Cryptogenic Sensory Peripheral Neuropathy in Metabolic SyndromePhase 2TopCSPNNCT02878798
Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
A Phase 2 study testing topiramate in people with Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome, run by Virginia Commonwealth University at 20 sites in United States.
Trial summary
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate as a potential disease modifying therapy for cryptogenic sensory peripheral neuropathy (CSPN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome
- What is being tested?
- topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 20 sitesUnited States
- Study dates
- 12 Feb 2018to 28 Sep 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Diagnosis of confirmed symptomatic distal symmetric peripheral polyneuropathy based on the Toronto consensus criteria for probable neuropathy (the presence of unequivocal signs and symptoms of neuropathy)45.
- Evidence of symptomatic neuropathy based on a screening visit NQOL-DN score of >9.
- Metabolic syndrome based on modified ATPIII criteria. Specific criteria require 3 of the following 6 to be present at the screening visit.
- Waist circumference >102 cm for men, >88 cm for women
- Serum triglycerides of > 150 mg/dl
Show all 13Show fewer
- HDL < 40 mg/dl for men, < 50 mg/dl for women
- Those with either a normal HDL or TRG who are taking a lipid lowering medication for this purpose
- Blood pressure 130/85 mm Hg or use of anti-hypertension drug
- Hyperglycemia based on American Diabetes Association (ADA) criteria at screening based on any one or more of the following: fasting plasma glucose > 100 mg/dL (5.6 mmol/L), 2-hour glucose tolerance test > 140 mg/dL (7.8 mmol/L), or hemoglobin A1c > 5.7% .
- No current or prior history of therapy with topiramate.
- If female of child-bearing potential (i.e., not surgically sterile or post-menopausal defined as age > 51 years without menses for ≥ 2 years), negative serum pregnancy test at screening and negative urine pregnancy test at baseline visit.
- Women of child-bearing potential or men with sexual partners of childbearing potential be willing to use an acceptable method of birth control for the duration of the study and for 12 weeks following completion of study drug therapy. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, intra-uterine device, the contraceptive ring, and or barrier contraception such as condoms with spermicide.
Who cannot join
- CSS-PI clinical determination of an alternative cause for peripheral neuropathy (including but not limited to rheumatological disorders, Hepatitis B or C, breast cancer treated with neurotoxic chemotherapy within the past 15 years). All potential subjects will have screening neuropathy labs including assessment for diabetes (Hemoglobin A1c, oral glucose tolerance test), vitamin B12 level, and immunofixation47.
- Type I diabetes or current use of insulin or use of insulin in the past 3 months.
- HgA1c > 7.5%. Borderline screening labs can be repeated within two weeks with PPI approval.
- History of recurrent nephrolithiasis, a single episode of nephrolithiasis within one year prior to screening, or use of ongoing preventative treatment.
- Family history of a hereditary neuropathy in a first-degree relative.
- Severe neuropathy: Utah Early Neuropathy Score > 24 at screening
Show all 29Show fewer
- Active foot ulceration or a history of a nontraumatic foot amputation.
- ECG with QTc more than 450 ms in men, or 470 ms in women.
- Risk of excessive bleeding at the skin biopsy site based on the clinical assessment of the CSS-PI.
- Chronic corticosteroid use excluding topical or inhaled treatment.
- Use of a carbonic anhydrase inhibitor (such as acetazolamide) due to risk of nephrolithiasis.
- Planned bariatric surgery.
- Use of other weight loss medications.
- Use of scheduled opiates, or as needed opiate medications more than three times weekly.
- Use of topical capsaicin products within 16 weeks of screening or at any time on study.
- Medication change for neuropathy symptoms during the 8 weeks prior to screening; or anticipated change for the duration of study participation.
- Current use of an intrathecal pain pump or spinal cord stimulator.
- Screening laboratory creatinine ≥ 2.0 mg/dl.
- Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy.
- Major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neuropathy assessment in the opinion of the responsible site principal investigator.
- Current suicidal ideation within one year prior to the baseline visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Ataxia sufficiently severe to represent an unacceptable fall risk in the opinion of the site principal investigator.
- A serious medical condition expected to dramatically shorten life span or prevent participation.
