Chronic Scar PainPhase 2PMOD03NCT03663101
Dysport in Post-Surgical Neuralgia
A Phase 2 study testing Lidocaine and Botulinum toxin type A in people with Chronic Scar Pain, run by Ipsen at 1 site in United Kingdom.
Trial summary
The study is designed to determine whether a currently licensed version of botulinum toxin (Dysport®) is effective for the treatment of pain that has developed and/or persisted for months or years around the scar of a previous surgical site, and whether this condition could be suitable for the testing of similar new… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Scar Pain
- What is being tested?
- Lidocaine and Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2018to 8 Nov 2019
- 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
- Male and female subjects aged between 18 and 75 years inclusive at the time of giving informed consent.
- Subjects suffering from an area of chronic pain post-abdominal or thoracic surgery, chronic abdominal or thoracic scar pain.
- Longitudinal axis of the pain area of 10 cm long maximum (as mapped upon screening).
- Subjects with moderate to severe pain, i.e. spontaneous NRS score of 4-8 which has been stable for the previous month before screening.
- Stable use of analgesics (or any medication impacting pain perception) during the month before screening and expected to be stable for the study duration.
- Under stable medication regimen for other medication, i.e. during the month before screening.
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- Time from surgery which caused the painful scar more than six months and less than ten years at screening.
- No other distracting pain either chronic or acute.
- Female subjects of childbearing potential must have a negative urine pregnancy test result and be willing to use reliable contraceptive measures throughout study participation.
- The subject's primary care physician has provided evidence which can be used to confirm that within the last 12 months of dosing that there is nothing in their medical history that would preclude their enrolment into a clinical study.
Who cannot join
- Previous treatment with Botulinum neurotoxin (BTX) (any serotype) during the past six months before screening.
- History of hypersensitivity to any of the components of the Dysport formulation (which includes human serum albumin and lactose) or allergy to cow's milk protein.
- Known hypersensitivity to lidocaine or other anaesthetics of the amide type, known hypersensitivity to hydroxybenzoates, complete heart block, hypovolaemia.
- Any medical condition that may put the subject at risk with exposure to BTX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
- Opioid analgesic use at a Morphine Equivalent Dosage (MED) of >75mg per day.
- Neuroma in the scar pain area, diagnosed per ultrasound.
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- Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine.
- Need of any prohibited medication.
- Any abnormal laboratory value, physical examination, vital signs, or electrocardiogram (ECG) that, in the opinion of the investigator, is clinically significant and that would compromise the safety of the subject in the study.
- Positive for hepatitis B antigen or hepatitis C virus ribonucleic acid, positive results for human immunodeficiency virus, or who receives diagnosis for acquired immunodeficiency syndrome.
- Positive urine screen for drugs of abuse (except for cotinine and unless explained by the investigator for therapeutic use of medication) or any history of drug or alcohol abuse, misuse, physical or psychological dependence, mood changes, sleep disturbance and functional capacity which have an impact on pain perception.
- Significant neurological or psychiatric disorders including mental instability (unrelated to the pain) that could interfere with pain assessments; other pre-existing pain syndromes, acute or chronic, that might impair the assessment of the scar pain.
- Any medical history of significance and/or inadequately controlled such as cardiovascular (e.g. uncontrolled high blood pressure, high risk of cardiovascular events, severe heart failure), pulmonary (e.g. uncontrolled asthma or emphysema), haematologic, (e.g. coagulopathy/bleeding disorders), neurological (e.g. swallowing problems, blurred or double vision, trouble saying words clearly (dysarthria), hoarseness or change or loss of voice (dysphonia)), liver disease (e.g. severe hepatic impairment), kidney disease (e.g. impaired renal function in subjects taking diuretics, angiotensin converting enzyme (ACE)-inhibitors, or angiotensin II antagonists), endocrine, immunologic, dermatologic painful conditions or any other conditions that may compromise in the opinion of the investigator the ability of the subject to participate in the study.
- Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo Controlled, Proof-of-concept Study in Subjects With Abdominal or Thoracic Chronic Scar Pain to Assess the Analgesic Properties of Intradermal Doses of Dysport®
The study is designed to determine whether a currently licensed version of botulinum toxin (Dysport®) is effective for the treatment of pain that has developed and/or persisted for months or years around the scar of a previous surgical site, and whether this condition could be suitable for the testing of similar new medicines. The study will compare three different doses of Dysport® to see if there is benefit and/or a best dose for treating persistent post-surgery scar pain.
- Conditions
- Chronic Scar Pain
- Being tested
- Lidocaine, Botulinum toxin type A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
0.5 mL (2.5 mg) of lidocaine per injection point will be injected subcutaneously (maximum 10 injection points).
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
0.2 mL of one of three different doses of Dysport per injection point will be injected intradermally (maximum 10 injection points).
PlaceboDrug
Also called Saline solution
Part A - 0.5 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected subcutaneously (maximum 10 injection points).
PlaceboDrug
Part B - 0.2 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected intradermally (maximum 10 injection points, 2,0 mL maximum).
| Study group | Role | What they receive |
|---|---|---|
| Pre-Randomization, Run-In period (part A) | Experimental | Crossover run-in part A - Subjects will be injected (Test 1) with either saline or local anaesthetic (lidocaine). One week later, they will be crossed over, injected with the other agent (Test 2). Receives: Drug: Lidocaine; Drug: Placebo |
| Dysport dose 1 (part B) | Experimental | Dysport dose 1 as a single-dose, intradermal injection. Receives: Biological: Botulinum toxin type A |
| Dysport dose 2 (part B) | Experimental | Dysport dose 2 as a single-dose, intradermal injection. Receives: Biological: Botulinum toxin type A |
| Dysport dose 3 (part B) | Experimental | Dysport dose 3 as a single-dose, intradermal injection. Receives: Biological: Botulinum toxin type A |
| Placebo (saline solution) (part B) | Placebo comparator | Placebo single-dose, intradermal injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset of Effect in the Spontaneous Numerical Rating Scale (NRS) Score
The time to onset of effect was defined as the time to a decrease from baseline of two points or greater in the spontaneous NRS score. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Only descriptive statistical analysis was performed for this outcome measure.
Measured: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
Peak Effect in the Spontaneous NRS Score
The peak effect was defined as the maximal decrease from baseline in the spontaneous NRS score over a 12-hour period. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Greater reductions in change from baseline correspond to greater pain relief.
Measured: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
Time to Peak Effect in the Spontaneous NRS Score
The time to peak effect was defined as the time to reach the peak effect over a 12-hour period. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours."
Measured: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
Duration of Effect in the Spontaneous NRS Score
The duration of effect was defined as the duration between time to onset and last timepoint for which decrease from baseline in the spontaneous NRS score was two points or greater. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours."
Measured: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
Secondary outcomes (2)
Change From Baseline in the Spontaneous NRS Score Throughout the Study
Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Greater reductions in change from baseline correspond to greater pain relief.
Measured: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12
For stimulus-evoked NRS score during Quantitative Sensory Testing, participants were submitted to stimuli of various nature (light touch, pressure and temperature) applied to the painful area. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Static mechanical allodynia is the response to light sustained normally innocuous pressure against the skin. Dynamic mechanical allodynia is the response to a normally innocuous light moving mechanical stimulus on the skin. Temporal summation is a condition, which demonstrates an increased perception of pain to repetitive painful stimuli.
Measured: Part B: Baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) and Weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start30 Oct 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
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 Chronic Scar PainStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663101
- Sponsor's protocol ID
- D-FR-52120-244
- Other IDs
- 2018-001703-37, 2018
- Acronym
- PMOD03
- Status last verified
- Dec 2020
- First submitted
- 6 Sep 2018
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo Controlled, Proof-of-concept Study in Subjects With Abdominal or Thoracic Chronic Scar Pain to Assess the Analgesic Properties of Intradermal Doses of Dysport®
- ClinicalTrials.gov ID
- NCT03663101
- Acronym / sponsor ID
- PMOD03 / D-FR-52120-244
- Conditions
- Chronic Scar Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 4 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to determine whether a currently licensed version of botulinum toxin (Dysport®) is effective for the treatment of pain that has developed and/or persisted for months or years around the scar of a previous surgical site, and whether this condition could be suitable for the testing of similar new medicines. The study will compare three different doses of Dysport® to see if there is benefit and/or a best dose for treating persistent post-surgery scar pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pre-Randomization, Run-In period (part A) | Experimental | Drug: Lidocaine, Drug: PlaceboCrossover run-in part A - Subjects will be injected (Test 1) with either saline or local anaesthetic (lidocaine). One week later, they will be crossed over, injected with the other agent (Test 2). |
| Dysport dose 1 (part B) | Experimental | Biological: Botulinum toxin type ADysport dose 1 as a single-dose, intradermal injection. |
| Dysport dose 2 (part B) | Experimental | Biological: Botulinum toxin type ADysport dose 2 as a single-dose, intradermal injection. |
| Dysport dose 3 (part B) | Experimental | Biological: Botulinum toxin type ADysport dose 3 as a single-dose, intradermal injection. |
| Placebo (saline solution) (part B) | Placebo comparator | Drug: PlaceboPlacebo single-dose, intradermal injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects aged between 18 and 75 years inclusive at the time of giving informed consent.
