Evaluation of the efficacy of donepezil in the treatment of oxaliplatin-induced peripheral neuropathy

Evaluation of the efficacy of donepezil in the treatment of oxaliplatin-induced peripheral neuropathy: proof of concept study - DONEPEZOX

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005326-23-FR

Enrollment

Registered

2021-11-10

Start date

2022-01-24

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxaliplatine-induced peripheral neuropathy

Interventions

Trade Name: Donepezil Product Name: DONEPEZIL Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age =18 years, - Male / Female, - Patient who received adjuvant chemotherapy with oxaliplatin (FOLFOX/CAPOX/XELOX), for stage II/III CRC, - QLQ-CIPN20 sensory score =30 (equivalent to the NCI-CTCAE grade of neuropathy =2), - Diagnosis of OIPN treated or not by stable antineuropathic/analgesic treatment (opioids, pregabalin, gabapentin, duloxetine and other antidepressants or anticonvulsants) for at least 1 month, - Chemotherapy completed for at least 3 months, - Patients affiliated to the French national health insurance, - Written informed consent, - French language comprehension. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Rechute du cancer - Patient atteint d'une maladie chronique progressive (à l'exclusion de la neuropathie périphérique induite par l'oxaliplatine) - Autres types de neuropathies non liées à la chimiothérapie - ALAT / ASAT supérieur de plus de 3 fois les valeurs normales - Maladies cardiovasculaires graves (selon avis du clinicien), bradycardie (<55 bpm), troubles de la conduction cardiaque telle que maladie du sinus ou d'autres anomalies de la conduction supra-ventriculaire telles qu’un bloc sino-auriculaire ou auriculo-ventriculaire (évaluation par électrocardiogramme) - Antécédents de maladie ulcéreuse ou ulcère gastroduodénal actif - Asthme ou maladie pulmonaire obstructive - Allergie connue aux dérivés du donépézil ou de la pipéridine - Interactions médicamenteuses : Inhibiteurs du CYP3A4 (kétoconazole, itraconazole et érythromycine) ; inhibiteurs du CYP2D6 (fluoxétine) et inducteurs enzymatiques (rifampicine, phénytoïne, carbamazépine) - Intolérance connue au galactose, déficit connu en lactase de Lapp ou syndrome de malabsorption du glucose ou du galactose (maladies héréditaires rares) connu - Dépendance à l'alcool et/ou aux drogues connue - Troubles psychotiques connus, patient sous antipsychotiques - Autre cancer concomitant - Grossesse ou allaitement (contraception obligatoire) - Personne sous tutelle, sous curatelle, et sauvegarde de justice ou personne privée de liberté - Impossibilité de se soumettre au suivi médical de l’essai pour des raisons géographiques, sociales ou psychiques

Design outcomes

Primary

Measure	Time frame
Main Objective: assess the therapeutic efficacy of donepezil on the severity of oxaliplatin-induced peripheral neuropathy (responder rate using QLQ-CIPN20 sensory score, comparison before and after treatment) in CRC patient survivors who have received adjuvant oxaliplatin-based chemotherapy.;Secondary Objective: Efficacité du donépézil : comparaison avant vs après le traitement, et comparaison vs groupe placebo, pour l'amélioration de : -Symptômes neuropathiques (score QLQ-CIPN20 et taux de répondeur), -Grade de neuropathie périphérique (NCI-CTCAE), -Douleur neuropathique (NRS douleur + questionnaire DN4 interview) si présente (questionnaire NPSI), -Qualité de vie reliée à la santé (questionnaire QLQ-C30), -Ressenti du patient sur l’efficacité du traitement (PGIC), -Anxiété et dépression (questionnaire HADS), -Consommation d'analgésiques. Evaluation de la tolérance du traitement (type, intensité, fréquence des effets indésirables et taux de sortie en raison d'effets indésirables). ;Primary end point(s): The QLQ-CIPN20 questionnaire (EORTC) is a 20-item self-administered questionnaire that was developed specifically to assess patients' experience of symptoms and functional limitations due to their chemo-induced peripheral neuropathy (CIPN). The QLQ-CIPN20 is divided into 3 subscales: sensory, motor and vegetative and provides a comprehensive picture of the nature, frequency and severity of the CIPN. The sensitive subscale of the QLQ-CIPN20, which will be our main criterion of judgment, explores a wide range of symptoms, including paresthesia, dysesthesia, neuropathic pain and also numbness, which are the majority of CIPN symptoms. This questionnaire has been validated by two large international clinical trials.;Timepoint(s) of evaluation of this end point: 16 weeks	—

Measure

Time frame

Main Objective: assess the therapeutic efficacy of donepezil on the severity of oxaliplatin-induced peripheral neuropathy (responder rate using QLQ-CIPN20 sensory score, comparison before and after treatment) in CRC patient survivors who have received adjuvant oxaliplatin-based chemotherapy.;Secondary Objective: Efficacité du donépézil : comparaison avant vs après le traitement, et comparaison vs groupe placebo, pour l'amélioration de : -Symptômes neuropathiques (score QLQ-CIPN20 et taux de répondeur), -Grade de neuropathie périphérique (NCI-CTCAE), -Douleur neuropathique (NRS douleur + questionnaire DN4 interview) si présente (questionnaire NPSI), -Qualité de vie reliée à la santé (questionnaire QLQ-C30), -Ressenti du patient sur l’efficacité du traitement (PGIC), -Anxiété et dépression (questionnaire HADS), -Consommation d'analgésiques. Evaluation de la tolérance du traitement (type, intensité, fréquence des effets indésirables et taux de sortie en raison d'effets indésirables). ;Primary end point(s): The QLQ-CIPN20 questionnaire (EORTC) is a 20-item self-administered questionnaire that was developed specifically to assess patients' experience of symptoms and functional limitations due to their chemo-induced peripheral neuropathy (CIPN). The QLQ-CIPN20 is divided into 3 subscales: sensory, motor and vegetative and provides a comprehensive picture of the nature, frequency and severity of the CIPN. The sensitive subscale of the QLQ-CIPN20, which will be our main criterion of judgment, explores a wide range of symptoms, including paresthesia, dysesthesia, neuropathic pain and also numbness, which are the majority of CIPN symptoms. This questionnaire has been validated by two large international clinical trials.;Timepoint(s) of evaluation of this end point: 16 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - Peripheral neuropathy grade (NCI-CTCAE), - Neuropathic pain (11-point NRS pain + DN4 interview), if pain = 4/10 (NPSI questionnaire), - Health-related quality of life (QLQ-C30 questionnaire), - Patient global impression of change (PGIC), - Anxiety and depression (HADS questionnaire).;Timepoint(s) of evaluation of this end point: monthly	—

Countries

France

Contacts

Public ContactDRCI

CHU de Clermont-Ferrand

ggouby@chu-clermontferrand.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026