Diabetic Peripheral NeuropathyPhase 2RELIEF-DPN 1NCT04455633
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
A Phase 2 study testing LX9211 in people with Diabetic Peripheral Neuropathy and Diabetes, run by Lexicon Pharmaceuticals at 44 sites in United States.
Trial summary
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetes
- What is being tested?
- LX9211
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 44 sitesUnited States
- Study dates
- 3 Sep 2020to 28 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has given written informed consent to participate in the study in accordance with local regulations
- Adult male and female participants ≥18 years of age at the time of screening
- Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
- Diagnosis of diabetic peripheral neuropathic pain (DPNP) at Screening
- Pain from DPN present for at least 6 months
- Haemoglobin A1C ≤11% at screening
- Stable regimen for the treatment of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 month prior to Screening
Who cannot join
- Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- History of major depressive episode, active, significant psychiatric disorders
- History of clinically significant drug or alcohol use disorder
- History of neurolytic or neurosurgical therapy for DPNP
- Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to the Screening Visit
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Lexicon Investigational Site
Anaheim, California, 92801
Lexicon Investigational Site
Ann Arbor, Michigan, 48109
Lexicon Investigational Site
Asheville, North Carolina, 28803
Lexicon Investigational Site
Austin, Texas, 78731
Lexicon Investigational Site
Austin, Texas, 78749
Lexicon Investigational Site
Berlin, New Jersey, 08009
Lexicon Investigational Site
Boston, Massachusetts, 02115
Lexicon Investigational Site
Brandon, Florida, 33511
Lexicon Investigational Site
Cary, North Carolina, 27518
Lexicon Investigational Site
Chandler, Arizona, 85286
Lexicon Investigational Site
Dallas, Texas, 75231
Lexicon Investigational Site
Dearborn, Michigan, 48124
Lexicon Investigational Site
Evansville, Indiana, 47714
Lexicon Investigational Site
Farmington Hills, Michigan, 48334
Lexicon Investigational Site
Flower Mound, Texas, 75028
Lexicon Investigational Site
Fort Myers, Florida, 33912
Lexicon Investigational Site
Glendale, Arizona, 85308
Lexicon Investigational Site
Greenbrae, California, 94904
Lexicon Investigational Site
Greenville, South Carolina, 29607
Lexicon Investigational Site
Hazelwood, Missouri, 63042
Lexicon Investigational Site
Houston, Texas, 77030
Lexicon Investigational Site
Houston, Texas, 77074
Lexicon Investigational Site
Jacksonville, Florida, 32204
Lexicon Investigational Site
Kingman, Arizona, 86409
Lexicon Investigational Site
Lake City, Florida, 32055
Lexicon Investigational Site
Los Angeles, California, 90026
Lexicon Investigational Site
Macon, Georgia, 31210
Lexicon Investigational Site
Mobile, Alabama, 36608
Lexicon Investigational Site
Morehead City, North Carolina, 28557
Lexicon Investigational Site
New Port Richey, Florida, 34652
Lexicon Investigational Site
North Hollywood, California, 91606
Lexicon Investigational Site
Omaha, Nebraska, 68130
Lexicon Investigational Site
Ormond Beach, Florida, 32174
Lexicon Investigational Site
Pearland, Texas, 77584
Lexicon Investigational Site
Renton, Washington, 98057
Lexicon Investigational Site
Sacramento, California, 95821
Lexicon Investigational Site
Salt Lake City, Utah, 84107
Lexicon Investigational Site
South Dartmouth, Massachusetts, 02747
Lexicon Investigational Site
Sterling Heights, Michigan, 48312
Lexicon Investigational Site
Tucson, Arizona, 85741
Lexicon Investigational Site
Tustin, California, 92780
Lexicon Investigational Site
Westfield, New York, 14787
Lexicon Investigational Site
Williamsville, New York, 14221
Lexicon Investigational Site
Winter Park, Florida, 32789
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes
- Being tested
- LX9211, LX9211 Matching Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX9211Drug
Oral Tablets
LX9211 Matching PlaceboDrug
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up. Receives: Drug: LX9211 Matching Placebo |
| LX9211 100 mg/10 mg | Experimental | Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 milligrams (mg), tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up. Receives: Drug: LX9211 |
| LX9211 200 mg/20 mg | Experimental | Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up. Receives: Drug: LX9211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
Measured: Baseline (Week 2 of the Run-in period) to Week 6
Secondary outcomes (7)
Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-30) then participant was considered a Responder and if missing % change from Baseline or >(-30) participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥30% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.
Measured: Baseline (Week 2 of the Run-in period) to Week 6
Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-50) then participant is considered a Responder and if missing % change from Baseline or >(-50) then participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥50% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.
Measured: Baseline (Week 2 of the Run-in period) to Week 6
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
BPI-DPN: questionnaire that assesses severity of pain \& its impact on functioning in participants with DPN. It consists of 4 questions that measure pain at its "worst,"least","average","now"(current pain) on 11-point numerical scale 0=no pain;10=worst pain.Score range:0-10 for each of these pain questions, higher scores=greater pain severity. Other 7 questions of BPI evaluate level of interference of pain on daily functioning (general activity,walking,work ability,mood,enjoyment of life,relations,sleep) on 11-point numerical scale, 0=does not interfere;10=completely interferes.Score range:0-10 for each of these intensity questions, higher scores=greater interference. Pain severity \& pain interference factors are reported as separate categories. Average interference score= mean of 7 interference categories collected in Questions 9A-G, only if 50% (ie at least 4 of 7) of scores were non-missing. Negative change from baseline=improvement. Score range for average interference score: 0-70.
Measured: Baseline (Week 2 of the Run-in period) to Week 6
Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy
Lack of efficacy was defined as an increase of 30% from baseline in ADPS based on question 5 of the BPI-DPN. Baseline was defined as the average of the Week 2 Run-in period data collected by participants in the daily pain diary of BPI-DPN. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where 0 = No Pain to 10 = pain as bad as you can imagine, higher score indicates higher pain intensity.
Measured: Baseline (Week 2 of the Run-in period) to Week 6
Patient Global Impression of Change (PGIC) Scale Score at Week 6
PGIC is a 7-point rating scale that assesses participant's belief about the overall improvement experienced after the end of treatment, where 1= very much improved to 7 = very much worse. Higher score indicates worsening.
Measured: Baseline (Week 2 of the Run-in period) to Week 6
Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6
For participants who achieved ≥30% reduction in ADPS based on Question 5 of the BPI-DPN at Week 6, the time to loss of efficacy was defined as the time from the date of Week 6 visit to the date of termination of safety follow-up due to lack of efficacy. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
Measured: Weeks 6 to 11
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Adverse Events (AE) is defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs that occur or worsen after the first dose of study medication.
Measured: First dose of study drug after randomization up to the end of study (up to Week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start3 Sep 2020
- Primary completion23 May 2022
- Study completion28 Jun 2022
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 Diabetic Peripheral NeuropathyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suma Gopinathan, PhD, Study director, Lexicon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455633
- Sponsor's protocol ID
- LX9211.1-201-DPN
- Other IDs
- LX9211.201
- Acronym
- RELIEF-DPN 1
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2020
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Luo G, Chen L, Kostich WA, Hamman B, Allen J, Easton A, Bourin C, Gulianello M, Lippy J, Nara S, Maishal TK, Thiyagarajan K, Jalagam P, Pattipati SN, Dandapani K, Dokania M, Vattikundala P, Sharma V, Elavazhagan S, Verma MK, Das ML, Wagh S, Balakrishnan A, Johnson BM, Santone KS, Thalody G, Denton R, Saminathan H, Holenarsipur VK, Kumar A, Rao A, Putlur SP, Sarvasiddhi SK, Shankar G, Louis JV, Ramarao M, Conway CM, Li YW, Pieschl R, Tian Y, Hong Y, Ditta J, Mathur A, Li J, Smith D, Pawluczyk J, Sun D, Yip S, Wu DR, Vetrichelvan M, Gupta A, Wilson A, Gopinathan S, Wason S, Bristow L, Albright CF, Bronson JJ, Macor JE, Dzierba CD. Discovery of (S)-1-((2',6-Bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine (BMS-986176/LX-9211): A Highly Selective, CNS Penetrable, and Orally Active Adaptor Protein-2 Associated Kinase 1 Inhibitor in Clinical Trials for the Treatment of Neuropathic Pain. J Med Chem. 2022 Mar 24;65(6):4457-4480. doi: 10.1021/acs.jmedchem.1c02131. Epub 2022 Mar 8.
