Pain, NeuropathicPhase 3NCT03928093
Pregabalin Treatment for RDEB Pain and Itch
A Phase 3 study testing Pregabalin in people with Pain, Neuropathic and Itch, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Recessive dystrophic epidermolysis bullosa (RDEB) patients' quality of life is severely affected by neuropathic pain and itch, which have recently been demonstrated to be secondary to skin small fiber neuropathy. To date, there is no evidence on what the best agent is to control these symptoms. Read more about this study
- Who is it for?
- Ages 8 to 40 years
- Conditions the study is for
- Pain, Neuropathic, Itch, Epidermolysis Bullosa
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2019to 1 Feb 2024
- Phase
- Phase 3
- 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 8 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: > 8 - 40 years (we selected this range due to lack of data in younger population and the difficulty in getting patient reported outcomes in younger patients)
- Diagnosis of RDEB (by a dermatologist and/or EB specialist and/or genetic confirmation)
- Evidence of neuropathy defined by: thermal sensory loss (determined by a thermal roller, ROLLTEMP2, Sometic, Sweden) 14 and > 4/10 score using a screening tool for neuropathic pain, the DN4 questionnaire 15
- Pain intensity of > 4/10 on a 0-10 VAS scale measured daily (reduced frequency is also acceptable) at night over 2 weeks
- Itch intensity of > 4/10 on a 0-10 VAS scale measures daily (reduced frequency is also acceptable) at night over 2 weeks
- Consent to follow with study procedures
Who cannot join
- Intolerance and/or allergy to Pregabalin or gabapentin
- Lactose intolerance (placebo capsules contain lactose)
- Pregabalin use within 2 weeks before study enrolment
- Ongoing treatment with gabapentin, amitriptyline, duloxetine, nortriptyline, other tricyclics or SNRIs
- Medical conditions that would be considered as contraindications for pregabalin treatment (ischemic heart disease, cardiac dysrhythmia, glaucoma, history of urinary retention)
- Pregnancy
- History of use of restrictive substances or alcohol abuse
- Allergy to gelatin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Cross-over, Feasibility Trial of Pregabalin for the Treatment of Recessive Dystrophic Epidermolysis Bullosa-associated Neuropathic Pain and Itch
Recessive dystrophic epidermolysis bullosa (RDEB) patients' quality of life is severely affected by neuropathic pain and itch, which have recently been demonstrated to be secondary to skin small fiber neuropathy. To date, there is no evidence on what the best agent is to control these symptoms. Based on the anecdotal data and safety profile, the investigators believe that pregabalin is a therapeutic agent that will be effective and safe in this population. The investigators propose to conduct a blinded study, using pregabalin versus placebo in which each patient serves as its own control (cross-over design). This is a feasibility study that will provide preliminary data on efficacy and safety of pregabalin in RDEB patients with neuropathic pain and itch and gather much needed data (dosage, titration schedule, outcome measures, etc) to inform the design of a larger cohort, controlled, multicenter trial.
Read the detailed description
Neuropathic pain and itch are significant symptoms that affect RDEB patients' quality of life. To date, there is no evidence on what the best agent is to control these symptoms.
Based on the anecdotal data and the safety profile, the investigator believes that pregabalin is a therapeutic agent that will be effective and safe in this population.
This is a pilot, randomized, double-blinded, cross-over trial of pregabalin vs placebo for the treatment of RDEB associated neuropathic pain and itch. The study will run for 24 weeks and will have 4 separate phases with 6 overall visits: 1. Observation/wash out period (2 weeks); 2. ARM-1, ½ of the patients will receive pregabalin(A) and ½ the placebo (B) (10 weeks); 3. Wash out period (2 weeks) and 4. ARM-2 (patients who received placebo will receive pregabalin and pregabalin will receive placebo (10 weeks).
Patients will be recruited during the regular clinic visits or invited to participate via a letter followed by 2 phone calls.
- Screening/Wash out period #1 (Visit 0)to assess eligibility criteria and the background pain and itch level (2 weeks), as well as the effectiveness of patients' "standard pain/itch interventions". Throughout this phase and the rest of the study, patients will receive pain and itch medications, except those that interfere with the pregabalin (see exclusion criteria).
