Neuropathic PainPhase 2NDMC-201NCT04480164
Evaluation of the Safety and Efficacy of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain
A Phase 2 study testing NDMC in people with Neuropathic Pain, run by Besson Marie at 1 site in Switzerland.
Trial summary
Neuropathic pain (NP) affects up to 8% of the general population and its successful management is an unmet medical need. Half of the patients report inadequate response to therapy and unwanted side effects such as sedation and cognitive impairments, limiting drug use in daily practice and significantly accounting for… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- NDMC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jun 2020to 31 May 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature (Appendix 1: Informed Consent Form);
- Male or female participants (if female: post-menopausal or surgically sterile, or using a highly effective method of contraception);
- Between 18 and 85 years of age;
- Body mass index ≥ 18 and < 40 (kg/m2);
- Patients diagnosed with small fiber neuropathy OR suffering from peripheral neuropathic pain related to diabetic peripheral neuropathy; post-herpetic neuralgia; HIV-associated neuropathic pain; post-traumatic/postoperative peripheral neuropathy; chemotherapy associated peripheral neuropathy or nerve root/medullar compression with sensory/motor deficit OR presenting with neuropathic pain associated with diagnosed rare hereditary or acquired neurological disease; AND who presented insufficient response to at least one attempt with one of the currently recommended pharmacological treatment for neuropathic pain taken at efficacious dose OR who have interrupted treatment because of tolerance issue OR who have previously declined pharmacological pain management;;
- Pain duration for at least 3 months;
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- Preceding week pain recall score ≥ 4 on NRS Scale;
- Score ≥ 4 on DN4 questionnaire;
- Willing to withdraw from prohibited medications;
- Poor-metabolizers (PM) for CYP2C19 are only eligible for Sequence 3
Who cannot join
- Contraindications to benzodiazepines.(including known hypersensitivity reaction)
- Women who are pregnant or breast feeding or who intend on becoming pregnant during the course of the study;
- Woman of childbearing potential, not using and not willing to continue using a highly effective method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;
- Abnormal ASAT or ALAT plasma levels (> 3x ULN);
- Reduced renal function (GFR < 60 mL/min/1.73m2);
- Changes in existing (or addition of new) concomitant interventional pain management (including local anaesthetic infiltration, local nerve block, central neurostimulation therapy) and other non-pharmacological intervention such as desensitization techniques, acupuncture, transcutaneous electrostimulation, hypnosis;
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- Co-existing nociceptive or inflammatory aetiology to the current pain symptoms;
- Unable to withdraw from prohibited medications before randomization;
- Epilepsy;
- History of drug, alcohol or substance abuse in the past 5 years (with the exception of stable opioid substitution therapy in the past 5 years);
- Current unstable psychiatric disorder or any such disorder that may impair patient's abilities to follow study procedures;
- Sleep apnea (unless treated with CPAP with an oxygen desaturation index < 5 per hour), myasthenia gravis, severe respiratory failure;
- Participation in another study with investigational drug within the 3 month preceding and during the present study (a wash-out of period at least 3 months is necessary prior to screening).
- Score < 24 on MMS in patients over 65 years of age
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
About this study
Official title: A Randomized Double-blind Ascending-dose Placebo-controlled Study of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain
Neuropathic pain (NP) affects up to 8% of the general population and its successful management is an unmet medical need. Half of the patients report inadequate response to therapy and unwanted side effects such as sedation and cognitive impairments, limiting drug use in daily practice and significantly accounting for the high incidence of treatment failure. Dysfunction of synaptic inhibition within the spinal cord is known to be one of the main contributing factors to central sensitization that governs NP. Facilitation of GABAergic inhibition in the dorsal horn through GABAA receptors allosteric modulation would be a rational approach to NP management. New insights on the associations between GABAA receptors α subunits and function have opened new perspectives in preclinical research. Data from genetically modified mice demonstrates the possibility, through selective allosteric modulation of the GABAA receptor, to induce its beneficial antihyperalgesic effects without inducing its cognitive and sedative effects. N-Desmethylclobazam (NDMC), clobazam's main active metabolite, demonstrated in vitro and in vivo a high selectivity profile with a clear preference for GABAA α2-subtypes receptors (antihyperalgesia) over α1 receptors responsible for sedative effects across a wide concentration range. Taking into consideration the high prevalence and burden of neuropathic and chronic pain worldwide and the fact that these patients are nowadays left with sedative and only partially effective drugs, NDMC qualifies as a good molecule to seek confirmation of the clinical utility of selective GABAA allosteric modulators in NP patients.The main objective is to assess the efficacy of repeated doses of NDMC on neuropathic pain compared to placebo.
