Santhera Starts Phase III Trial for Friedreich's Ataxia Treatment
Posted on: Tuesday, 2 October 2007, 12:00 CDT
Swiss specialty pharmaceutical company Santhera has reached an agreement with the FDA under the special protocol assessment procedure relating to the Phase III clinical trial to evaluate idebenone for the treatment of Friedreich's ataxia.
The trial with SNT-MC17, named IONIA (idebenone effects on neurological ICARS assessments), is a double-blind, randomized, placebo-controlled study of six months duration investigating the efficacy of two doses of SNT-MC17 compared to placebo. The primary endpoint of IONIA will be a neurological endpoint, measured by the international cooperative ataxia rating scale (ICARS), comparing the change in the ICARS for each of the treatment groups with placebo over the 24 week study period. The study will also investigate additional neurological endpoints as well as activities of daily living parameters and cardiac measures.
The IONIA study will recruit a minimum of 51 ambulatory Friedreich's ataxia (FRDA) patients between the ages of 8 and 17 years and will be conducted at two clinical centers in the US - the Children's Hospital of Philadelphia and the School of Medicine of the University of California, Los Angeles. Patient recruitment is expected to start soon.
Klaus Schollmeier, CEO, said: "With the offering of an extension study and FDA's fast-track designation granted, we now believe that we can successfully complete the development of SNT-MC17 for FRDA in the US during the course of 2009. SNT-MC17 has a good chance to become the first pharmaceutical product approved in the US for this devastating disease."
Source: Datamonitor
Related Articles
- Why One Way Of Learning Is Better Than Another
- Sub-Analysis of Phase III Suggests Long-Term Therapy May Improve Physical and Social Functioning In CIDP Patients
- Epilepsy Drug Adds Birth Risk
- Alvine Initiates Phase I Trial for Celiac Disease Treatment
- New Study Results Show Asenapine More Effective Than Placebo in the Treatment of Acute Schizophrenia
- Santhera Announces Start of US Phase III Clinical Trial With SNT-MC17 in Friedreich's Ataxia and Provides Details on Study Design
- Can-Fite: Pre-Clinical Studies Demonstrate That the Excipients Used in the Placebo and CF101 Drug Enhanced the Anti-Inflammatory Effect of Methotrexate (MTX)
- Restless Legs Can Heighten Blood Pressure
- Aeolus Pharmaceuticals, Inc. Announces Publication of Results of AEOL 10150 Studies in Annals of Neurology
- Ataxia, Autism, and the Cerebellum: a Clinical Study of 32 Individuals With Congenital Ataxia
 |
 |
User Comments (0)
RSS Feeds