- Investigators will assess the eligibility criteria, including having moderate to severe pain (>4/10), the evidence of neuropathy using a thermal roller device ROLLTEMP2, Sometic, and a screening tool for neuropathic pain, the DN4 questionnaire 15 (Appendix 2).
- Investigators will collect basic demographic data, medication information and disease severity using iscorEB clinician portion, a valid outcome measure that evaluates the disease severity 16 and EBDASI 17 ( Data collection form: Baseline/Screening Form)
- Patients will be asked to report on their disease severity using iscorEB patient portion (all ages) that includes pain and itch domains and QOLEB 18 for those over 18 years of age (validated only for the adult population).
- Patients will be instructed how to collect daily assessments of pain and itching for 14 days before the next visit. For the overall pain intensity assessment, the investigators will use a 100mm VAS, where 0 is no pain and 10- the worst pain ever experienced. For itch assessments, the investigators will ask patients to score each day, before going to bed, the degree of itching experienced that day using a 100 mm horizontal VAS where 0 is no itch and 10 is the worst itch.19 The investigators chose the single item for its reliability, validity and responsiveness to change. These values will represent patient's baseline pain (AvePain-00) and itch (AveItch-00).
- ARM1 intervention study period (Visits 1 \& 2): ½ of the patients will receive the active intervention (Pregabalin) and ½ the placebo. This phase will be of 10 weeks duration and will consist of 4 weeks of escalating dose until the desired maximum, 4 weeks of active treatment and 2 weeks of titration down (see titration schedule in the Appendix 1)Patients will receive either active intervention (pregabalin) or placebo including instruction of how to administer them. Visit 1: (Week 2)
- Investigator will collect the data on pain and itching from the 2 weeks wash-out and will determine the average pain and itching of approximately 14 days prior to the study visit 1(AvePain-00, AveItch-00)
- Patients will be asked to report on their disease severity using iscorEB patient portion and QOLEB for those over 18 years of age.
- A team member will call patient twice a week during the escalation phase to inquire about adverse events
- Patients will be instructed to collect daily assessments of pain, and itch for 7 days before next visit (~from weeks 9-10). Visit 2: (Week 10)
- Patients will be instructed to contact investigator if experiencing any adverse events.
- Investigator will collect the data on pain and itching from approximately 7 days prior to visit 2 (~weeks 9-10) and will determine the average pain and itching (AvePain-02, AveItch-02)
- Patients will be asked to report on their disease severity using iscorEB patient portion and QOLEB for those over 18 years of age.
- Adverse events (see potential risks, DCF follow up, patient's diary)
- Patients will be instructed to collect daily assessments of pain, and itch for 7 days before next visit (~from weeks 13-14)
- Wash out period #2 (2 weeks) Visit 3 (Week 14)
- Investigator will collect the data on pain and itching and will determine the average pain and itching of approximately 7 days prior to the study visit 3 (AvePain-03, AveItch-03)
- Patients will be asked to report on their disease severity using iscorEB patient portion and QOLEB for those over 18 years of age.
- Investigator will collect adverse events (see potential risks, DCF follow up, patient's diary)
- Patients will be instructed to collect daily assessments of pain, and itch for 7 days before next visit (~from weeks 21-22)
- All study procedures at visit 3 will be similar to visit 1.
