Diabetic NeuropathyPhase 2NCT01822925
Study of DA-9801 to Treat Diabetic Neuropathy
A Phase 2 study testing DA-9801 300mg, DA-9801 600mg and DA-9801 900mg in people with Diabetic Neuropathy, run by NeuroBo Pharmaceuticals Inc. at 14 sites in United States.
Trial summary
To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain in subjects with diabetic neuropathic pain compared to their baseline values. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- DA-9801 300mg, DA-9801 600mg and DA-9801 900mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 14 sitesUnited States
- Study dates
- Nov 2013to Jan 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 to 75 years of age
- Diagnosed with Type I or Type II diabetes
- HbA1c ≤ 12% at the time of screening
- Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the lower extremities for more than 3 months prior to screening and with no adequate relief from other treatments
- Has an average pain score of ≥ 4 for 24 hours at least 4 days out of the week prior to randomization as assessed by the 11-point Likert NRS.
- If female of childbearing potential, subject must have a negative serum pregnancy test at screening
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- Understands and is willing to participate in the clinical study and can comply with study procedures and visits.
- Normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-reported questionnaires
- Subject is willing and able to give informed consent
Who cannot join
- Evidence of another type of neuropathic pain caused by a condition other than diabetes
- Pain from another source as severe or greater than the pain under study
- BMI (Body Mass Index) > 37 kg/m2
- Clinical signs of infection related to sores of any type on the legs
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or subject or physician anticipates use of any of these therapies by the subject during the course of the study
- Previous participation in the Treatment Phase of this Protocol
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- History of drug or alcohol abuse, within the past 6 months
- Malignant disease not in remission for 5 years or more that has been medically or surgically treated without evidence of metastases
- Presence of one or more medical conditions, as determined by medical history, which seriously compromises the subject's ability to complete the study, including history of poor adherence with medical treatment, renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study: c) One or more abnormal blood biochemistry analyte result that is ≥ 3 times that of the upper limit of the normal range; d) For laboratory results that are significantly lower than the normal range, specific criteria will be used to judge subject eligibility for randomization for Total protein, Albumin, and Hemoglobin or Platelets.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV)
- New York Heart Association (NYHA) Class III and IV congestive heart failure (CHF), as defined by the following criteria: a)Class III: Symptoms with moderate exertion b)Class IV: Symptoms at rest
- Pregnant or breast feeding
- Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:
- Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/m, OR; e) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, OR; f) Are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation.
- Subjects with a diagnosis of psychiatric disorders such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or suicidality/suicide ideation
- Administration of local anesthetic shot or systemic steroids within two months of screening
- Subjects not willing to undergo a two-week washout period for pharmacologic and non-pharmacologic pain management techniques
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Albany Medical Center
Albany, New York, 12208
Johns Hopkins University
Baltimore, Maryland, 21205
PAB Clinical Research
Brandon, Florida, 33511
KRK Research
Dallas, Texas, 75230
North Texas Endocrine Center
Dallas, Texas, 75231
Houston Foot & Ankle Care
Houston, Texas, 77074
Center for United Research, Inc.
Lakewood, California, 90712
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Novex Clinical Research, Inc.
New Bedford, Massachusetts, 02740
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Diablo Clinical Research
Walnut Creek, California, 94598-3347
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
About this study
Official title: A Phase II Randomized, Double-Blind, Parallel Group, Dose-Ranging, Placebo-Controlled Study to Assess the Safety And Effectiveness Of DA-9801 in the Treatment of Subjects With Diabetic Neuropathy
To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain in subjects with diabetic neuropathic pain compared to their baseline values.
Read the detailed description
This is a double-blind, randomized, parallel group, dose ranging, placebo-controlled study where eligible subjects (age 18 to 75 years) will have an average pain score ≥ 4 on an 11-point Likert numerical rating scale (NRS) for at least four days each week prior to randomization as assessed by daily pain diaries. Eligible subjects will be randomized to a 1:1:1:1 ratio to receive 300mg, 600mg, 900mg of DA-9801, or placebo three times a day for 12 weeks. During and at the end of the 12-week treatment period subjects will be evaluated for safety and efficacy parameters. A follow-up visit for safety will occur two weeks after the last treatment visit (TV).