- Any clinically significant condition or illness, which, in the opinion of the CSS-PI, would pose a risk to the subject or might confound the study including metabolic acidosis, bone marrow suppression, blood dyscrasias, bleeding disorder, or closed angle glaucoma.
- History of alcohol or drug abuse within the past two years, or existing neuropathy related to past drug or alcohol abuse.
- History of malignancy within five years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- A history of epilepsy.
- An inability to understand or cooperate with the procedures of the study.
- Pregnant, or intending to become pregnant, or breastfeeding.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Michigan Neurology Clinical Trials Organization
Ann Arbor, Michigan, 48105-2945
University of Alabama Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43221
UT Southwestern Medical Center
Dallas, Texas, 75390
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Medical Center
New York, New York, 10032
Eastern Virginia Medical Center
Norfolk, Virginia, 23510
University of California Irvine
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Barrow Neurological Institute
Phoenix, Arizona, 85013
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Rochester Medical Center
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84132
Washington University School of Medicine
St Louis, Missouri, 63110
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Topiramate as a Disease Modifying Therapy for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate as a potential disease modifying therapy for cryptogenic sensory peripheral neuropathy (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do not have an alternative cause for neuropathy will be potentially eligible. The co primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase will last 24 months.
- Being tested
- topiramate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topiramateDrug
Also called Topamax
Oral topiramate at a target dose of 50mg twice daily.
PlaceboOther
overencapsulated placebo of identical color, shape and packaging to topiramate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | An overencapsulated placebo of identical color, shape and packaging to topiramate will be used. Receives: Other: Placebo |
| Topiramate | Experimental | Oral topiramate Receives: Drug: topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraepidermal Nerve Fiber Density (IENFD)
Difference in IENFD change between treatment groups over 96 weeks (fibers/mm) (i.e. the slope of change). A skin biopsy is obtained. The sample is stained for nerve fibers. The rate of change in IENFD in fibers/mm is calculated over the 96 week duration of the study and expressed in change in fibers/mm/year (defined as 52 weeks) over the study period (i.e. the slope of change expressed and change in IENFD in fibers/mm over a 52 week period).
Measured: 96 weeks
Norfolk Quality of Life - Diabetic Neuropathy
Difference in NQOL between treatment groups over 96 weeks. The Norfolk QOL-DN is a validated 47-item, patient-reported outcome measure, sensitive to the different features of diabetic neuropathy (DN) including small fiber, large fiber, and autonomic function. A lower score is better. The range of the score is from -4 to 136. The slope of the change in total Norfolk QOL-DD is calculated as the change in total score/52 weeks (one year)
Measured: 96 weeks (expressed as a slope in change of total score/52 weeks)
Secondary outcomes (10)
Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference
Pain interference score. Each item is scored from 0-10 with a total possible number of points of 70, higher worse. The range of the score is 0-70. The change in score is expressed as a slope of change in pain interference score/52 weeks (one year)
Measured: 96 weeks (expressed as a change in change in pain interference/52weeks)
Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity
Average pain severity. Each item is scored 0-10 with a total of 40 possible points, higher is worse. The range of the score is 0-40. The slope of the change in this score is expressed as change/one year (defined as 52 weeks)
Measured: 96 weeks (expressed as a slope of change over 52 weeks)
Utah Early Neuropathy Scale
The UENS is a validated examination score of neuropathy severity based on a physical examination (Singleton et al 2008). Total score is 42 (minimum 0 and maximum 42). The higher the score, the worse the outcome is. The change in UENS over the 96 week period is expressed as a slope of change in total UENS over one year defined as 52 weeks.
Measured: 96 weeks (expressed as a slope of change in total UENS over 52 weeks).
Sural Sensory Amplitude (SSA)
Change in SSA measured in microvolts. SSA is measured by electrically stimulating a nerve through the skin and recording the response. A larger value is better. The normal values vary based on age, with a minimum of 0 (absent). Across all ages, the lower limit of normal is 6 microvolts, although the normal cutoff declines with aging. The change in SSA over the 96 week study period is expressed as a slope of change in uV/52 weeks (the 52 week log (mV) change of non-zero values).
