Neuropathic PainPhase 1SPICENCT03899246
Sickle Cell Pain: Intervention With Capsaicin Exposure
A Phase 1 study testing Eight Percent Topical Capsaicin in people with Neuropathic Pain and Sickle Cell Disease, run by Children's Hospital of Michigan at 1 site in United States.
Trial summary
This study evaluates the safety and feasibility of using high dose topical capsaicin patches for the treatment of neuropathic pain in pediatric patients with sickle cell disease, as well as the feasibility of using a number of tests for the evaluation and monitoring of neuropathic pain. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Neuropathic Pain, Sickle Cell Disease
- What is being tested?
- Eight Percent Topical Capsaicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2019to 30 Mar 2020
- Phase
- Phase 1
- 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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A diagnosis of either Sickle Cell Disease with genotype SS or S Beta-zero, or SC disease.
- Must have recurrent sites of pain, where majority of acute pain episodes are localized
- Subjects are willing and able to comply with scheduled visits, treatment plan, laboratory tests, pain assessments, and other study procedures.
- Subjects who are being treated with hydroxyurea (HU) must have been on a stable dose for at least 8 weeks prior to Visit 1 (Day 0), with the intent of remaining on the same dose of hydroxyurea throughout the clinical trial including the protocol-specified follow-up period unless adjustments are medically necessary due to bone marrow suppression.
- At least 80% compliance (defined as logging pain at least once daily) with mobile application use during 14-day lead in period from time of enrollment to time of first capsaicin application.
Who cannot join
- Age less than 14 or greater than 21
- History of major surgery within the past 3 months.
- Patients receiving scheduled chronic partial exchange transfusions as part of their sickle cell disease management protocol.
- Concurrently taking another medication used in the treatment of neuropathic pain or with the potential to affect the peripheral nervous system (e.g. gabapentin, anti-epileptics, antidepressants, systemic alpha or beta adrenergic receptor blockers)
- Use of another topical analgesic at home in the treatment of pain episodes such as topical lidocaine, diclofenac, or menthol (must discontinue use at the time of enrollment).
- Recurrent pain secondary to an underlying condition other than vaso-occlusive pain (avascular necrosis, scoliosis, fracture, etc.)
Show all 12Show fewer
- Patients lacking the mental capacity to assent to the study
- Patients with another chronic inflammatory/immune disorder that could skew the inflammatory markers listed above.
- Pregnant females
- Expectation that the subject will not be able to be followed for the duration of the study
- Active use of illicit drugs and/or alcohol dependence, as determined by the investigator. Opioid use beyond the amount necessary for pain related to the underlying sickle cell disease as determined by the investigator.
- Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
Official title: Safety and Feasibility of High-Dose Topical Capsaicin for the Treatment of Neuropathic Pain in Pediatric Sickle Cell Disease
This study evaluates the safety and feasibility of using high dose topical capsaicin patches for the treatment of neuropathic pain in pediatric patients with sickle cell disease, as well as the feasibility of using a number of tests for the evaluation and monitoring of neuropathic pain. The hypothesis, based on evidence obtained from studies in adults with neuropathic pain related to other diseases as well as a single previously published study of capsaicin in pediatric patients, is that capsaicin will be well tolerated in this population. Additionally, it is hypothesized that it is feasible to monitor changes in neuropathic pain via the testing listed below.
Read the detailed description
Patients with sickle cell disease suffer debilitating painful episodes, as well as chronic, often daily, pain that are commonly treated with non-steroidal anti-inflammatory drugs, opioids, and other non-pharmacologic supportive measures. Neuropathic pain has been shown to be present in these patients, with frequency increasing with age. It is believed, based on knowledge of neuropathic pain related to other conditions and from the small number of studies in sickle cell patients, to result from repeated vaso-occlusive pain episodes that prime central and peripheral pain sensing pathways in a maladaptive manner, leading to hyper-sensitization. Very few studies to date have evaluated therapies specifically targeting this aspect of the pain experienced by patients with sickle cell disease.
