Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients With Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00041795

Enrollment

Registered

2002-07-19

Start date

2002-01-31

Completion date

Unknown

Last updated

2005-06-24

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

Conditions

Chemotherapy-Induced Peripheral Neuropathy, Peripheral Nervous System Diseases

Brief summary

This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.

Interventions

DRUGleteprinim potassium (Neotrofin)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patient must have diagnosis of cancer and be receiving or have received chemotherapy that has resulted in sensory or motor neuropathy. * Sensory or motor neuropathy must be \>/= grade 2 per Common Toxicity Criteria at baseline. * In patients diagnosed with multiple myeloma, grade 1 sensory or motor neuropathy is acceptable. * Patient must have normal hematological cell counts. * Patient must have a life expectancy of \>/= 3 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026