Known also as disseminated sclerosis. Multiple Sclerosis is a chronic disease that commonly appears between the ages of 20-40. There are more than 120,000 patients with Multiple Sclerosis in Britain. Every year approximately 5,000 people are affected by MS and the rate is increasing, especially in women. The disease affects more than twice the number of women than men.
The cause of the disease is not exactly known but is the result of a combination of hereditary factors combined with environmental factors. It is possible that it could be a virus that, combined with factors of the immune system, triggers the disease. Vitamin D and sunlight help protect against the disease.
The first symptoms of Multiple Sclerosis are sensory disturbances in the arms and/or legs, reduced strength in the arms or legs, visual impairment and eye pain, dizziness, balance disorders and urinary problems.
In its typical form, the disease is characterized by repeated attacks from different parts of the central nervous system (brain and spinal cord). It is thus said that the symptoms are spread (disseminated) in time and place. The individual attacks can have a wide variety of symptoms as they come from different parts of the nervous system.
Most patients have an ataxial course with new attacks occurring at varying intervals with varying degrees of symptoms. The condition tends to be stable between attacks. After several years, typically 10-12, most MS attacks develop into the secondary progressive phase in which the person, independently of the attacks, has progressive symptoms.
In a smaller portion of patients, the disease starts as a slowly increasing paralysis of the legs without actual attacks and is known as Primary Progressive Multiple Sclerosis.
The condition of more advanced Multiple Sclerosis is characterized by symptoms from different areas of the central nervous system: visual impairment, double vision, spastic paralysis of the arms and/or legs, sensory disturbances, poor balance, urinary disturbances, constipation, sexual problems, pain, fatigue and memory and concentration problems.
It starts with the first line researchers, who can be doctors, pharmacists or biochemists. They can be employed by either the pharmaceutical industry or by independent research institutes. The researchers experiment with gene therapy, new active substances and new technology. Initial testing is conducted on mice or rats in the lab to document its effects.
If the results of the animal testing prove successful, the next step is testing the drug on human subjects in clinical trials, which always take place in the hospitals and clinics where the patients are. It is here, in the hospitals and clinics, that responsibility for the next step of research is granted to the study nurses and doctors. These roles are defined as an investigator. The initial researchers are not allowed to be involved with the clinical trials to ensure they cannot affect the outcome of the clinical trials.
Before a clinical trial can start, it must be approved by the health authorities in every country where the trial takes place. The medical trial, in the form of a protocol, describes in detail the purpose of the study as well as how it is to be conducted. In addition, the Ethics Committee in all participating countries must approve the trial after carefully considering the ethical protection of the participants.
The clinical trials are conducted in four phases – read more here. It starts with phase 1, with a small number of participants and proceeds to phase 4, with several thousand participants.
Study to evaluate VSN16R for treatment of spasticity in subjects with Multiple Sclerosis.
Sponsor: Canbex Therapeutics