This is a pilot study for a future longitudinal study of neuropathic pain in pediatric patients with sickle cell disease. The first aim of this pilot study is to establish the safety of treating participants with sickle cell disease aged fourteen to twenty-one with eight percent topical capsaicin patches on an every three-month dosing schedule as recommended by the manufacturer. This will be a single-arm safety study. Presence of neuropathic pain will be determined by day zero evaluation via the testing shown in the outcome measures below. Topical medication will be administered over one hour, every three months, for six months (total of three applications), to sites of recurrent vaso-occlusive pain, according to the package insert administration guidelines. Subjective and objective evaluations of pain and inflammation including questionnaires, blood tests, and quantitative sensory testing will be carried out every six weeks throughout the study period until twelve weeks after the final capsaicin application. Additionally, participants will record daily pain and medication use in a mobile app. Safety will be established by there being no grade three or four adverse events according to CTCAE definitions. Grade two adverse events will be evaluated on a case by case basis throughout the duration of the study. Feasibility of monitoring neuropathic pain with the aforementioned studies will be established by participant compliance with greater than eighty percent of all study activities.
- Conditions
- Neuropathic Pain, Sickle Cell Disease
- Being tested
- Eight Percent Topical Capsaicin
- Keywords
- Capsaicin, Topical Analgesia, Quantitative Sensory Testing, Pain
- Medical subject headings
- Neuralgia, Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eight Percent Topical CapsaicinDrug
Also called Qutenza
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin Arm | Experimental | Single arm to receive eight percent topical capsaicin applied to up to 4 sites of recurrent pain over one hour on an every three month schedule. Participants in this arm will receive pretreatment with topical five percent lidocaine. Receives: Drug: Eight Percent Topical Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteria
Safety will be established by there being no treatment-related adverse events greater than grade 2 using CTCAE definitions of adverse events. Grade 2 CTCAE events will be evaluated on a case by case basis to determine safety of continuing the study. Grade 3 events will result in immediate suspension of study activities until a full analysis of the event in question is completed.
Measured: At the end of the 9 month study period all participant information will be reviewed and adverse events assessed.
Compliance with Serum Substance P Levels
Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including serum substance P levels.
Measured: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed.
Compliance with Subjective Neuropathic Pain Questionnaire
Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including completion of PainDETECT Questionnaire during study visits. The questionnaire is a validated assessment of neuropathic pain. It consists of a series of questions regarding the experience of pain for which the participant will provide an answer ranging from "never" (0 points) to "very strongly" (5 points). Points are added to provide a total score from 0 to 38. A score from 0 to 12 indicates a neuropathic pain component is unlikely, a score of 12 to 18 is equivocal, and a score greater than 18 indicates a neuropathic component is likely.
Measured: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed.
Compliance with Quantitative Sensory Testing
Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including quantitative sensory testing using electronic von frey machine.
Measured: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed.
Secondary outcomes (3)
Compliance with Mobile App Record Keeping
Feasibility, as above, will be established by greater than 80 percent compliance with daily mobile app recordings of pain and home medication use.
Measured: Duration of study period (9 months). Mobile app recordings can be reviewed in real time and will be recorded on a weekly basis.
Compliance with Blood Draws for Hyperspectral Imaging Analysis for Determining Presence and Improvement of Chronic Neuropathic Pain
Feasibility will be established by the successful processing of greater than 80 percent of target number of blood samples to be sent for hyperspectral analysis, a novel test capable of detecting chronic pain states, but not yet used in the sickle cell population.
Measured: Duration of study period (9 months). Will be drawn and processed at 6 week intervals throughout the study period.
Morphine Equivalents Utilized
Will assess changes in pain medication required during the course of the study period based on electronic medical record, participant report, and controlled substance monitoring database.
