A Clinical Research Study may evaluate whether an
investigational study medication is effective in treating a
particular condition and checks for any unwanted side effects. In
order for an investigational study medication to be approved for use
in the general public, it must first be rigorously assessed in
several clinical research studies. Even when a medication is already
approved for the treatment of particular condition, further clinical
research is needed before it can be approved for use in a different
manner( for example, if it is going to be administered differently
or if it is to be used as a standalone therapy instead of in
combination with other medications.)
Clinical research studies are performed according to strict
health authority guidelines. These guidelines ensure that patient’s
right is protected in the study, while still allowing valuable
information about the investigational study drug to be collected.
Clinical Research is conducted in four phases. Each phase of
clinical research has a different purpose and helps scientists
answer different questions:
PHASEI: Researchers test the investigational study drug in
healthy volunteers to study how the study drug behaves in the human
body, the study drug’s safety, the safe dosage range for patients
and potential side effects that could occur.
PHASEII: Volunteers with the specific target condition
participate and further help test the safety of the investigational
study drug and also begin to test the effectiveness of the study
drug.
PHASEIII: An even larger number of volunteers is used to help
further study the effectiveness, monitor the safety, check for side
effects and sometimes compare the study drug to other medications
that are used to treat the same condition.
PHASE IV: Phase 4 studies are conducted after an
investigational study has been approved and is available for
prescription to the public. The purpose of this phase is to study
the safety and effectiveness of the study drug in a larger, more
diverse population over a longer period of time.
Neurology NDX Lab has performed numerous clinical studies for
varieties of neurological disease such as: Parkinson disease,
Alzheimer’s disease, Migraines, seizures and MS.
If you need further information please contact the office at
205-664-2967.
Currently we are screening patients for 2 clinical studies. Both
are phase lll Studies.
In both studies are seizure studies that we screen patients with
partial onset seizures with or without secondary generalization.
If you know someone with epilepsy who would like to know more
about these studies he/she can contact our office and ask for Mary
Mostaghimi Primary Study Coordinator. Our study line phone number is
205-664-2377. |