PILOT STUDY OF OXCARBAZEPINE TOLEP ACTIVITY IN ANTICANCER DRUGS NEUROPHATIES - TOLMAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006669-17-IT

Enrollment

Registered

2007-02-15

Start date

2006-12-27

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Neuropathic patients MedDRA version: 6.1 Level: PT Classification code 10034620

Interventions

Trade Name: TOLEP Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria age 25-60 yrs treated with cisplatin or taxanes end of treatment since 2 weeks at least at least grade 1 neuropathy according to WHO scale life expectancy of 1 year at least 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: patients who, before treatment, show SNC or SNP lesions excepting paraneoplastic neuropathy

Design outcomes

Primary

Measure	Time frame
Main Objective: EVALUATION OF OXCARBAZEPINE 900 MG/DIE ACTIVITY ON NEUROPHATY INDUCED BY TAXANES AND CISPLATIN ACCORDING TO WHO SCALE;Secondary Objective: EVALUATION OF OXCARBAZEPINE 900 MG/DIE ACTIVITY ON NEUROPATHY INDUCED BY TAXANES AND CISPLATIN ON SUBJECTIVE SYMPTHOMS PARESTESIES, DISESTESIES, SUBJECTIVE HYPOESTHESIE NEUROLOGIC SIGNS DEEP REFLEXES, ATAXIA, ETC. ;Primary end point(s): Evaluation of patient number who after a 30 day treatment with oxcarbazepine show a decrease of 1 grade intensity of WHO scale for neuropathy	—

Measure

Time frame

Main Objective: EVALUATION OF OXCARBAZEPINE 900 MG/DIE ACTIVITY ON NEUROPHATY INDUCED BY TAXANES AND CISPLATIN ACCORDING TO WHO SCALE;Secondary Objective: EVALUATION OF OXCARBAZEPINE 900 MG/DIE ACTIVITY ON NEUROPATHY INDUCED BY TAXANES AND CISPLATIN ON SUBJECTIVE SYMPTHOMS PARESTESIES, DISESTESIES, SUBJECTIVE HYPOESTHESIE NEUROLOGIC SIGNS DEEP REFLEXES, ATAXIA, ETC. ;Primary end point(s): Evaluation of patient number who after a 30 day treatment with oxcarbazepine show a decrease of 1 grade intensity of WHO scale for neuropathy

—

Countries

Italy

Outcome results

None listed

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