Measured: Duration of study period (9 months). Will be evaluated at 6 week intervals throughout the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start3 Jul 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, safety and feasibility trial assessing the suitability of an FDA approved medication for use in children with an off-label condition.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Glaros, Children's Hospital of Michigan
- Investigators
- Alexander K Glaros, MD, Principal investigator, Children's Hospital of MichiganAhmar U Zaidi, MD, Principal investigator, Children's Hospital of MichiganCallaghan Michael, MD, Principal investigator, Children's Hospital of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899246
- Sponsor's protocol ID
- SPICE1.0
- Acronym
- SPICE
- Status last verified
- Jul 2020
- First submitted
- 25 Jan 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith WR, Bovbjerg VE, Penberthy LT, McClish DK, Levenson JL, Roberts JD, Gil K, Roseff SD, Aisiku IP. Understanding pain and improving management of sickle cell disease: the PiSCES study. J Natl Med Assoc. 2005 Feb;97(2):183-93.
PubMed 15712781Franck LS, Treadwell M, Jacob E, Vichinsky E. Assessment of sickle cell pain in children and young adults using the adolescent pediatric pain tool. J Pain Symptom Manage. 2002 Feb;23(2):114-20. doi: 10.1016/s0885-3924(01)00407-9.
PubMed 11844631Brandow AM, Farley RA, Panepinto JA. Neuropathic pain in patients with sickle cell disease. Pediatr Blood Cancer. 2014 Mar;61(3):512-7. doi: 10.1002/pbc.24838. Epub 2013 Oct 26.
PubMed 24167104Brandow AM, Zappia KJ, Stucky CL. Sickle cell disease: a natural model of acute and chronic pain. Pain. 2017 Apr;158 Suppl 1(Suppl 1):S79-S84. doi: 10.1097/j.pain.0000000000000824. No abstract available.
PubMed 28221286Antunes FD, Propheta VGS, Vasconcelos HA, Cipolotti R. Neuropathic pain in patients with sickle cell disease: a cross-sectional study assessing teens and young adults. Ann Hematol. 2017 Jul;96(7):1121-1125. doi: 10.1007/s00277-017-2984-z. Epub 2017 Mar 30.
PubMed 28361297Brandow AM, Farley RA, Panepinto JA. Early insights into the neurobiology of pain in sickle cell disease: A systematic review of the literature. Pediatr Blood Cancer. 2015 Sep;62(9):1501-11. doi: 10.1002/pbc.25574. Epub 2015 May 13.
PubMed 25976161Kenyon N, Wang L, Spornick N, Khaibullina A, Almeida LE, Cheng Y, Wang J, Guptill V, Finkel JC, Quezado ZM. Sickle cell disease in mice is associated with sensitization of sensory nerve fibers. Exp Biol Med (Maywood). 2015 Jan;240(1):87-98. doi: 10.1177/1535370214544275. Epub 2014 Jul 28.
PubMed 25070860Garrison SR, Kramer AA, Gerges NZ, Hillery CA, Stucky CL. Sickle cell mice exhibit mechanical allodynia and enhanced responsiveness in light touch cutaneous mechanoreceptors. Mol Pain. 2012 Sep 10;8:62. doi: 10.1186/1744-8069-8-62.
PubMed 22963123Campbell CM, Moscou-Jackson G, Carroll CP, Kiley K, Haywood C Jr, Lanzkron S, Hand M, Edwards RR, Haythornthwaite JA. An Evaluation of Central Sensitization in Patients With Sickle Cell Disease. J Pain. 2016 May;17(5):617-27. doi: 10.1016/j.jpain.2016.01.475. Epub 2016 Feb 16.
PubMed 26892240Henrich F, Magerl W, Klein T, Greffrath W, Treede RD. Capsaicin-sensitive C- and A-fibre nociceptors control long-term potentiation-like pain amplification in humans. Brain. 2015 Sep;138(Pt 9):2505-20. doi: 10.1093/brain/awv108. Epub 2015 May 4.
PubMed 25943423Jara-Oseguera A, Simon SA, Rosenbaum T. TRPV1: on the road to pain relief. Curr Mol Pharmacol. 2008 Nov;1(3):255-69. doi: 10.2174/1874467210801030255.