Measured: 96 weeks (slope of change in mV/52weeks)
Peroneal Motor Conduction Velocity (PMCV)
PMCV change. PMCV is measured by electrically stimulating the nerve through the skin at two different locations and measuring how fast the response travels between the two in meters/second. A higher value is better. The slope of the change in PMCV is expressed as change in meters/second/52 weeks (one year).
Measured: 96 weeks (expressed as a slope of change in meter/sec over 52 weeks)
Body Mass Index (BMI)
BMI change in kg/m2. BMI is a measure of weight relative to height. The slope of the change in BMI over the study was expressed as change in kg/m2/52 weeks.
Measured: 96 weeks (slope of change in kg/m2/52 weeks)
Hemoglobin A1C
Slope of the Hemoglobin A1C change. A1C is measured in percent. It provides an estimate of how high blood sugar has been over the past three months. A higher value indicates poor diabetic control.
Measured: The annual slope of the change in A1C over 96 weeks expressed in change in percent/52 weeks
Serum Triglycerides (TRG)
TRG change. TRG are a type of lipid or fat circulating in the blood. A higher value is associated with increased cardiovascular risk. The slope of the change in TRG was calculated as change in mg/dl over 52 weeks (one year).
Measured: 96 weeks (slope of change mg/dl over 52 weeks)
LDL Cholesterol
LDL change. LDL is "bad" cholesterol, measured in mg/dL. A higher value is associated with elevated cardiovascular risk. A slope of change is calculated change in LDL in mg/dL/52 weeks (one year)
Measured: 96 weeks (expressed as a slope of change in mg/dl/52 weeks)
HDL Cholesterol
HDL change. HDL is "good cholesterol", measured in mg/dL. A lower value is associated with higher cardiovascular risk. The slope of change is calculated as change in mg/dL/52 weeks (one year)
Measured: 96 weeks (expressed as slope of change in mg/dL/52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start12 Feb 2018
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for Cryptogenic Sensory Peripheral Neuropathy in Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), NeuroNEXT Network
- Responsible party
- Sponsor
- Investigators
- Gordon Smith, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878798
- Sponsor's protocol ID
- URNN001 / HM20014083
- Other IDs
- 1U01NS095388
- Acronym
- TopCSPN
- Status last verified
- Oct 2023
- First submitted
- 11 Aug 2016
- Last updated
- 14 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Smith AG, Singleton JR, Aperghis A, Coffey CS, Creigh P, Cudkowicz M, Conwit R, Ecklund D, Fedler JK, Gudjonsdottir A, Hauer P, Herrmann DN, Kearney M, Kissel J, Klingner E, Quick A, Revere C, Stino A; NeuroNEXT NN108 TopCSPN Study Team. Safety and Efficacy of Topiramate in Individuals With Cryptogenic Sensory Peripheral Neuropathy With Metabolic Syndrome: The TopCSPN Randomized Clinical Trial. JAMA Neurol. 2023 Dec 1;80(12):1334-1343. doi: 10.1001/jamaneurol.2023.3711.
PubMed 37870862
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate as a Disease Modifying Therapy for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
- ClinicalTrials.gov ID
- NCT02878798
- Acronym / sponsor ID
- TopCSPN / URNN001 / HM20014083
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), NeuroNEXT Network
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Posted 14 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate as a potential disease modifying therapy for cryptogenic sensory peripheral neuropathy (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do not have an alternative cause for neuropathy will be potentially eligible. The co primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase will last 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboAn overencapsulated placebo of identical color, shape and packaging to topiramate will be used. |
| Topiramate | Experimental | Drug: topiramateOral topiramate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-80
- Diagnosis of confirmed symptomatic distal symmetric peripheral polyneuropathy based on the Toronto consensus criteria for probable neuropathy (the presence of unequivocal signs and symptoms of neuropathy)45.
- Evidence of symptomatic neuropathy based on a screening visit NQOL-DN score of >9.
- Metabolic syndrome based on modified ATPIII criteria. Specific criteria require 3 of the following 6 to be present at the screening visit.
- No current or prior history of therapy with topiramate.