- ARM2 intervention study period (Visits 4 \& 5 (Week 22 and 24): patients randomized to placebo will receive pregabalin and those on placebo will get the pregabalin conducted similarly as in ARM1
- All study procedures at visit 4 will be similar to visit 2
- The outcome measures will be similar, but will be recorded as (AvePain-04, AveItch-04)
- Weaning will be similar to ARM1
- End of the Study visit: Visit 5 (Week 24) The outcome measures will be similar, but will be recorded as AvePain-05, AveItch-05)
- Conditions
- Pain, Neuropathic, Itch, Epidermolysis Bullosa
- Being tested
- Pregabalin
- Medical subject headings
- Neuralgia, Pruritus, Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Placebo
Pregabalin /placebo capsules will be taken by mouth and will be prescribed for the study participants in the doses, depending on their weight and treatment phase: Participant < 25 kg at baseline will start with 50 mg per day, increasing the dose by 50 mg each week until their maximum dose 200 mg per day; Participants who are greater than or equal to 25 kg at baseline will start with 100 mg per day, increasing their dose by 50 mg each week until their target dose 300 mg per day is achieved. The study medication will be taken twice per day.The dose will be weaned down every 1-2 days by 25 mg in the last two weeks of each treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin followed by placebo | Experimental | The study has a crossover design. Participants in this arm will receive pregabalin during the first study treatment period for ten weeks and placebo during their second ten-week treatment period . The dose will depend on the participant's weight and phase of treatment period. Each treatment period consists of 4 weeks of escalating dose until the desired maximum , 4 weeks of active treatment and 2 weeks of titrating down. Receives: Drug: Pregabalin |
| Placebo followed by Pregabalin | Experimental | Participants will receive placebo during the first treatment period of the study(10 weeks) followed by 10 weeks of pregabalin treatment . The dose will depend on the participant's weight and phase of the treatment period . Each treatment period consists of 3 phases: 4 weeks of escalating dose until the desired maximum, 4 weeks of active treatment and 2 weeks of titrating down. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the mean pain scores between pregabalin and placebo group: VAS
It will be measured as difference in the mean pain values pre- and post-intervention for each group using the Visual Analog Scale (VAS).It is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain ever). The patient is asked to mark their pain level on the line.The pain is scored using the VAS by measuring the distance in centimeters (0-10) from the "no pain" anchoring point.
Measured: 12 weeks
Secondary outcomes (8)
Proportion of patients on pregabalin achieving a ≥75% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out
Proportion of patients on pregabalin achieving a ≥75% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out
Measured: 12 weeks
Proportion of patients on pregabalin achieving a ≥50% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out
Proportion of patients on pregabalin achieving a ≥50% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out
Measured: 12 weeks
Difference in the average pain score assessed using VAS between first and second treatment periods (period effect)
Difference in the average pain score assessed using VAS, reported by the patient between first and second treatment periods. Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (0 -no pain) and on the right (10- worst pain ever). The patient is asked to mark their pain level on the line. The pain is scored using the VAS by measuring the distance in centimeters (0-10) from the "no pain" anchoring point.
Measured: 24 weeks
Proportion of patients on pregabalin achieving a ≥75% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out
Proportion of patients on pregabalin achieving a ≥75% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out.The intensity of itch is measured using the Visual Analog Scale for itch(VAS).It is a 10 cm line with anchor statements on the left (no itching) and on the right (worst possible itching). The patient is asked to mark the intensity of itch on the line. The itch is scored using the VAS by measuring the distance in centimeters (0-10)from the "no itch" anchoring point.
Measured: 24 weeks
Proportion of patients on pregabalin achieving a ≥50% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out
Proportion of patients on pregabalin achieving a ≥50% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out
Measured: 12 weerks
Difference in the average itch score as assessed using VAS between the first and the second treatment periods (period effect).
Difference in the average itch score as assessed using VAS( reported by the patient) between the first and the second treatment periods (period effect). The intensity of itch is measured using the Visual Analog Scale for itch (VAS).It is a 10 cm line with anchor statements on the left (0- no itching) and on the right (10 -worst possible itching). The patient is asked to mark the intensity of itch on the line. The itch is scored using the VAS by measuring the distance in centimeters (0-10) from the "no itch" anchoring point.
Measured: 24 weeks
Changes in the Quality of Life in Epidermolysis Bullosa Questionnaire score(QOLEB) for patients >18yrs in the intervention versus placebo
Changes in the QOLEB for patients >18yrs in the intervention versus placebo. QOLEB is a measurement tool containing 17questions.Each question has a score range from 0-3.Total score range is between 0 and 51.
iscorEB is a measurement tool for evaluating the disease severity in EB patient.It evaluates the cutaneous,mucosal and other organ impact of EB and includes clinician and patient reported outcomes in a single instrument. Score ranges between 0-120 for both reported outcomes.