PubMed 20021438Jessell TM. Substance P in nociceptive sensory neurons. Ciba Found Symp. 1982;(91):225-48. doi: 10.1002/9780470720738.ch13.
PubMed 6183072Yaksh TL, Farb DH, Leeman SE, Jessell TM. Intrathecal capsaicin depletes substance P in the rat spinal cord and produces prolonged thermal analgesia. Science. 1979 Oct 26;206(4417):481-3. doi: 10.1126/science.228392.
PubMed 228392Jessell TM, Iversen LL, Cuello AC. Capsaicin-induced depletion of substance P from primary sensory neurones. Brain Res. 1978 Aug 18;152(1):183-8. doi: 10.1016/0006-8993(78)90146-4. No abstract available.
PubMed 209869Simone DA, Nolano M, Johnson T, Wendelschafer-Crabb G, Kennedy WR. Intradermal injection of capsaicin in humans produces degeneration and subsequent reinnervation of epidermal nerve fibers: correlation with sensory function. J Neurosci. 1998 Nov 1;18(21):8947-59. doi: 10.1523/JNEUROSCI.18-21-08947.1998.
PubMed 9787000
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of High-Dose Topical Capsaicin for the Treatment of Neuropathic Pain in Pediatric Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03899246
- Acronym / sponsor ID
- SPICE / SPICE1.0
- Conditions
- Neuropathic Pain, Sickle Cell Disease
- Keywords
- Capsaicin, Topical Analgesia, Quantitative Sensory Testing, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospital of MichiganUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and feasibility of using high dose topical capsaicin patches for the treatment of neuropathic pain in pediatric patients with sickle cell disease, as well as the feasibility of using a number of tests for the evaluation and monitoring of neuropathic pain. The hypothesis, based on evidence obtained from studies in adults with neuropathic pain related to other diseases as well as a single previously published study of capsaicin in pediatric patients, is that capsaicin will be well tolerated in this population. Additionally, it is hypothesized that it is feasible to monitor changes in neuropathic pain via the testing listed below.
Detailed description
Patients with sickle cell disease suffer debilitating painful episodes, as well as chronic, often daily, pain that are commonly treated with non-steroidal anti-inflammatory drugs, opioids, and other non-pharmacologic supportive measures. Neuropathic pain has been shown to be present in these patients, with frequency increasing with age. It is believed, based on knowledge of neuropathic pain related to other conditions and from the small number of studies in sickle cell patients, to result from repeated vaso-occlusive pain episodes that prime central and peripheral pain sensing pathways in a maladaptive manner, leading to hyper-sensitization. Very few studies to date have evaluated therapies specifically targeting this aspect of the pain experienced by patients with sickle cell disease.
This is a pilot study for a future longitudinal study of neuropathic pain in pediatric patients with sickle cell disease. The first aim of this pilot study is to establish the safety of treating participants with sickle cell disease aged fourteen to twenty-one with eight percent topical capsaicin patches on an every three-month dosing schedule as recommended by the manufacturer. This will be a single-arm safety study. Presence of neuropathic pain will be determined by day zero evaluation via the testing shown in the outcome measures below. Topical medication will be administered over one hour, every three months, for six months (total of three applications), to sites of recurrent vaso-occlusive pain, according to the package insert administration guidelines. Subjective and objective evaluations of pain and inflammation including questionnaires, blood tests, and quantitative sensory testing will be carried out every six weeks throughout the study period until twelve weeks after the final capsaicin application. Additionally, participants will record daily pain and medication use in a mobile app. Safety will be established by there being no grade three or four adverse events according to CTCAE definitions. Grade two adverse events will be evaluated on a case by case basis throughout the duration of the study. Feasibility of monitoring neuropathic pain with the aforementioned studies will be established by participant compliance with greater than eighty percent of all study activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, safety and feasibility trial assessing the suitability of an FDA approved medication for use in children with an off-label condition.
| Arm | Type | Receives |
|---|---|---|
| Capsaicin Arm | Experimental | Drug: Eight Percent Topical CapsaicinSingle arm to receive eight percent topical capsaicin applied to up to 4 sites of recurrent pain over one hour on an every three month schedule. Participants in this arm will receive pretreatment with topical five percent lidocaine. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- A diagnosis of either Sickle Cell Disease with genotype SS or S Beta-zero, or SC disease.
- Must have recurrent sites of pain, where majority of acute pain episodes are localized
- Subjects are willing and able to comply with scheduled visits, treatment plan, laboratory tests, pain assessments, and other study procedures.
- Subjects who are being treated with hydroxyurea (HU) must have been on a stable dose for at least 8 weeks prior to Visit 1 (Day 0), with the intent of remaining on the same dose of hydroxyurea throughout the clinical trial including the protocol-specified follow-up period unless adjustments are medically necessary due to bone marrow suppression.
- At least 80% compliance (defined as logging pain at least once daily) with mobile application use during 14-day lead in period from time of enrollment to time of first capsaicin application.
Key exclusion criteria (12 listed)
- Age less than 14 or greater than 21
- History of major surgery within the past 3 months.
- Patients receiving scheduled chronic partial exchange transfusions as part of their sickle cell disease management protocol.
- Concurrently taking another medication used in the treatment of neuropathic pain or with the potential to affect the peripheral nervous system (e.g. gabapentin, anti-epileptics, antidepressants, systemic alpha or beta adrenergic receptor blockers)
- Use of another topical analgesic at home in the treatment of pain episodes such as topical lidocaine, diclofenac, or menthol (must discontinue use at the time of enrollment).
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 |
|---|---|---|
| Eight Percent Topical CapsaicinAlso: QutenzaSee arm description | Drug | Capsaicin Arm |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteria
Time frame: At the end of the 9 month study period all participant information will be reviewed and adverse events assessed.
Safety will be established by there being no treatment-related adverse events greater than grade 2 using CTCAE definitions of adverse events. Grade 2 CTCAE events will be evaluated on a case by case basis to determine safety of continuing the study. Grade 3 events will result in immediate suspension of study activities until a full analysis of the event in question is completed.
Compliance with Serum Substance P Levels
Time frame: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed.
Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including serum substance P levels.
Compliance with Subjective Neuropathic Pain Questionnaire
Time frame: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed.
Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including completion of PainDETECT Questionnaire during study visits. The questionnaire is a validated assessment of neuropathic pain. It consists of a series of questions regarding the experience of pain for which the participant will provide an answer ranging from "never" (0 points) to "very strongly" (5 points). Points are added to provide a total score from 0 to 38. A score from 0 to 12 indicates a neuropathic pain component is unlikely, a score of 12 to 18 is equivocal, and a score greater than 18 indicates a neuropathic component is likely.
Compliance with Quantitative Sensory Testing
Time frame: At the end of the 9 month study period all participant information will be reviewed and compliance with testing assessed.
Feasibility will be established by participants having greater than 80 percent compliance with all study investigations, including quantitative sensory testing using electronic von frey machine.
3 secondary outcomes
Compliance with Mobile App Record Keeping
Time frame: Duration of study period (9 months). Mobile app recordings can be reviewed in real time and will be recorded on a weekly basis.
Compliance with Blood Draws for Hyperspectral Imaging Analysis for Determining Presence and Improvement of Chronic Neuropathic Pain
Time frame: Duration of study period (9 months). Will be drawn and processed at 6 week intervals throughout the study period.
Morphine Equivalents Utilized
Time frame: Duration of study period (9 months). Will be evaluated at 6 week intervals throughout the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Background: PubMed 15712781Smith WR, Bovbjerg VE, Penberthy LT, McClish DK, Levenson JL, Roberts JD, Gil K, Roseff SD, Aisiku IP. Understanding pain and improving management of sickle cell disease: the PiSCES study. J Natl Med Assoc. 2005 Feb;97(2):183-93.
- Background: PubMed 11844631Franck LS, Treadwell M, Jacob E, Vichinsky E. Assessment of sickle cell pain in children and young adults using the adolescent pediatric pain tool. J Pain Symptom Manage. 2002 Feb;23(2):114-20. doi: 10.1016/s0885-3924(01)00407-9.