The Screening Phase (2 weeks) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility. Eligible subjects will undergo a two-week washout period for medications and therapies administered for pain management.
At or up to 21 days before the Screening Visit, written informed consent from (ICF) the subject will be obtained by the Investigator or a suitably qualified designee before the performance of any protocol specific procedure. At the Screening Visit, the subject will be issued a daily diary in order to record daily pain level during the screening phase.
The Treatment Phase (TV0 to TV12) begins with a series of assessments designed to confirm the subjects' continued eligibility. The site will collect the daily diary and the subject's pain score will be determined. Only subjects whose average pain score is ≥ 4 for at least four days each week will be randomized to any of the four treatment groups.
DA-9801 administration schedule is three times per day, starting from TV0 to TV12.
During this study phase subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include the subject's global impression of improvement and CGI of pain. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit.
The Follow-up Visit (two weeks after last TV) The Follow-up Visit is designed to assess safety and will occur 14 days after the last TV. If the subject is withdrawn from the study prior to TV12, the subject should be exited from the study AFTER completing the specified assessments for that visit.
- Conditions
- Diabetic Neuropathy
- Being tested
- DA-9801 300mg, DA-9801 600mg, DA-9801 900mg, Placebo
- Keywords
- Diabetes, Pain, Neuropathy
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-9801 300mgDrug
300 mg of DA-9801 in tablet form, 100 mg to be taken 3 times daily for 12 weeks.
DA-9801 600mgDrug
600 mg of DA-9801 in tablet form, 200 mg to be taken 3 times daily for 12 weeks.
DA-9801 900mgDrug
900 mg of DA-9801 in tablet form, to be taken 300 mg to be taken 3 times daily for 12 weeks.
PlaceboDrug
Placebo, in tablet form, to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient.
| Study group | Role | What they receive |
|---|---|---|
| DA-9801 300mg | Experimental | DA-9801 will be administered in tablet form, 100mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. Receives: Drug: DA-9801 300mg |
| DA-9801 600mg | Experimental | DA-9801 will be administered in tablet form, 200 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. Receives: Drug: DA-9801 600mg |
| DA-9801 900mg | Experimental | DA-9801 will be administered in tablet form, 300 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. Receives: Drug: DA-9801 900mg |
| Placebo | Placebo comparator | Placebo (same formulation as DA-9801 but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)
Pain score was assessed by the subject using the 11-point Likert rating scale for pain (0=no pain to 10=worst possible pain) prior to conduct of any other study assessment. The change in clinic visit pain score at the 12-week visit was compared to baseline.
Measured: Baseline to 12 weeks of treatment
Secondary outcomes (10)
Percentage Change in Clinic Visit Pain Score at the 12-week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)
Pain intensity was assessed by the subject before any other protocol procedures at baseline and at the 12- week visit using an 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain) (Negative values indicate percentage reductions).
Measured: Baseline and over 12 week treatment period
Number of Participants With at Least 30% Improvement Compared to Baseline as Assessed by the 11- Point Likert Numerical Rating Scale (NRS) at the Week 12 Clinic Visit
Pain intensity was assessed by the subject before any other protocol procedures at baseline and week 12 based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain).
The number of participants who had achieved ≥ a 30% reduction in pain from the baseline was to be compared between the treatment groups and placebo.
Measured: Baseline to 12 week treatment period
Difference in Average Weekly Pain Score Between Dose Groups as Assessed by Daily Diary
Average 24-hour pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum pain score for a week would be 0 and the maximum would be 70.
Difference in the average weekly pain score at Week 12 is the score for each week minus the baseline .
Measured: Baseline to 12 week treatment period
Difference in Average Weekly Most Severe Pain Score Between Dose Groups as Assessed by Daily Diary
Most severe 24-hour pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly most severe pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70.
Difference in the average weekly pain score at Week 12 is the score at each week minus baseline .
Measured: Baseline to 12 week treatment period
Difference in Average Weekly Overnight Pain Score Between Dose Groups as Assessed by Daily Diary
Overnight pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly overnight pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70.
