Parkinson's Disease DementiaPhase 2NCT03413384
To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia
A Phase 2 study testing Ceftriaxone in people with Parkinson's Disease Dementia, run by BrainX Corporation at 6 sites in Taiwan.
Trial summary
This is a randomized, double blinded, placebo-controlled Phase II study to investigate the efficacy and safety of ceftriaxone in patients with mild to moderate Parkinson's disease dementia (PDD).This study will enroll approximately 106 patients to have up to 84 evaluable subjects, and conduct in Chung Shan Medical… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson's Disease Dementia
- What is being tested?
- Ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesTaiwan
- Study dates
- 15 Feb 2019to 13 Mar 2026
- Phase
- Phase 2
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are male or female, age 50-85 years, inclusive.
- Diagnosis of idiopathic Parkinson's disease (PD) based on the UK Parkinson's Disease Society Brain Bank Criteria and with a modified Hoehn and Yahr Stage of I to IV.
- Patients have been receiving stable dose of medications equivalent up to 1800 mg/day of levodopa for Parkinson's disease at least 2 weeks prior to screening and patients are considered as being optimally treated at screening and no known further adjustments of current medication needed to improve the subject's status of PD during the study period by the judgment of the Investigator based on the subject's history, previous treatments, and the clinical presentation.
- Diagnosis of PDD based on Movement Disorder Society (MDS) Task Force criteria as the following items:
- A diagnosis of PD based on UK Parkinson's Disease Society Brain Bank Criteria
- PD development prior to the onset of dementia based on patient/caregiver history or records
Show all 16Show fewer
- Cognitive deficiency severe enough to impair daily life based on patient/caregiver interview or questionnaire
- Impairment of at least 2 of the following domains: attention, executive function, visuo-constructive ability, memory Besides, patients' Mini-Mental State Examination (MMSE) should be in the range of 18-25 (inclusive) or CDR scale in the range of 0.5-2. Note that MMSE range 16-25 for illiterate. Illiterate is defined as no education history.
- Patients who are eligible and able to participate in the study must be judged by the investigator to evaluate the competency of providing informed consent for this dementia related study (the decision making is based on MacArthur Competence Assessment concept) and should be able to understand the language in which the tests require so and must be able to perform all the assessments.
- All male and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods shown below, for during and at least 4 weeks after ceftriaxone treatment.
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
- Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):
- d.1 Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Who cannot join
- Any indication of forms of Parkinsonism other than idiopathic PD.
- Diagnosis of possible PDD.
- Diagnosis of dementia with Lewy Bodies.
- Mental/physical/social condition which could preclude performing efficacy or safety assessments.
- Medical history of brain or other clinically significant neurological/psychiatric disorders or injuries other than PD or PDD that would hinder or interfere the study safety or efficacy evaluation in the opinion of the Investigator.
- The patients have received neurosurgical intervention related to PD (e.g. deep brain stimulation (DBS), thalamotomy etc.) or are scheduled to do so during the trial period.
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- The patients have history of allergic response to levodopa, ceftriaxone, cephalosporin class of drugs or ursodiol or lidocaine.
- Malignant neoplastic disease, either currently active or in remission for less than 1 year.
- Clinically significant and unstable gastrointestinal, renal, endocrine, pulmonary, or cardiovascular disease, including not well controlled hypertension, asthma, chronic obstructive pulmonary disease, diabetes, hyperbilirubinemia, impaired vitamin K synthesis or low vitamin K stores that would hinder or interfere participation to the study in the opinion of the Investigator.
- Patients with abdominal ultrasound examination imaging shows active biliary obstruction disease at PI's discretion during screening.
- The patients are currently experiencing unpredictable or intractable or troublesome dyskinesia or fluctuations in their symptoms.
- Patients with the following medications that could put patients at risk, interfere with study evaluations, or prevent meeting the requirements of the study at the judgement of PI should be excluded :
- Centrally acting anticholinergic medication currently or within 4 weeks prior to the screening visit.
- Cocaine, opioids, ethanol (binge drinking or heavy alcohol defined by SAMHSA and NIAAA) currently or within 4 weeks prior to the screening visit; amphetamines, cannabinoids abuse history or taking currently or within 3 months prior to the screening visit.
- Acetylcholinesterase inhibitors or memantine currently or within 4 weeks prior to the screening visit, except that patients have been stable controlled and have been receiving stable dose of the acetylcholinesterase inhibitors or memantine for at least 4 weeks prior to screening or are considered being optimally treated at screening without further dose adjustments needed as judged by the Investigator.