- Conditions
- Neuropathic Pain
- Being tested
- NDMC
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDMCDrug
Also called Placebo
Repeated oral administration of ascending daily doses of NDMC (40mg, 60mg,120mg/day) vs placebo in 3 sequential cohorts
| Study group | Role | What they receive |
|---|---|---|
| NDMC 40 mg/day | Experimental | Oral administration of two NDMC 20mg capsules per day over 6 weeks Receives: Drug: NDMC |
| NDMC 60 mg/day | Experimental | Oral administration of three NDMC 20mg capsules per day over 6 weeks Receives: Drug: NDMC |
| NDMC 120 mg/day | Experimental | Oral administration of six NDMC 20mg capsules per day over 6 weeks Receives: Drug: NDMC |
| Placebo | Placebo comparator | Oral administration respectively, according to the experimental arm considered, of two, three or six placebo capsules per day over 6 weeks Receives: Drug: NDMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Average of daily Pain intensity score (WAP)
Participant will self-rate once every day his average daily pain. The weekly average of daily pain intensity score will be derived from the 7 (at least 5) recordings preceding Baseline (Week 0) and Final evaluation (Week 6). Numerical Rating Scale = 0 "no pain" to 10 = "worst possible pain". The primary outcome will be the change from Baseline to Final evaluation.
Measured: Week 0, Week 6 following first drug administration
Secondary outcomes (15)
Evolution of Weekly Average of daily Pain intensity score (EWAP)
Assessment of the evolution overtime of the weekly average of daily pain intensity score between Baseline (Week 0) and Final evaluation (Week 6).
Measured: Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 following first drug administration
Weekly Average of daily subjective feeling of Sedation (WAS)
Participant will self-rate once every day his daily subjective feeling of sedation. The weekly average of daily subjective feeling of sedation score will be derived from the 7 (at least 5) recordings preceding Baseline (Week 0) and Final Evaluation (Week 6). Numerical Rating Scale = 0 "not sleepy" to 10 = "extremely sleepy".
Measured: Week 0, Week 6 following first drug administration
Evolution of Weekly Average of daily subjective feeling of Sedation (EWAS)
Assessments of the evolution overtime of the weekly average of daily subjective feeling of sedation score, each week between Baseline (Week 0) and Final evaluation (Week 6).
Measured: Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 following first drug administration
Composite 2-Dimension Score (C2-D)
The Composite 2-Dimension score will assess the benefit/tolerance balance of NDMC for each dose. The score is defined as the aggregated value of the changes between baseline and final evaluation on the weekly average of daily pain intensity score and the weekly average of daily subjective sedation score. Score ranges from -10 to + 16. Score ≤ -2 indicates a favorable balance and score ≥ 2 an unfavorable balance.
Measured: Week 0, Week 6 following first drug administration
Evolution of Composite 2-Dimension Score (EC2-D)
Assessments of the evolution overtime of the Composite 2-Dimension score, each week between Baseline (Week 0) and Final evaluation (Week 6).
Measured: Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 following first drug administration
Douleur neuropathique 4 questionnaire (DN4)
Participant will complete the DN4 questionnaire which is a screening tool for neuropathic pain consisting of interview questions. This questionnaire gives a score ranging from 0 (better) to 10 (worse); a score ≥4 is an indicator of plausible neuropathic pain.
Measured: Week 0, Week 2, Week 6 following first drug administration
Neuropathic Pain Symptom Inventory (NPSI)
Participant will complete the NPSI questionnaire which is an inventory tool for neuropathic pain consisting of interview questions.This questionnaire has 12 scaled scores and gives a score ranging from 0 (better) to 100 (worse)
Measured: Week 0, Week 2, Week 6 following first drug administration
Short Form Questionnaire (SF-36)
Participant will complete the health status questionnaire consisting of 36 interview questions. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Measured: Week 0, Week 2, Week 6 following first drug administration
Hospital Anxiety and Depression Scale (HADS)
Participant will complete the anxiety and depression questionnaire consisting in two sets of 7 questions on anxiety or depression. HADS gives anxiety and depression scores both ranging from 0 (better) to 21 (worse)
Measured: Week 0, Week 2, Week 6 following first drug administration
Patient Global Impression of Change (PGIC)
Participant will complete the PGIC questionnaire, which is a 7-point scale ranging from -3 (very much worse), 0 (no change), to +3 (very much improved) answering the question: "Please, indicate how you feel now, compared to how you felt before receiving treatment in this study"
Measured: Visit 1 to Visit 7
Clinician Global Impression of Improvement (CGI-I)
Investigator will complete CGI questionnaire which is a 7-point CGI scale: from 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) to 7 (very much worse) answering the question: "Please, indicate how much the patient's condition has improved or worsened relative to a baseline state at the beginning of the intervention"
Measured: Week 0, Week 2, Week 6 following first drug administration
Medical Outcome Study Sleep Score (MOS-Sleep)
Participant will complete the MOS-sleep questionnaire, which is composed of 12 items. Higher scores reflect more of the attribute implied by the scale names
Measured: Week 0, Week 2, Week 6 following first drug administration
Responder Rates (30% / 50%)
Participants will be dichotomized into "responders" and "non-responders" categories. These transformations will be based on the reduction of at least 30%, respectively 50%, of the weekly average daily pain intensity score between Baseline (Week 0) and Final evaluation (Week 6).
