Clinical Trials

HLB PHARMA

CTT-004

Clinical TrialsCTT-004

CTT-004

Taltirelin hydrate is an analog of TRH (Thyrotropin Releasing Hormone).TRH stimulates secretion of Thyroid Stimulating Hormone (TSH), which strengthens the effect of catecholamine, a sympathetic stimulator, leading to an increase in the secretion of neurotransmitters acetylcholine and dopamine, thereby improving ataxia. In addition, it increases serotonin secretion which helps improve judgment, memory, and depression disorders concurrent with ataxia.

What is spinocerebellar degeneration?

Spinocerebellar degeneration is a rare disease in which the cells making up the cerebellum die due to unknown mechanisms. Ataxia is the main symptom caused by spinocerebellar degeneration. As there has been no therapeutic agent with efficacy and safety proven through large-scale clinical trials, MEDIFORUM is currently carrying out clinical trial that aims to prove efficacy and safety at major domestic university hospitals, using the taltirelin hydrate.

Prevalence

Spinocerebellar degeneration is a rare disease. The prevalence rate of hereditary and non-hereditary ataxia nationwide stands at 8.29 out of 100,000 persons, out of whom the prevalence rate of hereditary ataxia is 4.99 out of 100,000 persons.


In both hereditary and non-hereditary groups, the prevalence rate is higher in men than in women. Hereditary ataxia is distributed widely throughout all age groups while non-hereditary ataxia occurs more often in people over age 50.

CTT-004 clinical overview

Study Title A multicenter, randomized, double-blind, placebo-controlled clinical trial to Evaluate and Compare the Safety and Efficacy of C-Trelin OD Tablet 5mg(Taltirelin Hydrate) in Patients with Ataxia Induced by Spinocerebellar Degeneration
Study Indication Ataxia Induced by spinocerebellar degeneration
Investigational Product C-Trelin OD Tablet 5mg(Taltirelin Hydrate)
Targeted subject No. 166participants(Clinical trials currently underway in 8 university hospitals)
Study Period 24 months after the date of IRB approval
Study Purpose Evaluation and establishment of the efficacy in patients with ataxia Induced by spinocerebellar degeneration