Difference in the average weekly overnight pain score at Week 12 is the score at each week minus baseline
Measured: Baseline to 12 week treatment period
Change From Baseline Within Group- Difference in Average Weekly Pain Score Compared to Baseline as Assessed by Daily Diary
Average weekly pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70.
Difference in the average weekly pain score at Week 12 is the score at each week minus baseline.
Measured: Baseline to 12 week treatment period
Change From Baseline Within Group-Difference in Average Weekly Overnight Pain Score Compared to Baseline as Assessed by Daily Diary
Overnight pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly overnight pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70.
Difference in the average weekly overnight pain score at Week 12 is the score at each week minus baseline
Measured: Baseline to 12 week treatment period
Number of Participants Considered to be Responders on Global Impression of Improvement (PGI-I) at Week 12
PGI measures the subject's overall improvement in pain. The assessment was to be completed each week during the Treatment Phase.
Global impression of improvement was assessed by the subject based on a 7 point scale (1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, 7-very much worse.
Responders are defined as subjects with response of "very much improved", "much improved" or "minimally improved"
Measured: Week 12
Number of Participants Number of Participants Considered to be Responders in Clinical Global Impression (CGI) at Week 12
CGI measures global severity of illness at a given point of time and the improvement from baseline. The assessment was to be completed by the Investigator at baseline and each week during the treatment phase.
CGI responders were defined as subjects achieving a score of: (1): Very much improved or (2): Much improved or (3): Minimally improved on the clinician-rated CGI global improvement item.
Measured: Week 12
Average Weekly Rescue Medication Use
During the Treatment Periods, subjects taking 500 mg acetaminophen or Tylenol® for severe pain recorded the frequency and dosage in the daily diary. The use of 500 mg acetaminophen or Tylenol® was recorded for Morning, Afternoon or Evening time. For each subject, the total weekly rescue medication was calculated, and it was used to assess average weekly rescue medication use.
Measured: Week 1 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2015
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.
- Other trials for Diabetic 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gabriel Maislos, D.P.M, Principal investigator, Houston Foot & Ankle Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822925
- Sponsor's protocol ID
- DA9801-DN-001
- Status last verified
- Mar 2020
- First submitted
- 21 Mar 2013
- Last updated
- 20 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Parallel Group, Dose-Ranging, Placebo-Controlled Study to Assess the Safety And Effectiveness Of DA-9801 in the Treatment of Subjects With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT01822925
- Acronym / sponsor ID
- DA9801-DN-001
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetes, Pain, Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 20 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain in subjects with diabetic neuropathic pain compared to their baseline values.
Detailed description
This is a double-blind, randomized, parallel group, dose ranging, placebo-controlled study where eligible subjects (age 18 to 75 years) will have an average pain score ≥ 4 on an 11-point Likert numerical rating scale (NRS) for at least four days each week prior to randomization as assessed by daily pain diaries. Eligible subjects will be randomized to a 1:1:1:1 ratio to receive 300mg, 600mg, 900mg of DA-9801, or placebo three times a day for 12 weeks. During and at the end of the 12-week treatment period subjects will be evaluated for safety and efficacy parameters. A follow-up visit for safety will occur two weeks after the last treatment visit (TV).
The Screening Phase (2 weeks) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility. Eligible subjects will undergo a two-week washout period for medications and therapies administered for pain management.
At or up to 21 days before the Screening Visit, written informed consent from (ICF) the subject will be obtained by the Investigator or a suitably qualified designee before the performance of any protocol specific procedure. At the Screening Visit, the subject will be issued a daily diary in order to record daily pain level during the screening phase.
The Treatment Phase (TV0 to TV12) begins with a series of assessments designed to confirm the subjects' continued eligibility. The site will collect the daily diary and the subject's pain score will be determined. Only subjects whose average pain score is ≥ 4 for at least four days each week will be randomized to any of the four treatment groups.
DA-9801 administration schedule is three times per day, starting from TV0 to TV12.
During this study phase subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include the subject's global impression of improvement and CGI of pain. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit.
The Follow-up Visit (two weeks after last TV) The Follow-up Visit is designed to assess safety and will occur 14 days after the last TV. If the subject is withdrawn from the study prior to TV12, the subject should be exited from the study AFTER completing the specified assessments for that visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DA-9801 300mg | Experimental | Drug: DA-9801 300mgDA-9801 will be administered in tablet form, 100mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| DA-9801 600mg | Experimental | Drug: DA-9801 600mgDA-9801 will be administered in tablet form, 200 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| DA-9801 900mg | Experimental | Drug: DA-9801 900mgDA-9801 will be administered in tablet form, 300 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (same formulation as DA-9801 but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be 18 to 75 years of age
- Diagnosed with Type I or Type II diabetes
- HbA1c ≤ 12% at the time of screening
- Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the lower extremities for more than 3 months prior to screening and with no adequate relief from other treatments
- Has an average pain score of ≥ 4 for 24 hours at least 4 days out of the week prior to randomization as assessed by the 11-point Likert NRS.
Key exclusion criteria (17 listed)
- Evidence of another type of neuropathic pain caused by a condition other than diabetes
- Pain from another source as severe or greater than the pain under study
- BMI (Body Mass Index) > 37 kg/m2
- Clinical signs of infection related to sores of any type on the legs
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or subject or physician anticipates use of any of these therapies by the subject during the course of the study
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 |
|---|---|---|
| DA-9801 300mg300 mg of DA-9801 in tablet form, 100 mg to be taken 3 times daily for 12 weeks. | Drug | DA-9801 300mg |
| DA-9801 600mg600 mg of DA-9801 in tablet form, 200 mg to be taken 3 times daily for 12 weeks. | Drug | DA-9801 600mg |
| DA-9801 900mg900 mg of DA-9801 in tablet form, to be taken 300 mg to be taken 3 times daily for 12 weeks. | Drug | DA-9801 900mg |
| PlaceboPlacebo, in tablet form, to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient. | Drug | Placebo |
Primary outcome
Change in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)
Time frame: Baseline to 12 weeks of treatment
Pain score was assessed by the subject using the 11-point Likert rating scale for pain (0=no pain to 10=worst possible pain) prior to conduct of any other study assessment. The change in clinic visit pain score at the 12-week visit was compared to baseline.
10 secondary outcomes
Percentage Change in Clinic Visit Pain Score at the 12-week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)
Time frame: Baseline and over 12 week treatment period
Number of Participants With at Least 30% Improvement Compared to Baseline as Assessed by the 11- Point Likert Numerical Rating Scale (NRS) at the Week 12 Clinic Visit
Time frame: Baseline to 12 week treatment period
Difference in Average Weekly Pain Score Between Dose Groups as Assessed by Daily Diary
Time frame: Baseline to 12 week treatment period
Difference in Average Weekly Most Severe Pain Score Between Dose Groups as Assessed by Daily Diary
Time frame: Baseline to 12 week treatment period
Difference in Average Weekly Overnight Pain Score Between Dose Groups as Assessed by Daily Diary
Time frame: Baseline to 12 week treatment period
Change From Baseline Within Group- Difference in Average Weekly Pain Score Compared to Baseline as Assessed by Daily Diary
Time frame: Baseline to 12 week treatment period
Change From Baseline Within Group-Difference in Average Weekly Overnight Pain Score Compared to Baseline as Assessed by Daily Diary
Time frame: Baseline to 12 week treatment period
Number of Participants Considered to be Responders on Global Impression of Improvement (PGI-I) at Week 12
Time frame: Week 12
Number of Participants Number of Participants Considered to be Responders in Clinical Global Impression (CGI) at Week 12
Time frame: Week 12
Average Weekly Rescue Medication Use
Time frame: Week 1 to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gabriel Maislos, D.P.M principal investigator
Houston Foot & Ankle Care
14 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 DA-9801 300mg, DA-9801 600mg and DA-9801 900mg in people with Diabetic Neuropathy, run by NeuroBo Pharmaceuticals Inc. at 14 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 9 inclusion and 17 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 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 20 Mar 2020). 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 in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS) (time frame: Baseline to 12 weeks of treatment). 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 20 Mar 2020.