Measured: 24 weeks
Changes in iscorEB (instrument for scoring clinical outcomes for research of EB), patient portion score in the intervention versus placebo
iscorEB is a measurement tool for evaluating the disease severity in EB patient. It evaluates the cutaneous, mucosal and other organ impact of EB and includes clinician and patient reported outcomes in a single instrument. Score ranges between 0-120 for both reported outcomes. Patient portion of this instrument contains 15 questions. Each question has a score range from 0-8.Total score range for iscorEB patient portion is between 0 and 120. Reduction in iscorEB scores indicates improvement. An increase in score indicates deterioration.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start7 Aug 2019
- Primary completion1 Mar 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, NeuropathicStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- there two treatment periods in the study. All of the study participants will receive pregabalin treatment during one of these two 10-week treatment periods, and placebo - during the other one.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemolysis Bullosa Research Partnership
- Responsible party
- Principal investigator, Elena Pope, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928093
- Sponsor's protocol ID
- 1000060628
- Status last verified
- Jan 2025
- First submitted
- 27 Mar 2019
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calvo M, Tejos-Bravo M, Passi-Solar A, Espinoza F, Fuentes I, Lara-Corrales I, Pope E. Pregabalin for Neuropathic Pain and Itch in Recessive Dystrophic Epidermolysis Bullosa: A Randomized Crossover Trial. JAMA Dermatol. 2024 Dec 1;160(12):1314-1319. doi: 10.1001/jamadermatol.2024.3767.
PubMed 39441591
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Cross-over, Feasibility Trial of Pregabalin for the Treatment of Recessive Dystrophic Epidermolysis Bullosa-associated Neuropathic Pain and Itch
- ClinicalTrials.gov ID
- NCT03928093
- Acronym / sponsor ID
- 1000060628
- Conditions
- Pain, Neuropathic, Itch, Epidermolysis Bullosa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Epidemolysis Bullosa Research Partnership
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 25 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.
Recessive dystrophic epidermolysis bullosa (RDEB) patients' quality of life is severely affected by neuropathic pain and itch, which have recently been demonstrated to be secondary to skin small fiber neuropathy. To date, there is no evidence on what the best agent is to control these symptoms. Based on the anecdotal data and safety profile, the investigators believe that pregabalin is a therapeutic agent that will be effective and safe in this population. The investigators propose to conduct a blinded study, using pregabalin versus placebo in which each patient serves as its own control (cross-over design). This is a feasibility study that will provide preliminary data on efficacy and safety of pregabalin in RDEB patients with neuropathic pain and itch and gather much needed data (dosage, titration schedule, outcome measures, etc) to inform the design of a larger cohort, controlled, multicenter trial.
Detailed description
Neuropathic pain and itch are significant symptoms that affect RDEB patients' quality of life. To date, there is no evidence on what the best agent is to control these symptoms.
Based on the anecdotal data and the safety profile, the investigator believes that pregabalin is a therapeutic agent that will be effective and safe in this population.
This is a pilot, randomized, double-blinded, cross-over trial of pregabalin vs placebo for the treatment of RDEB associated neuropathic pain and itch. The study will run for 24 weeks and will have 4 separate phases with 6 overall visits: 1. Observation/wash out period (2 weeks); 2. ARM-1, ½ of the patients will receive pregabalin(A) and ½ the placebo (B) (10 weeks); 3. Wash out period (2 weeks) and 4. ARM-2 (patients who received placebo will receive pregabalin and pregabalin will receive placebo (10 weeks).
Patients will be recruited during the regular clinic visits or invited to participate via a letter followed by 2 phone calls.
- Screening/Wash out period #1 (Visit 0)to assess eligibility criteria and the background pain and itch level (2 weeks), as well as the effectiveness of patients' "standard pain/itch interventions". Throughout this phase and the rest of the study, patients will receive pain and itch medications, except those that interfere with the pregabalin (see exclusion criteria).
- Investigators will assess the eligibility criteria, including having moderate to severe pain (>4/10), the evidence of neuropathy using a thermal roller device ROLLTEMP2, Sometic, and a screening tool for neuropathic pain, the DN4 questionnaire 15 (Appendix 2).
- Investigators will collect basic demographic data, medication information and disease severity using iscorEB clinician portion, a valid outcome measure that evaluates the disease severity 16 and EBDASI 17 ( Data collection form: Baseline/Screening Form)
- Patients will be asked to report on their disease severity using iscorEB patient portion (all ages) that includes pain and itch domains and QOLEB 18 for those over 18 years of age (validated only for the adult population).