Key exclusion criteria (29 listed)
- CSS-PI clinical determination of an alternative cause for peripheral neuropathy (including but not limited to rheumatological disorders, Hepatitis B or C, breast cancer treated with neurotoxic chemotherapy within the past 15 years). All potential subjects will have screening neuropathy labs including assessment for diabetes (Hemoglobin A1c, oral glucose tolerance test), vitamin B12 level, and immunofixation47.
- Type I diabetes or current use of insulin or use of insulin in the past 3 months.
- HgA1c > 7.5%. Borderline screening labs can be repeated within two weeks with PPI approval.
- History of recurrent nephrolithiasis, a single episode of nephrolithiasis within one year prior to screening, or use of ongoing preventative treatment.
- Family history of a hereditary neuropathy in a first-degree relative.
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 |
|---|---|---|
| topiramateAlso: TopamaxOral topiramate at a target dose of 50mg twice daily. | Drug | Topiramate |
| Placebooverencapsulated placebo of identical color, shape and packaging to topiramate | Other | Placebo |
Primary outcome
Intraepidermal Nerve Fiber Density (IENFD)
Time frame: 96 weeks
Difference in IENFD change between treatment groups over 96 weeks (fibers/mm) (i.e. the slope of change). A skin biopsy is obtained. The sample is stained for nerve fibers. The rate of change in IENFD in fibers/mm is calculated over the 96 week duration of the study and expressed in change in fibers/mm/year (defined as 52 weeks) over the study period (i.e. the slope of change expressed and change in IENFD in fibers/mm over a 52 week period).
Norfolk Quality of Life - Diabetic Neuropathy
Time frame: 96 weeks (expressed as a slope in change of total score/52 weeks)
Difference in NQOL between treatment groups over 96 weeks. The Norfolk QOL-DN is a validated 47-item, patient-reported outcome measure, sensitive to the different features of diabetic neuropathy (DN) including small fiber, large fiber, and autonomic function. A lower score is better. The range of the score is from -4 to 136. The slope of the change in total Norfolk QOL-DD is calculated as the change in total score/52 weeks (one year)
10 secondary outcomes
Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference
Time frame: 96 weeks (expressed as a change in change in pain interference/52weeks)
Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity
Time frame: 96 weeks (expressed as a slope of change over 52 weeks)
Utah Early Neuropathy Scale
Time frame: 96 weeks (expressed as a slope of change in total UENS over 52 weeks).
Sural Sensory Amplitude (SSA)
Time frame: 96 weeks (slope of change in mV/52weeks)
Peroneal Motor Conduction Velocity (PMCV)
Time frame: 96 weeks (expressed as a slope of change in meter/sec over 52 weeks)
Body Mass Index (BMI)
Time frame: 96 weeks (slope of change in kg/m2/52 weeks)
Hemoglobin A1C
Time frame: The annual slope of the change in A1C over 96 weeks expressed in change in percent/52 weeks
Serum Triglycerides (TRG)
Time frame: 96 weeks (slope of change mg/dl over 52 weeks)
LDL Cholesterol
Time frame: 96 weeks (expressed as a slope of change in mg/dl/52 weeks)
HDL Cholesterol
Time frame: 96 weeks (expressed as slope of change in mg/dL/52 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37870862Smith AG, Singleton JR, Aperghis A, Coffey CS, Creigh P, Cudkowicz M, Conwit R, Ecklund D, Fedler JK, Gudjonsdottir A, Hauer P, Herrmann DN, Kearney M, Kissel J, Klingner E, Quick A, Revere C, Stino A; NeuroNEXT NN108 TopCSPN Study Team. Safety and Efficacy of Topiramate in Individuals With Cryptogenic Sensory Peripheral Neuropathy With Metabolic Syndrome: The TopCSPN Randomized Clinical Trial. JAMA Neurol. 2023 Dec 1;80(12):1334-1343. doi: 10.1001/jamaneurol.2023.3711.
- Individual participant dataSharing planned: Undecided
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.
Gordon Smith, MD principal investigator
Virginia Commonwealth University
20 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 topiramate in people with Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome, run by Virginia Commonwealth University at 20 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 13 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 14 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 20 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 14 Nov 2023). 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?
Intraepidermal Nerve Fiber Density (IENFD) (time frame: 96 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02878798, which also lists 1 linked publication.
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 14 Nov 2023.