EVALUATION OF ACETYL -L-CARNITINE (ST 200) TO REDUCE INTENSITY OF TAXANES- OR PLATINUM-INDUCED SENSORY NEUROPATHY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000004-13-BE

Enrollment

172

Registered

2006-02-15

Start date

2005-09-16

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

Peripheral neurophaty in cancer patients previously treated with taxanes- or platinum-based chemotherapy MedDRA version: 7.0 Level: HLGT Classification code 10027655

Interventions

Product Name: Acetyl-L-carnitine Product Code: ST 200 Pharmaceutical Form: Powder for oral solution INN or Proposed INN: acetyl-L-carnitine CAS Number: 5080-50-2 Current Sponsor code: ST 200 Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and female age >/= 18 years; - Written informed consent; - Karnofsky > 60; - Life expectancy >/= 6 months; - Adequate organ functions defined as follows: - absolute neutrophil count >/= 1.0 *10^9 L - platelet count >/= 75.0 *10^9 L - serum creatinine level =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pre-existing neuropathies of different origin than those considered in this trial; - diabetes mellitus, insulin-dependent; - symptomatic brain metastases; - leptomeningeal involvement; - significant infective illness or active inflamed focus; - concomitant therapy with other neuroprotective agents (for details, see section 5.5 of the protocol); - any previous use of neuro-protectant drugs (such as sodium thiosulphate, glutathione, amifostine, gabapentin, lamotrigine, glutamic acid, ACTH analogues, neuronal growth factors, Vitamin E) if performed from the last chemotherapy administration, onwards; - any neurotoxic chemotherapy since one month prior to baseline; - predictable lack of patient’s co-operation; - pregnancy, nursing, or women of childbearing potential not using an effective method of birth control; - concomitant use of both platinum and taxane in the same line chemotherapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to evaluate the efficacy of ALC in reducing the intensity of taxanes- or platinum-induced sensory neuropathy in cancer patients.;Secondary Objective: The secondary objectives are to evaluate: - Motor item of NCI-CTC version 3.0 - ulnar, sural and common peroneal nerve conduction velocity (NCV); - symptoms/signs of peripheral damage; - vibration perception threshold; - total neuropathy score, TNS; - plasma NGF level. ;Primary end point(s): The sensory item of NCI-CTC version 3.0 December 12th, 2003 will be the primary endpoint.	—

Measure

Time frame

Main Objective: The main objective of the study is to evaluate the efficacy of ALC in reducing the intensity of taxanes- or platinum-induced sensory neuropathy in cancer patients.;Secondary Objective: The secondary objectives are to evaluate: - Motor item of NCI-CTC version 3.0 - ulnar, sural and common peroneal nerve conduction velocity (NCV); - symptoms/signs of peripheral damage; - vibration perception threshold; - total neuropathy score, TNS; - plasma NGF level. ;Primary end point(s): The sensory item of NCI-CTC version 3.0 December 12th, 2003 will be the primary endpoint.

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Countries

Belgium, Italy

Outcome results

None listed

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