Clinical Study on Acetyl-L-Carnitine

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Collaborators: Shanghai Changzheng Hospital; Shanghai Jiao Tong University School of Medicine
• Treatments: Acetylcarnitine

Criteria

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
• 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.