- Background: PubMed 24167104Brandow AM, Farley RA, Panepinto JA. Neuropathic pain in patients with sickle cell disease. Pediatr Blood Cancer. 2014 Mar;61(3):512-7. doi: 10.1002/pbc.24838. Epub 2013 Oct 26.
- Background: PubMed 28221286Brandow AM, Zappia KJ, Stucky CL. Sickle cell disease: a natural model of acute and chronic pain. Pain. 2017 Apr;158 Suppl 1(Suppl 1):S79-S84. doi: 10.1097/j.pain.0000000000000824. No abstract available.
- Background: PubMed 28361297Antunes FD, Propheta VGS, Vasconcelos HA, Cipolotti R. Neuropathic pain in patients with sickle cell disease: a cross-sectional study assessing teens and young adults. Ann Hematol. 2017 Jul;96(7):1121-1125. doi: 10.1007/s00277-017-2984-z. Epub 2017 Mar 30.
- Background: PubMed 25976161Brandow AM, Farley RA, Panepinto JA. Early insights into the neurobiology of pain in sickle cell disease: A systematic review of the literature. Pediatr Blood Cancer. 2015 Sep;62(9):1501-11. doi: 10.1002/pbc.25574. Epub 2015 May 13.
- Background: PubMed 25070860Kenyon N, Wang L, Spornick N, Khaibullina A, Almeida LE, Cheng Y, Wang J, Guptill V, Finkel JC, Quezado ZM. Sickle cell disease in mice is associated with sensitization of sensory nerve fibers. Exp Biol Med (Maywood). 2015 Jan;240(1):87-98. doi: 10.1177/1535370214544275. Epub 2014 Jul 28.
- Background: PubMed 22963123Garrison SR, Kramer AA, Gerges NZ, Hillery CA, Stucky CL. Sickle cell mice exhibit mechanical allodynia and enhanced responsiveness in light touch cutaneous mechanoreceptors. Mol Pain. 2012 Sep 10;8:62. doi: 10.1186/1744-8069-8-62.
- Background: PubMed 26892240Campbell CM, Moscou-Jackson G, Carroll CP, Kiley K, Haywood C Jr, Lanzkron S, Hand M, Edwards RR, Haythornthwaite JA. An Evaluation of Central Sensitization in Patients With Sickle Cell Disease. J Pain. 2016 May;17(5):617-27. doi: 10.1016/j.jpain.2016.01.475. Epub 2016 Feb 16.
- Background: PubMed 25943423Henrich F, Magerl W, Klein T, Greffrath W, Treede RD. Capsaicin-sensitive C- and A-fibre nociceptors control long-term potentiation-like pain amplification in humans. Brain. 2015 Sep;138(Pt 9):2505-20. doi: 10.1093/brain/awv108. Epub 2015 May 4.
- Background: PubMed 20021438Jara-Oseguera A, Simon SA, Rosenbaum T. TRPV1: on the road to pain relief. Curr Mol Pharmacol. 2008 Nov;1(3):255-69. doi: 10.2174/1874467210801030255.
- Background: PubMed 6183072Jessell TM. Substance P in nociceptive sensory neurons. Ciba Found Symp. 1982;(91):225-48. doi: 10.1002/9780470720738.ch13.
- 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.
Alexander K Glaros, MD principal investigator
Children's Hospital of Michigan
Ahmar U Zaidi, MD principal investigator
Children's Hospital of Michigan
Callaghan Michael, MD principal investigator
Children's Hospital of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eight Percent Topical Capsaicin in people with Neuropathic Pain and Sickle Cell Disease, run by Children's Hospital of Michigan at 1 site 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 5 inclusion and 12 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 29 Jul 2020. 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteria (time frame: At the end of the 9 month study period all participant information will be reviewed and adverse events assessed.). 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?
On the ClinicalTrials.gov record for NCT03899246, which also lists 24 linked publications.
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 29 Jul 2020.