Information for Patients and Caregivers
Here, patients and caregivers will find information including standards of care, clinical progress, as well as links to other resources for the following medical conditions:
Our goal is to empower patients so they can make informed decisions about their treatment options and their future.
Raptor has Initiated a Phase 3 Clinical Trial of DR Cysteamine for the Potential Treatment of Cystinosis
Raptor has commenced a Phase 3 clinical trial of DR Cysteamine in cystinosis. Four US and five EU sites plan to participate in this clinical trial. The Phase 3 clinical trial is designed as a multi-center, randomized, crossover, outpatient study of the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of every 12-hour DR Cysteamine compared to immediate-release cysteamine bitartrate in cystinosis patients.
The primary endpoint of the study is the steady-state white blood cell (WBC) cystine levels of patients taking DR Cysteamine compared to immediate-release cysteamine bitartrate. Secondary endpoints are the safety and tolerability of DR Cysteamine and the comparability of steady-state PK of DR Cysteamine and immediate-release cysteamine bitartrate in cystinosis patients.
Raptor expects to initially enroll up to 30 patients. Patients who complete the nine-week clinical trial will be offered enrollment into Raptor’s long-term follow-on study. Two US sites are currently recruiting. Raptor anticipates that the Phase 3 clinical trial will be completed in December 2010.