- Subjects suffering from an area of chronic pain post-abdominal or thoracic surgery, chronic abdominal or thoracic scar pain.
- Longitudinal axis of the pain area of 10 cm long maximum (as mapped upon screening).
- Subjects with moderate to severe pain, i.e. spontaneous NRS score of 4-8 which has been stable for the previous month before screening.
- Stable use of analgesics (or any medication impacting pain perception) during the month before screening and expected to be stable for the study duration.
Key exclusion criteria (14 listed)
- Previous treatment with Botulinum neurotoxin (BTX) (any serotype) during the past six months before screening.
- History of hypersensitivity to any of the components of the Dysport formulation (which includes human serum albumin and lactose) or allergy to cow's milk protein.
- Known hypersensitivity to lidocaine or other anaesthetics of the amide type, known hypersensitivity to hydroxybenzoates, complete heart block, hypovolaemia.
- Any medical condition that may put the subject at risk with exposure to BTX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
- Opioid analgesic use at a Morphine Equivalent Dosage (MED) of >75mg per day.
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 |
|---|---|---|
| Lidocaine0.5 mL (2.5 mg) of lidocaine per injection point will be injected subcutaneously (maximum 10 injection points). | Drug | Pre-Randomization, Run-In period (part A) |
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®)0.2 mL of one of three different doses of Dysport per injection point will be injected intradermally (maximum 10 injection points). | Biological | Dysport dose 1 (part B), Dysport dose 2 (part B), Dysport dose 3 (part B) |
| PlaceboAlso: Saline solutionPart A - 0.5 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected subcutaneously (maximum 10 injection points). | Drug | Pre-Randomization, Run-In period (part A) |
| PlaceboPart B - 0.2 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected intradermally (maximum 10 injection points, 2,0 mL maximum). | Drug | Placebo (saline solution) (part B) |
Primary outcome
Time to Onset of Effect in the Spontaneous Numerical Rating Scale (NRS) Score
Time frame: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
The time to onset of effect was defined as the time to a decrease from baseline of two points or greater in the spontaneous NRS score. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Only descriptive statistical analysis was performed for this outcome measure.
Peak Effect in the Spontaneous NRS Score
Time frame: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
The peak effect was defined as the maximal decrease from baseline in the spontaneous NRS score over a 12-hour period. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Greater reductions in change from baseline correspond to greater pain relief.
Time to Peak Effect in the Spontaneous NRS Score
Time frame: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
The time to peak effect was defined as the time to reach the peak effect over a 12-hour period. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours."
Duration of Effect in the Spontaneous NRS Score
Time frame: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
The duration of effect was defined as the duration between time to onset and last timepoint for which decrease from baseline in the spontaneous NRS score was two points or greater. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours."
2 secondary outcomes
Change From Baseline in the Spontaneous NRS Score Throughout the Study
Time frame: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12
Time frame: Part B: Baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) and Weeks 6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- 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.
Ipsen Medical Director study director
Ipsen
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 Lidocaine and Botulinum toxin type A in people with Chronic Scar Pain, run by Ipsen at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 12 Jan 2021. 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 United Kingdom. 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 4 Dec 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?
Time to Onset of Effect in the Spontaneous Numerical Rating Scale (NRS) Score (time frame: Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.). The study lists 4 primary outcomes in all. 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 12 Jan 2021.