- Patients will be instructed how to collect daily assessments of pain and itching for 14 days before the next visit. For the overall pain intensity assessment, the investigators will use a 100mm VAS, where 0 is no pain and 10- the worst pain ever experienced. For itch assessments, the investigators will ask patients to score each day, before going to bed, the degree of itching experienced that day using a 100 mm horizontal VAS where 0 is no itch and 10 is the worst itch.19 The investigators chose the single item for its reliability, validity and responsiveness to change. These values will represent patient's baseline pain (AvePain-00) and itch (AveItch-00).
- ARM1 intervention study period (Visits 1 \& 2): ½ of the patients will receive the active intervention (Pregabalin) and ½ the placebo. This phase will be of 10 weeks duration and will consist of 4 weeks of escalating dose until the desired maximum, 4 weeks of active treatment and 2 weeks of titration down (see titration schedule in the Appendix 1)Patients will receive either active intervention (pregabalin) or placebo including instruction of how to administer them. Visit 1: (Week 2)
- Investigator will collect the data on pain and itching from the 2 weeks wash-out and will determine the average pain and itching of approximately 14 days prior to the study visit 1(AvePain-00, AveItch-00)
- Patients will be asked to report on their disease severity using iscorEB patient portion and QOLEB for those over 18 years of age.
- A team member will call patient twice a week during the escalation phase to inquire about adverse events
- Patients will be instructed to collect daily assessments of pain, and itch for 7 days before next visit (~from weeks 9-10). Visit 2: (Week 10)
- Patients will be instructed to contact investigator if experiencing any adverse events.
- Investigator will collect the data on pain and itching from approximately 7 days prior to visit 2 (~weeks 9-10) and will determine the average pain and itching (AvePain-02, AveItch-02)
- Patients will be asked to report on their disease severity using iscorEB patient portion and QOLEB for those over 18 years of age.
- Adverse events (see potential risks, DCF follow up, patient's diary)
- Patients will be instructed to collect daily assessments of pain, and itch for 7 days before next visit (~from weeks 13-14)
- Wash out period #2 (2 weeks) Visit 3 (Week 14)
- Investigator will collect the data on pain and itching and will determine the average pain and itching of approximately 7 days prior to the study visit 3 (AvePain-03, AveItch-03)
- Patients will be asked to report on their disease severity using iscorEB patient portion and QOLEB for those over 18 years of age.
- Investigator will collect adverse events (see potential risks, DCF follow up, patient's diary)
- Patients will be instructed to collect daily assessments of pain, and itch for 7 days before next visit (~from weeks 21-22)
- All study procedures at visit 3 will be similar to visit 1.
- ARM2 intervention study period (Visits 4 \& 5 (Week 22 and 24): patients randomized to placebo will receive pregabalin and those on placebo will get the pregabalin conducted similarly as in ARM1
- All study procedures at visit 4 will be similar to visit 2
- The outcome measures will be similar, but will be recorded as (AvePain-04, AveItch-04)
- Weaning will be similar to ARM1
- End of the Study visit: Visit 5 (Week 24) The outcome measures will be similar, but will be recorded as AvePain-05, AveItch-05)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- there two treatment periods in the study. All of the study participants will receive pregabalin treatment during one of these two 10-week treatment periods, and placebo - during the other one.
