Lipoprotein
Fasting Serum Blood Sample
Measured: Assessed every 8-10 weeks at the end of each treatment period.
Triglycerides
Fasting Serum Blood Sample
Measured: Assessed every 8-10 weeks at the end of each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startSep 2004
- Primary completionJun 2010
- Study completionMar 2012
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 (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by Washington University School 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Clay F. Semenkovich, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455325
- Sponsor's protocol ID
- 395
- Other IDs
- P50HL083762
- Acronym
- ARCH-MS
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2007
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schneider JG, Finck BN, Ren J, Standley KN, Takagi M, Maclean KH, Bernal-Mizrachi C, Muslin AJ, Kastan MB, Semenkovich CF. ATM-dependent suppression of stress signaling reduces vascular disease in metabolic syndrome. Cell Metab. 2006 Nov;4(5):377-89. doi: 10.1016/j.cmet.2006.10.002.
PubMed 17084711McGill JB, Johnson M, Hurst S, Cade WT, Yarasheski KE, Ostlund RE, Schechtman KB, Razani B, Kastan MB, McClain DA, de las Fuentes L, Davila-Roman VG, Ory DS, Wickline SA, Semenkovich CF. Low dose chloroquine decreases insulin resistance in human metabolic syndrome but does not reduce carotid intima-media thickness. Diabetol Metab Syndr. 2019 Jul 29;11:61. doi: 10.1186/s13098-019-0456-4. eCollection 2019.
PubMed 31384309Razani B, Feng C, Semenkovich CF. p53 is required for chloroquine-induced atheroprotection but not insulin sensitization. J Lipid Res. 2010 Jul;51(7):1738-46. doi: 10.1194/jlr.M003681. Epub 2010 Mar 5.
PubMed 20208057
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotoxic Stress, Atherosclerosis, and Metabolic Syndrome-AIM 2
- ClinicalTrials.gov ID
- NCT00455325
- Acronym / sponsor ID
- ARCH-MS / 395
- Conditions
- Metabolic Syndrome X, Overweight, Hypertension, Dyslipidemias, Prediabetic State
- Keywords
- Insulin Resistance, Atherosclerosis, Metabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Apr 2007 (estimated)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic syndrome consists of a group of co-occuring conditions that increase an individual's risk of developing heart disease, stroke, and diabetes. The purpose of this study is to evaluate the short-term effectiveness of chloroquine, a protein-activation medication, at improving metabolic syndrome.
Detailed description
Metabolic syndrome is one of the most common disorders in industrialized countries. It consists of abnormal serum lipids, glucose intolerance, elevated blood pressure, and central obesity in the setting of insulin resistance. The syndrome substantially increases the risk of developing diabetes and vascular disease, but there is no clear unifying approach to treat this disorder. In animals, activation of the protein ataxia telangiectasia mutated (ATM) using the antimalarial drug chloroquine improves features of metabolic syndrome and decreases atherosclerosis, a build-up of fatty plaque within arteries. The purpose of this study is to evaluate the effectiveness of short-term treatment with low doses of chloroquine as a way of managing metabolic syndrome.