Measured: Week 0, Week 6 following first drug administration
Rescue Medication Rate
Participants will be dichotomized into "rescue med" and "no rescue med" categories. This transformation will be based on the use of rescue medications between Baseline (Week 0) and Final evaluation (Week 6).
Measured: Week 0, Week 6 following first drug administration
Withdrawal Rate
Participants will be dichotomized into "early withdrawal" and "completion" categories. This transformation will be based on the occurrence of premature withdrawal related to lack of efficacy or due treatment emergent adverse effect between Baseline (Week 0) and Final evaluation (Week 6).
Measured: throughout the study (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start24 Jun 2020
- Primary completion1 Sep 2022
- Study completion31 May 2023 (estimated)
Why it stopped: low recruitment rate and end of study finding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Sequential
- Model description
- 3 Sequences separated by 2 interim analyses evaluating safety and PK linearity. Sequence 1: 8 Patients randomized to placebo or NDMC 40mg/day (ratio 1:3) qd for 6 weeks. Sequence 2 will be initiated following the first interim analysis. Sequence 2: 8 Patients randomized to placebo or NDMC 60mg/day (ratio 1:3) qd for 6 weeks. Sequence 3 will be initiated following the second interim analysis. Otherwise Sequence 2 will be extended to a total of 30 placebo and 32 patients. Sequence 3: 60 Patients randomized to placebo or NDMC 60mg/day (ratio 28:32) bid for 6 weeks. Patients who do not tolerate 120mg/day will be authorized to step down to 60mg/day during the up titration period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Besson Marie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Besson Marie, University Hospital, Geneva
- Investigators
- Marie Besson, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480164
- Sponsor's protocol ID
- 2019-01113
- Other IDs
- 2019
- Acronym
- NDMC-201
- Status last verified
- May 2023
- First submitted
- 11 Jun 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Ascending-dose Placebo-controlled Study of N-desmethylclobazam in Patients With Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04480164
- Acronym / sponsor ID
- NDMC-201 / 2019-01113
- Conditions
- Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: low recruitment rate and end of study finding
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Besson MarieUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 21 Jul 2020 (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.
Neuropathic pain (NP) affects up to 8% of the general population and its successful management is an unmet medical need. Half of the patients report inadequate response to therapy and unwanted side effects such as sedation and cognitive impairments, limiting drug use in daily practice and significantly accounting for the high incidence of treatment failure. Dysfunction of synaptic inhibition within the spinal cord is known to be one of the main contributing factors to central sensitization that governs NP. Facilitation of GABAergic inhibition in the dorsal horn through GABAA receptors allosteric modulation would be a rational approach to NP management. New insights on the associations between GABAA receptors α subunits and function have opened new perspectives in preclinical research. Data from genetically modified mice demonstrates the possibility, through selective allosteric modulation of the GABAA receptor, to induce its beneficial antihyperalgesic effects without inducing its cognitive and sedative effects. N-Desmethylclobazam (NDMC), clobazam's main active metabolite, demonstrated in vitro and in vivo a high selectivity profile with a clear preference for GABAA α2-subtypes receptors (antihyperalgesia) over α1 receptors responsible for sedative effects across a wide concentration range. Taking into consideration the high prevalence and burden of neuropathic and chronic pain worldwide and the fact that these patients are nowadays left with sedative and only partially effective drugs, NDMC qualifies as a good molecule to seek confirmation of the clinical utility of selective GABAA allosteric modulators in NP patients.The main objective is to assess the efficacy of repeated doses of NDMC on neuropathic pain compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 3 Sequences separated by 2 interim analyses evaluating safety and PK linearity. Sequence 1: 8 Patients randomized to placebo or NDMC 40mg/day (ratio 1:3) qd for 6 weeks. Sequence 2 will be initiated following the first interim analysis. Sequence 2: 8 Patients randomized to placebo or NDMC 60mg/day (ratio 1:3) qd for 6 weeks. Sequence 3 will be initiated following the second interim analysis. Otherwise Sequence 2 will be extended to a total of 30 placebo and 32 patients. Sequence 3: 60 Patients randomized to placebo or NDMC 60mg/day (ratio 28:32) bid for 6 weeks. Patients who do not tolerate 120mg/day will be authorized to step down to 60mg/day during the up titration period.