| Arm | Type | Receives |
|---|---|---|
| Pregabalin followed by placebo | Experimental | Drug: PregabalinThe study has a crossover design. Participants in this arm will receive pregabalin during the first study treatment period for ten weeks and placebo during their second ten-week treatment period . The dose will depend on the participant's weight and phase of treatment period. Each treatment period consists of 4 weeks of escalating dose until the desired maximum , 4 weeks of active treatment and 2 weeks of titrating down. |
| Placebo followed by Pregabalin | Experimental | Drug: PregabalinParticipants will receive placebo during the first treatment period of the study(10 weeks) followed by 10 weeks of pregabalin treatment . The dose will depend on the participant's weight and phase of the treatment period . Each treatment period consists of 3 phases: 4 weeks of escalating dose until the desired maximum, 4 weeks of active treatment and 2 weeks of titrating down. |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age: > 8 - 40 years (we selected this range due to lack of data in younger population and the difficulty in getting patient reported outcomes in younger patients)
- Diagnosis of RDEB (by a dermatologist and/or EB specialist and/or genetic confirmation)
- Evidence of neuropathy defined by: thermal sensory loss (determined by a thermal roller, ROLLTEMP2, Sometic, Sweden) 14 and > 4/10 score using a screening tool for neuropathic pain, the DN4 questionnaire 15
- Pain intensity of > 4/10 on a 0-10 VAS scale measured daily (reduced frequency is also acceptable) at night over 2 weeks
- Itch intensity of > 4/10 on a 0-10 VAS scale measures daily (reduced frequency is also acceptable) at night over 2 weeks
Key exclusion criteria (8 listed)
- Intolerance and/or allergy to Pregabalin or gabapentin
- Lactose intolerance (placebo capsules contain lactose)
- Pregabalin use within 2 weeks before study enrolment
- Ongoing treatment with gabapentin, amitriptyline, duloxetine, nortriptyline, other tricyclics or SNRIs
- Medical conditions that would be considered as contraindications for pregabalin treatment (ischemic heart disease, cardiac dysrhythmia, glaucoma, history of urinary retention)
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 |
|---|---|---|
| PregabalinAlso: PlaceboPregabalin /placebo capsules will be taken by mouth and will be prescribed for the study participants in the doses, depending on their weight and treatment phase: Participant < 25 kg at baseline will start with 50 mg per day, increasing the dose by 50 mg each week until their maximum dose 200 mg per day; Participants who are greater than or equal to 25 kg at baseline will start with 100 mg per day, increasing their dose by 50 mg each week until their target dose 300 mg per day is achieved. The study medication will be taken twice per day.The dose will be weaned down every 1-2 days by 25 mg in the last two weeks of each treatment period. | Drug | Placebo followed by Pregabalin, Pregabalin followed by placebo |
Primary outcome
Difference in the mean pain scores between pregabalin and placebo group: VAS
Time frame: 12 weeks
It will be measured as difference in the mean pain values pre- and post-intervention for each group using the Visual Analog Scale (VAS).It is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain ever). The patient is asked to mark their pain level on the line.The pain is scored using the VAS by measuring the distance in centimeters (0-10) from the "no pain" anchoring point.
8 secondary outcomes
Proportion of patients on pregabalin achieving a ≥75% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out
Time frame: 12 weeks
Proportion of patients on pregabalin achieving a ≥50% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out
Time frame: 12 weeks
Difference in the average pain score assessed using VAS between first and second treatment periods (period effect)
Time frame: 24 weeks
Proportion of patients on pregabalin achieving a ≥75% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out
Time frame: 24 weeks
Proportion of patients on pregabalin achieving a ≥50% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out
Time frame: 12 weerks
Difference in the average itch score as assessed using VAS between the first and the second treatment periods (period effect).
Time frame: 24 weeks
Changes in the Quality of Life in Epidermolysis Bullosa Questionnaire score(QOLEB) for patients >18yrs in the intervention versus placebo
Time frame: 24 weeks
Changes in iscorEB (instrument for scoring clinical outcomes for research of EB), patient portion score in the intervention versus placebo
Time frame: 24 weeks
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 22 Jan 2025.
- Derived from this study: PubMed 39441591Calvo M, Tejos-Bravo M, Passi-Solar A, Espinoza F, Fuentes I, Lara-Corrales I, Pope E. Pregabalin for Neuropathic Pain and Itch in Recessive Dystrophic Epidermolysis Bullosa: A Randomized Crossover Trial. JAMA Dermatol. 2024 Dec 1;160(12):1314-1319. doi: 10.1001/jamadermatol.2024.3767.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin in people with Pain, Neuropathic and Itch, run by The Hospital for Sick Children at 1 site in Canada.
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 6 inclusion and 8 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 22 Jan 2025. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Difference in the mean pain scores between pregabalin and placebo group: VAS (time frame: 12 weeks). 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 NCT03928093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.