Clinical Study on Acetyl-L-Carnitine

Lee's Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Peripheral Sensory Neuropathy

Treatments: Drug: Placebo; Drug: Acetylcarnitine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01526564

ZHAOKE-2007L03540

Details and patient eligibility

About

Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonomic nervous dysfunction.

Full description

This multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is to observe the efficacy and safety of the Acetyl-L-Carnitine Hydrochloride enteric-coated tablets in treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.

Enrollment: 239 patients

Sex: All

Ages: 18 weeks to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients had signed the Informed Consent Form
• Male or Female
• Age 18-75 years old
• Patients who have treated with Taxoids, Satraplatin and Vincristine; The peripheral sensory neuropathy grading after chemotherapy was >/=grade 3 or grade 2 lasting for one month
• The course of neuropathy was </=6 months
• No need to continue chemotherapy according to the condition nor refusing chemotherapy
• At least one of the neuroelectrophysiological examine results were abnormal
• Physical Condition Score (KPS) >/=60
• Anticipated lifetime>/=60.

Exclusion criteria

• Patients whose peripheral sensory neuropathy was induced by medicines except of the Taxoids, Satraplatin and vincristine anti-cancer chemotherapeutics
• Diabetics
• Peripheral sensory neuropathy was induced by Vitamin deficiency, infections, trauma, toxicosis, compression, and ischemia
• Peripheral sensory neurologic dysfunction that induced by lesions of central nervous system; hereditary neuropathy
• Patients who have treated by other medicines for peripheral sensory neuropathy in 30 days
• Patients had treated by other clinical trial medicines or participated into other trials in 30 days
• Patients had active infections
• Any clinical problems out of control
• Women in pregnancy and lactation, Subjects with no compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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239 participants in 2 patient groups, including a placebo group

ALC

Active Comparator group

Description:

ALC

Treatment:

Drug: Acetylcarnitine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo