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Chronic pruritus affects 10-20% of the population and causes a major reduction in quality of life, comparable to pain, with significant psychological, social, and functional consequences. Current treatments are often insufficient, highlighting the urgent need for new therapeutic options.
Recent advances in the pathophysiology of itch have shown the involvement of the endocannabinoid system (CB1, CB2, and TRPV1 receptors) in modulating itch signal transmission and cutaneous inflammation. Cannabinoids, particularly the balanced CBD:THC combination, appear promising as they provide both central and peripheral antipruritic effects, while CBD helps mitigate the psychotropic side effects of THC.
Preclinical studies and limited clinical data suggest efficacy across various forms of pruritus (dermatological, uremic, cholestatic), though robust controlled trials are still lacking. Evidence from nabiximols (1:1 CBD:THC spray) in other conditions such as neuropathic pain and spasticity further supports the rationale for this approach.
Therefore, sublingual LGP THC25:CBD25 oil has been selected for its balanced ratio, simple administration route, and expected tolerability, to evaluate its efficacy and safety in the treatment of chronic pruritus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabis oil | Experimental | CBD:THC oil 50mg/mL arm : An auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say then only 0.1 per day , up to 1 ml/day maximum. If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised. After initial titration, the dose will then be maintained for 4 consecutive weeks. |
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| PLACEBO | Placebo Comparator | Placebo arm : An auto-titration phase will take place during the first 14 days of treatment with the same modalities as experimental group If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised. After initial titration, the dose will then be maintained for 4 consecutive weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis oil | Drug | Patients in this arm will have to take Cannabis oil (50mg/mL) twice a day with the daily dose estimated during auto titration phase (from W0 to W2) |
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| Measure | Description | Time Frame |
|---|---|---|
| WI-NRS change | Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6. | Week 0 |
| WI-NRS change | Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| WI-NRS change from W0 to W2 | - Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2 | Week 0 |
| WI-NRS change from W0 to W2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent MISERY, PU-PH | Contact | laurent.misery@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | 49000 | France |
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A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study
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| Placebo | Drug | Patients in this arm will have to take Placebo oil twice a day with the daily dose estimated during auto titration phase (from W0 to W2) |
|
- Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2 |
| Week 2 |
| WI-NRS change from W2 to W6 | Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from week 2 to week 6. | Week 2 |
| WI-NRS change from W2 to W6 | Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from week 2 to week 6. | Week 6 |
| ItchyQoL change from W0 to W2 | - Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) | Week 0 |
| ItchyQoL change from W0 to W2 | - Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) | Week 2 |
| ItchyQoL change from W2 to W6 | - Percent change in ItchyQoL score from Week 2 visit to week 6 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) | Week 2 |
| ItchyQoL change from W2 to W6 | - Change in ItchyQoL score from Week 2 visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time) | Week 6 |
| Chronic Itch Burden Scale change from W0 to W2 | - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching) | Week 0 |
| Chronic Itch Burden Scale change from W0 to W2 | - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching) | Week 2 |
| Chronic Itch Burden Scale change from W2 to W6 | - Percent change in Chronic Itch Burden Scale - 10 from Week 2 visit to week 6 (10 questions rated from "Not at all" to "Very much" on patient itching) | Week 2 |
| Chronic Itch Burden Scale change from W2 to W6 | - Percent change in Chronic Itch Burden Scale - 10 from Week 2 visit to week 6 (10 questions rated from "Not at all" to "Very much" on patient itching) | Week 6 |
| Treatment adverse events | - Incidence and severity of treatment-emergent adverse events. | Week 0 |
| Treatment adverse events | - Incidence and severity of treatment-emergent adverse events. | Week 2 |
| Treatment adverse events | - Incidence and severity of treatment-emergent adverse events. | Week 4 |
| Treatment adverse events | - Incidence and severity of treatment-emergent adverse events. | Week 6 |
| Treatment adverse events | - Incidence and severity of treatment-emergent adverse events. | Week 8 |
| Treatment Observance Rate | - Number of observant patients (YES/NO) in both arms: Observance (defined as YES) is considered as taking at least one dose of treatment per day over the W0 - W6 period. | Week 6 |
| CHD Vendée | La Roche-sur-Yon | France | 85925 | France |
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| Groupe Hospitalier La Rochelle | La Rochelle | France | 17300 | France |
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| CHU de Nantes | Nantes | France | 44093 | France |
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| CHU de Poitiers | Poitiers | France | 86000 | France |
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| CHRU de Tours | Tours | France | 37044 | France |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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