PubMed 35257579
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04455633
- Acronym / sponsor ID
- RELIEF-DPN 1 / LX9211.1-201-DPN
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Posted 25 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: LX9211 Matching PlaceboFollowing a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up. |
| LX9211 100 mg/10 mg | Experimental | Drug: LX9211Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 milligrams (mg), tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up. |
| LX9211 200 mg/20 mg | Experimental | Drug: LX9211Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant has given written informed consent to participate in the study in accordance with local regulations
- Adult male and female participants ≥18 years of age at the time of screening
- Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
- Diagnosis of diabetic peripheral neuropathic pain (DPNP) at Screening
- Pain from DPN present for at least 6 months
Key exclusion criteria (6 listed)
- Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- History of major depressive episode, active, significant psychiatric disorders
- History of clinically significant drug or alcohol use disorder
- History of neurolytic or neurosurgical therapy for DPNP
- Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
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 |
|---|---|---|
| LX9211Oral Tablets | Drug | LX9211 100 mg/10 mg, LX9211 200 mg/20 mg |
| LX9211 Matching PlaceboOral Tablets | Drug | Placebo |
Primary outcome
Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
7 secondary outcomes
Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Patient Global Impression of Change (PGIC) Scale Score at Week 6
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6
Time frame: Weeks 6 to 11
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose of study drug after randomization up to the end of study (up to Week 11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35257579Luo G, Chen L, Kostich WA, Hamman B, Allen J, Easton A, Bourin C, Gulianello M, Lippy J, Nara S, Maishal TK, Thiyagarajan K, Jalagam P, Pattipati SN, Dandapani K, Dokania M, Vattikundala P, Sharma V, Elavazhagan S, Verma MK, Das ML, Wagh S, Balakrishnan A, Johnson BM, Santone KS, Thalody G, Denton R, Saminathan H, Holenarsipur VK, Kumar A, Rao A, Putlur SP, Sarvasiddhi SK, Shankar G, Louis JV, Ramarao M, Conway CM, Li YW, Pieschl R, Tian Y, Hong Y, Ditta J, Mathur A, Li J, Smith D, Pawluczyk J, Sun D, Yip S, Wu DR, Vetrichelvan M, Gupta A, Wilson A, Gopinathan S, Wason S, Bristow L, Albright CF, Bronson JJ, Macor JE, Dzierba CD. Discovery of (S)-1-((2',6-Bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine (BMS-986176/LX-9211): A Highly Selective, CNS Penetrable, and Orally Active Adaptor Protein-2 Associated Kinase 1 Inhibitor in Clinical Trials for the Treatment of Neuropathic Pain. J Med Chem. 2022 Mar 24;65(6):4457-4480. doi: 10.1021/acs.jmedchem.1c02131. Epub 2022 Mar 8.
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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.
Suma Gopinathan, PhD study director
Lexicon Pharmaceuticals
44 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 LX9211 in people with Diabetic Peripheral Neuropathy and Diabetes, run by Lexicon Pharmaceuticals at 44 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 7 inclusion and 6 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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 25 Jun 2025). 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?
Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale (time frame: Baseline (Week 2 of the Run-in period) to Week 6). 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 NCT04455633, 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 25 Jun 2025.