Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

African Trypanosomiasis Clinical Trial

Official title: Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Status Completed

Clinical Trial Summary

Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs that are easily administered and have low toxicity, and might thus be used as tools to support disease control.

This study aims to compare the safety and efficacy of DB289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the Democratic Republic of Congo Ministries of Health.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• African Trypanosomiasis
• Trypanosomiasis
• Trypanosomiasis, African

• NCT number: NCT00803933
• Study type: Interventional
• Source: Immtech Pharmaceuticals, Inc
• Status: Completed
• Phase: Phase 2
• Start date: February 2003
• Completion date: June 2005