- Ceftriaxone or cephalosporin or penicillin or β-lactam currently or within 4 weeks prior to the screening visit.
- Neuroleptics or antipsychotics for treatment of psychotic symptoms (e.g., hallucinations) within 4 weeks prior to the screening visit, except that patients have been stable controlled and have been receiving stable dose of the neuroleptics or antipsychotics for at least 4 weeks prior to screening or are considered being optimally treated at screening without further dose adjustments needed as judged by the Investigator.
- A drug that has severe hepatotoxic or renal toxic within 4 weeks prior to the screening visit.
- Warfarin, cyclosporin, vancomycin, amsacrine, aminoglycosides, fluconazole, chloramphenicol currently or within 4 weeks prior to the screening visit.
- Currently participating in another clinical trial or who participated in a previous clinical trial and received any investigational product treatment within 4 weeks prior to the screening visit.
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer from such.
- Patients who are not able to take MRI and TRODAT SPECT examination.
- Patients who are pregnant or breast feeding.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Changhua Christian Hospital
Changhua, 500
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Kaohsiung, 83301
Chung Shan Medical University Hospital
Taichung, Taichung, 402
China Medical University Hospital
Taichung, Taichung, 404
National Taiwan University Hospital
Taipei, Taipei, 100
Taipei Veterans General Hospital
Taipei, Taipei, 11217
About this study
Official title: A Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia
This is a randomized, double blinded, placebo-controlled Phase II study to investigate the efficacy and safety of ceftriaxone in patients with mild to moderate Parkinson's disease dementia (PDD).This study will enroll approximately 106 patients to have up to 84 evaluable subjects, and conduct in Chung Shan Medical University Hospital, National Taiwan University Hospital, Kaohsiung Chang Gung Memorial Hospital, China Medical University Hospital, Changhua Christian Hospital, and Taipei Veterans General Hospital.
Read the detailed description
Parkinson's disease (PD) is a common neurodegenerative disorder that can cause significant disability and decrease quality of life. It is a chronic and progressive disease which means the symptoms become worse over time.
Parkinson's disease dementia (PDD) is a decline in thinking and reasoning that develops in many people living with PD at least a year after diagnosis. An estimated 50 to 80 percent of patients with PD eventually experience dementia as the disease progresses. Ceftriaxone is a kind of antibiotics, which has been marketed in many countries. This is the first time for ceftraxone treatment on PDD patient. The primary objective of this Phase II study is to evaluate the improvement of cognitive function in PDD patients with ceftriaxone administration.
This study will enroll approximately 106 patients, and conduct in multiple hospitals in Taiwan. Recruitment number of each site will be adjusted according to its enrollment status under the competitive enrollment model. Subjects will receive either ceftriaxone or placebo in a 1:1 ratio. One of the subjects' main caregiver should be involved to get the information of function of daily life and help to complete scale evaluation.
The study lasts about 33 weeks, during which eligible patients will be given 1 g/day/dose of ceftriaxone or placebo via injection 3 doses every cycle (2 weekly cycle), for a total of 16 cycles. And the subjects can choose to get injection either in the clinical site or in their house.
- Conditions
- Parkinson's Disease Dementia
- Being tested
- Ceftriaxone, Placebo
- Keywords
- Parkinson's Disease, Parkinson's Disease Dementia
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
Also called Ceftriaxone Sandoz powder for IV Injection
1 g ceftriaxone per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle
PlaceboOther
Placebo per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone | Experimental | 1. Name: Ceftriaxone
2. Dosage form: crystalline powder for intramuscular injection
3. Dose(s): 1 g
4. Dosing schedule: 1 g ceftriaxone with around 2.0 ml of lidocaine solvent per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle Receives: Drug: Ceftriaxone |
| Placebo | Placebo comparator | same amount volume of placebo will be given on Day 1, Day 3, and Day 5 per cycle on a 2 weekly cycle Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the treatment difference in mean net change in ADAS-Cog score with time course
ADAS-Cog is a validated instrument to assess dementia covering memory, orientation, language, praxis and consisting of 11 items. The total possible scores range from 70 (severe impairment) to 0 (no impairment).
Measured: from baseline to week 17 and 33 visits
Secondary outcomes (8)
Changes in Unified Parkinson's Disease Rating Scale (UPDRS) score
The UPDRS system is a composite scale intended for rating patients with PD. Scores are rated as 0-4 (0-1 for some Part IV), representing 0=normal and 1 or 4=maximal deficit, symptoms, or impairment.
Measured: from baseline to week 17 and 33 visits
Changes in Judgment of Line Orientation score
The Judgment of Line Orientation (JLO) test is a widely used measure of visuospatial judgment. A score of 17 or less is considered a sign of severe deficit.
Measured: from baseline to week 17 and 33 visits
Changes in Mini-Mental State Examination (MMSE) score
The MMSE is a brief, quantitative measure of cognitive status in adults. The instrument examines orientation, registration, attention, calculation, recall, visuo-spatial abilities and language. The maximum score is 30, with higher scores indicating better cognitive function.
Measured: from baseline at week 17 and 33 visits
Changes in Clinical Dementia Rating (CDR) Scale score
The CDR Scale is a 5-point scale used to characterize 6 domains of cognitive and functional performance applicable to related dementias: memory, orientation, judgment \& problem solving, community affairs, home \& hobbies, and personal care. This score is useful for characterizing and tracking a patient's level of impairment/dementia with 0=normal, 0.5 =very mild dementia, 1=mild dementia, 2=moderate dementia, 3=severe dementia.
Measured: from baseline to week 17 and 33 visits
Changes in Color Trail Test score
Color Trail Test provides quantitative and qualitative information by two trials. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.
Measured: from baseline to week 17 and 33 visits
Changes in MRI image for atrophy rate of brain
Multimodal MRI examinations will be performed on a 3T MRI scanner with a standard 8-channel head coil. Region of interest in the brain will be evaluated for functional changes including atrophy rate from baseline data.
Measured: from baseline to week 17 and 33 visits
Changes in MRI image for dopaminergic projection from substantia nigra to striatum
Multimodal MRI examinations will be performed on a 3T MRI scanner with a standard 8-channel head coil. Region of interest in the brain will be evaluated for functional changes including dopaminergic projection from baseline data.
Measured: from baseline to week 17 and 33 visits
Changes in Tc-99m TRODAT SPECT image
SPECT assessment will use Tc-99m, a radio tracer with high selectivity and specificity for the striatum dopamine transporter (DAT) density evaluation. DAT density change from baseline will be calculated from region of interest drawn in the striatum by independent readers.
Measured: from baseline to week 17 and 33 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start15 Feb 2019
- Primary completion28 Jul 2025
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease DementiaStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainX Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Joshua Ho, Study director, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413384
- Sponsor's protocol ID
- BRICEFA20170414
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2018
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poewe W, Gauthier S, Aarsland D, Leverenz JB, Barone P, Weintraub D, Tolosa E, Dubois B. Diagnosis and management of Parkinson's disease dementia. Int J Clin Pract. 2008 Oct;62(10):1581-7. doi: 10.1111/j.1742-1241.2008.01869.x.
PubMed 18822028
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia
- ClinicalTrials.gov ID
- NCT03413384
- Acronym / sponsor ID
- BRICEFA20170414
- Conditions
- Parkinson's Disease Dementia
- Keywords
- Parkinson's Disease, Parkinson's Disease Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BrainX CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 29 Jan 2018 (actual)
- 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.
This is a randomized, double blinded, placebo-controlled Phase II study to investigate the efficacy and safety of ceftriaxone in patients with mild to moderate Parkinson's disease dementia (PDD).This study will enroll approximately 106 patients to have up to 84 evaluable subjects, and conduct in Chung Shan Medical University Hospital, National Taiwan University Hospital, Kaohsiung Chang Gung Memorial Hospital, China Medical University Hospital, Changhua Christian Hospital, and Taipei Veterans General Hospital.
Detailed description
Parkinson's disease (PD) is a common neurodegenerative disorder that can cause significant disability and decrease quality of life. It is a chronic and progressive disease which means the symptoms become worse over time.
Parkinson's disease dementia (PDD) is a decline in thinking and reasoning that develops in many people living with PD at least a year after diagnosis. An estimated 50 to 80 percent of patients with PD eventually experience dementia as the disease progresses. Ceftriaxone is a kind of antibiotics, which has been marketed in many countries. This is the first time for ceftraxone treatment on PDD patient. The primary objective of this Phase II study is to evaluate the improvement of cognitive function in PDD patients with ceftriaxone administration.
This study will enroll approximately 106 patients, and conduct in multiple hospitals in Taiwan. Recruitment number of each site will be adjusted according to its enrollment status under the competitive enrollment model. Subjects will receive either ceftriaxone or placebo in a 1:1 ratio. One of the subjects' main caregiver should be involved to get the information of function of daily life and help to complete scale evaluation.