| Arm | Type | Receives |
|---|---|---|
| NDMC 40 mg/day | Experimental | Drug: NDMCOral administration of two NDMC 20mg capsules per day over 6 weeks |
| NDMC 60 mg/day | Experimental | Drug: NDMCOral administration of three NDMC 20mg capsules per day over 6 weeks |
| NDMC 120 mg/day | Experimental | Drug: NDMCOral administration of six NDMC 20mg capsules per day over 6 weeks |
| Placebo | Placebo comparator | Drug: NDMCOral administration respectively, according to the experimental arm considered, of two, three or six placebo capsules per day over 6 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed Consent as documented by signature (Appendix 1: Informed Consent Form);
- Male or female participants (if female: post-menopausal or surgically sterile, or using a highly effective method of contraception);
- Between 18 and 85 years of age;
- Body mass index ≥ 18 and < 40 (kg/m2);
- Patients diagnosed with small fiber neuropathy OR suffering from peripheral neuropathic pain related to diabetic peripheral neuropathy; post-herpetic neuralgia; HIV-associated neuropathic pain; post-traumatic/postoperative peripheral neuropathy; chemotherapy associated peripheral neuropathy or nerve root/medullar compression with sensory/motor deficit OR presenting with neuropathic pain associated with diagnosed rare hereditary or acquired neurological disease; AND who presented insufficient response to at least one attempt with one of the currently recommended pharmacological treatment for neuropathic pain taken at efficacious dose OR who have interrupted treatment because of tolerance issue OR who have previously declined pharmacological pain management;;
Key exclusion criteria (14 listed)
- Contraindications to benzodiazepines.(including known hypersensitivity reaction)
- Women who are pregnant or breast feeding or who intend on becoming pregnant during the course of the study;
- Woman of childbearing potential, not using and not willing to continue using a highly effective method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;
- Abnormal ASAT or ALAT plasma levels (> 3x ULN);
- Reduced renal function (GFR < 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 |
|---|---|---|
| NDMCAlso: PlaceboRepeated oral administration of ascending daily doses of NDMC (40mg, 60mg,120mg/day) vs placebo in 3 sequential cohorts | Drug | NDMC 120 mg/day, NDMC 40 mg/day, NDMC 60 mg/day, Placebo |
Primary outcome
Weekly Average of daily Pain intensity score (WAP)
Time frame: Week 0, Week 6 following first drug administration
Participant will self-rate once every day his average daily pain. The weekly average of daily pain intensity score will be derived from the 7 (at least 5) recordings preceding Baseline (Week 0) and Final evaluation (Week 6). Numerical Rating Scale = 0 "no pain" to 10 = "worst possible pain". The primary outcome will be the change from Baseline to Final evaluation.
15 secondary outcomes
Evolution of Weekly Average of daily Pain intensity score (EWAP)
Time frame: Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 following first drug administration
Weekly Average of daily subjective feeling of Sedation (WAS)
Time frame: Week 0, Week 6 following first drug administration
Evolution of Weekly Average of daily subjective feeling of Sedation (EWAS)
Time frame: Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 following first drug administration
Composite 2-Dimension Score (C2-D)
Time frame: Week 0, Week 6 following first drug administration
Evolution of Composite 2-Dimension Score (EC2-D)
Time frame: Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 following first drug administration
Douleur neuropathique 4 questionnaire (DN4)
Time frame: Week 0, Week 2, Week 6 following first drug administration
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Week 0, Week 2, Week 6 following first drug administration
Short Form Questionnaire (SF-36)
Time frame: Week 0, Week 2, Week 6 following first drug administration
Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 0, Week 2, Week 6 following first drug administration
Patient Global Impression of Change (PGIC)
Time frame: Visit 1 to Visit 7
Clinician Global Impression of Improvement (CGI-I)
Time frame: Week 0, Week 2, Week 6 following first drug administration
Medical Outcome Study Sleep Score (MOS-Sleep)
Time frame: Week 0, Week 2, Week 6 following first drug administration
Responder Rates (30% / 50%)
Time frame: Week 0, Week 6 following first drug administration
Rescue Medication Rate
Time frame: Week 0, Week 6 following first drug administration
Withdrawal Rate
Time frame: throughout the study (up to 6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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.
Marie Besson, MD principal investigator
University Hospital, Geneva
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 NDMC in people with Neuropathic Pain, run by Besson Marie at 1 site in Switzerland.
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 10 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: paused, as of the sponsor's last update on 10 May 2023. 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 Switzerland. 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?
Results are not available in the source record.
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?
Weekly Average of daily Pain intensity score (WAP) (time frame: Week 0, Week 6 following first drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2023.