CLINICAL RESEARCH STUDY


Doctor M. Mostaghimi

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 patientís 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 drugís 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, Alzheimerís 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.