The study lasts about 33 weeks, during which eligible patients will be given 1 g/day/dose of ceftriaxone or placebo via injection 3 doses every cycle (2 weekly cycle), for a total of 16 cycles. And the subjects can choose to get injection either in the clinical site or in their house.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone | Experimental | Drug: Ceftriaxone1. Name: Ceftriaxone 2. Dosage form: crystalline powder for intramuscular injection 3. Dose(s): 1 g 4. Dosing schedule: 1 g ceftriaxone with around 2.0 ml of lidocaine solvent per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle |
| Placebo | Placebo comparator | Other: Placebosame amount volume of placebo will be given on Day 1, Day 3, and Day 5 per cycle on a 2 weekly cycle |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients are male or female, age 50-85 years, inclusive.
- Diagnosis of idiopathic Parkinson's disease (PD) based on the UK Parkinson's Disease Society Brain Bank Criteria and with a modified Hoehn and Yahr Stage of I to IV.
- Patients have been receiving stable dose of medications equivalent up to 1800 mg/day of levodopa for Parkinson's disease at least 2 weeks prior to screening and patients are considered as being optimally treated at screening and no known further adjustments of current medication needed to improve the subject's status of PD during the study period by the judgment of the Investigator based on the subject's history, previous treatments, and the clinical presentation.
- Diagnosis of PDD based on Movement Disorder Society (MDS) Task Force criteria as the following items:
- Patients who are eligible and able to participate in the study must be judged by the investigator to evaluate the competency of providing informed consent for this dementia related study (the decision making is based on MacArthur Competence Assessment concept) and should be able to understand the language in which the tests require so and must be able to perform all the assessments.
Key exclusion criteria (23 listed)
- Any indication of forms of Parkinsonism other than idiopathic PD.
- Diagnosis of possible PDD.
- Diagnosis of dementia with Lewy Bodies.
- Mental/physical/social condition which could preclude performing efficacy or safety assessments.
- Medical history of brain or other clinically significant neurological/psychiatric disorders or injuries other than PD or PDD that would hinder or interfere the study safety or efficacy evaluation in the opinion of the Investigator.
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 |
|---|---|---|
| CeftriaxoneAlso: Ceftriaxone Sandoz powder for IV Injection1 g ceftriaxone per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle | Drug | Ceftriaxone |
| PlaceboPlacebo per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle | Other | Placebo |
Primary outcome
Compare the treatment difference in mean net change in ADAS-Cog score with time course
Time frame: from baseline to week 17 and 33 visits
ADAS-Cog is a validated instrument to assess dementia covering memory, orientation, language, praxis and consisting of 11 items. The total possible scores range from 70 (severe impairment) to 0 (no impairment).
8 secondary outcomes
Changes in Unified Parkinson's Disease Rating Scale (UPDRS) score
Time frame: from baseline to week 17 and 33 visits
Changes in Judgment of Line Orientation score
Time frame: from baseline to week 17 and 33 visits
Changes in Mini-Mental State Examination (MMSE) score
Time frame: from baseline at week 17 and 33 visits
Changes in Clinical Dementia Rating (CDR) Scale score
Time frame: from baseline to week 17 and 33 visits
Changes in Color Trail Test score
Time frame: from baseline to week 17 and 33 visits
Changes in MRI image for atrophy rate of brain
Time frame: from baseline to week 17 and 33 visits
Changes in MRI image for dopaminergic projection from substantia nigra to striatum
Time frame: from baseline to week 17 and 33 visits
Changes in Tc-99m TRODAT SPECT image
Time frame: from baseline to week 17 and 33 visits
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 22 Jul 2026.
- Background: PubMed 18822028Poewe W, Gauthier S, Aarsland D, Leverenz JB, Barone P, Weintraub D, Tolosa E, Dubois B. Diagnosis and management of Parkinson's disease dementia. Int J Clin Pract. 2008 Oct;62(10):1581-7. doi: 10.1111/j.1742-1241.2008.01869.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Ho study director
China Medical University, China
6 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 Ceftriaxone in people with Parkinson's Disease Dementia, run by BrainX Corporation at 6 sites in Taiwan.
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 16 inclusion and 23 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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?
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?
Compare the treatment difference in mean net change in ADAS-Cog score with time course (time frame: from baseline to week 17 and 33 visits). 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 NCT03413384, 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 22 Jul 2026.