Participants in this study will initially receive placebo for 3 weeks, followed by increasing doses of chloroquine in three, 3-week intervals. Following each 3-week treatment, participants will be admitted to the research center for one day. There will be a period of no active treatment for 5 to 7 weeks following each admission to the research center to allow recovery from the blood drawing of the clamp procedure before the start of the next treatment interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First Intervention (3 weeks) | Placebo comparator | Drug: Placebo Comparator: First Intervention (3 weeks)Cohort 1: Chloroquine placebo one tablet daily for 3 weeks, followed by 5-7 week rest period. |
| Second Intervention (3 weeks) | Active comparator | Drug: Active Comparator: Second Intervention (3 weeks)Cohort 2: 80mg chloroquine or placebo tablet once daily for Weeks 3, followed by 5-7 week rest period. |
| Third Intervention (3 weeks) | Active comparator | Drug: Active Comparator: Third Intervention (3 weeks)Cohort 3: 80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period. |
| Fourth Intervention (3 weeks) | Active comparator | Drug: Active Comparator: Fourth Intervention (3 weeks)Cohort 4: 250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Diagnosis of metabolic syndrome, as determined by at least three of the following five criteria:
- Subjects may be on a stable doses of a statin drug for at least 3 months
- Subjects may be on a stable doses of L-thyroxine for at least 3 months
- Willing to use acceptable form of birth control (e.g., hormonal birth control, double barrier methods)
Key exclusion criteria (29 listed)
- Prior travel treatment with chloroquine or hydroxychloroquine as follows:
- Morbid obesity (body mass index [BMI] greater than 45)
- Coronary artery disease or other vascular disease
- History of stroke
- Chronic kidney insufficiency (i.e.,estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2)
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 |
|---|---|---|
| Placebo Comparator: First Intervention (3 weeks)Also: Placebo once dailyonce daily placebo tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells | Drug | First Intervention (3 weeks) |
| Active Comparator: Second Intervention (3 weeks)Also: 80 mg chloroquine or placebo tablet once dailyOnce daily 80mg chloroquine or placebo tablet 3 Weeks followed by euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells | Drug | Second Intervention (3 weeks) |
| Active Comparator: Third Intervention (3 weeks)Also: 80 mg chloroquine tablet once dailyOnce daily 80mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells | Drug | Third Intervention (3 weeks) |
| Active Comparator: Fourth Intervention (3 weeks)Also: 250 mg chloroquine tablet once dailyOnce daily 250mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells | Drug | Fourth Intervention (3 weeks) |
Primary outcome
Insulin Sensitivity
Time frame: assessed every 8 - 10 weeks at the end of each treatment period
Hepatic insulin sensitivity was measured by comparing glucose production at baseline of zero insulin infusion rate with glucose production at 56 pmol/m2/min. Hepatic insulin sensitivity was expressed as the percent suppression, such that greater percent suppression indicated greater hepatic insulin sensitivity. There are no reference values, since the patients served as their own controls.
6 secondary outcomes
Systolic Blood Pressure
Time frame: Assessed every 8-10 weeks at the end of each treatment period
Diastolic Blood Pressure
Time frame: Assessed every 8-10 weeks at the end of each treatment period.
Total Cholesterol
Time frame: Assessed every 8-10 weeks at the end of each treatment period.
Non-HDL Cholesterol
Time frame: Assessed every 8-10 weeks at the end of each treatment period.
Low-density Lipoprotein
Time frame: Assessed every 8-10 weeks at the end of each treatment period.
Triglycerides
Time frame: Assessed every 8-10 weeks at the end of each treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17084711Schneider JG, Finck BN, Ren J, Standley KN, Takagi M, Maclean KH, Bernal-Mizrachi C, Muslin AJ, Kastan MB, Semenkovich CF. ATM-dependent suppression of stress signaling reduces vascular disease in metabolic syndrome. Cell Metab. 2006 Nov;4(5):377-89. doi: 10.1016/j.cmet.2006.10.002.
- Derived from this study: PubMed 31384309McGill JB, Johnson M, Hurst S, Cade WT, Yarasheski KE, Ostlund RE, Schechtman KB, Razani B, Kastan MB, McClain DA, de las Fuentes L, Davila-Roman VG, Ory DS, Wickline SA, Semenkovich CF. Low dose chloroquine decreases insulin resistance in human metabolic syndrome but does not reduce carotid intima-media thickness. Diabetol Metab Syndr. 2019 Jul 29;11:61. doi: 10.1186/s13098-019-0456-4. eCollection 2019.
- Derived from this study: PubMed 20208057Razani B, Feng C, Semenkovich CF. p53 is required for chloroquine-induced atheroprotection but not insulin sensitization. J Lipid Res. 2010 Jul;51(7):1738-46. doi: 10.1194/jlr.M003681. Epub 2010 Mar 5.
- click here for Washington University Research Participant RegistryLink provided by the sponsor.
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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.
Clay F. Semenkovich, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Comparator: Second Intervention (3 weeks), Active Comparator: Third Intervention (3 weeks) and Active Comparator: Fourth Intervention (3 weeks) in people with Metabolic Syndrome X and Overweight, run by Washington University School of Medicine 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 9 inclusion and 29 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 10 May 2022). 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?
Insulin Sensitivity (time frame: assessed every 8 - 10 weeks at the end of each treatment period). 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 NCT00455325, which also lists 3 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 10 May 2022.