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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2008-001218-26 | |||
| TRO19622 CL E Q 1204-1 | Other Identifier | trophos id |
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The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.
Chemotherapy Induced Peripheral Neuropathy represents a frequent and invalidating side effect that requires treatment. Current treatment options are multiple, but none have yet demonstrated efficacy in double-blind clinical trials .
This study will provide information useful to determine the potential of TRO19622 to relieve both pain and dysesthesia which are the most common symptoms experienced by patients with peripheral neuropathy following taxane chemotherapy.
At the start of the study, patients will be randomized to one of two groups : TRO19622 (330 mg QD or placebo once a day).
Each treatment will be administered for 6 weeks. Additionally, patients will have the option to continue treatment for another 6 weeks duration.
Treatment will be administered under double-blind conditions. The product under evaluation will be administered to patients receiving the standard of care for CIPN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRO19622 | Experimental | 2 capsules of TRO19622 (330mg) once day with the noon meal |
|
| Control | Placebo Comparator | 2 capsules of placebo once day with the noon meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olesoxime (TRO19622) | Drug | 2 capsules of TRO19622 (330 mg) once day with the noon meal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be the measure of the percentage of responders defined as patients with a minimum decrease of 50 % of their maximum neuropathic pain dimension (either pain or dysesthesia) present at baseline. | The mean pain score during the last 7 days of the treatment period will be compared to the mean score of the last 7 days of the screening score period. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment with respect to placebo of the effect of TRO19622 on Neuropathic Pain Inventory Score(total and by dimension) | Screening visit; V0; V1; V2; V3; V4 ; V5 | |
| Assessment with respect to placebo of the effect of TRO19622 on Short- Form BPI | Screening visit; V0; V1; V2; V3; V4 ; V5 |
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Inclusion Criteria:
The following inclusion criteria should be ascertained at the baseline visit:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Krakowski, MD | Centre Alexis Vautrin / Département d'Oncologie Médicale/ Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Versailles Hôpital André Mignot Service d'Hématologie-Oncologie | Le Chesnay | 78157 | France | |||
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| ID | Term |
|---|---|
| C522838 | olesoxime |
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| Placebo Control |
| Drug |
Placebo Control 2 capsules once day with the noon meal |
|
| Assessment with respect to placebo of the effect of TRO19622 on Quality of life questionnaire (CIPN 20) | V0; V3; V5 |
| Assessment with respect to placebo of the effect of TRO19622 on Dysgueusia questionnaire | V0; V3; V5 |
| Assessment with respect to placebo of the effect of TRO19622 on Quantitative Sensory Testing | V0; V3; V5 |
| Assessment with respect to placebo of the effect of TRO19622 on ENMG | V0; V3; V5 |
| Assessment with respect to placebo of the effect of TRO19622 on the use of rescue medication | Screening visit; V0; V1; V2; V3; V4 ; V5 |
| Assessment with respect to placebo of the effect of TRO19622 on safety profile | Screening visit; V0; V1; V2; V3; V4 ; V5 |
| Assessment with respect to placebo of the effect of TRO19622 on Global Impression of change as assessed by Investigator | V1; V2; V3; V4; V5 |
| Assessment with respect to placebo of the effect of TRO19622 on Global Impression of change as assessed by patient | V1; V2; V3; V4; V5 |
| Assessment with respect to placebo of the effect of TRO19622 on Hospital Anxiety and Depression scale | V0;V3;V5 |
| Centre Oscar Lambret Département de Sénologie |
| Lille |
| 59000 |
| France |
| Centre Léon Bérard Département de Soins de Support | Lyon | 69373 | France |
| C.R.L.C Val d'Aurelle Service d'Oncologie Médicale | Montpellier | 34298 | France |
| Centre Alexis Vautrin | Nancy | 54511 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hôpital Nord CHU Saint Etienne Centre de la douleur | Saint-Etienne | 42055 | France |
| Hôpital Privé de l'Ouest Parisien Service d'Oncologie | Trappes | 78190 | France |