ALS Ice Bucket Challenge Progress
Duke ALS Clinic, Durham
For more information, please send an email to alsresearch@duke.edu
Wake Forest Baptist Health ALS Center, Winston-Salem
For more information, please contact Mozhdeh Marandi at 336-713-8577 or email mmarandi@wakehealth.edu
Atrium Health Neurosciences Institute Neurology, Charlotte
For more information, please contact Allison Newell-Sturdivant at 704-355-5285 or Allison.Newell-Sturdivant@atriumhealth.org
UNC ALS Clinic, Chapel Hill
For more information, please contact Manisha Chopra at 919-843-7857 or email chopram@neurology.unc.edu
Clinical Trial Phases Information:
https://research.alsnc.org/
• Pilot trial: Is a small study that may include testing of an approved drug for another indication that is being tested in ALS patients to determine safety and tolerability or a study to identify relevant biomarkers.
• Phase I: Testing looks at the safety of a candidate treatment, often in twenty or fewer people. Participants are examined for any adverse reactions or side effects. If any appear that are judged to be too dangerous, testing is halted, and the drug will not advance any further in the clinical trials process.
• Phase II: Testing attempts to determine the optimal dose, route (by mouth, by injection, etc.) and timing of doses of the candidate treatment. Information about a drug’s ability to help in the disease may be obtained in the course of phase II testing, but such findings are not able to reliably predict a candidate’s effect. Usually for ALS less than a hundred patients are involved.
• Phase III: The therapeutic effect of the candidate is specifically sought in phase III testing. This is the stage of testing that enrolls enough patients to allow a statistical judgment that a treatment is effective. Phase III trials for ALS usually require hundreds of participants. Large numbers are required due to the diversity of the ALS population. No person with ALS is the same and notably, disease progression from one individual to another is highly variable.
