Apologies if already posted ... Also note to admin: I wasn't sure if this is the right forum section so feel free to move to Other Health or wherever you see fit. The trial is for fibro but chronic fatigue as a symptom that is helped by this treatment is mentioned a lot ...
http://www.as.ua.edu/home/professor-surgeon-team-headed-to-third-phase-clinical-trials/
Carol Duffy is proof that changing your mind is not only acceptable, but that doing so can often lead to something momentous. Duffy, an associate professor in the Department of Biological Sciences, is headed somewhere that very few faculty members have the chance to go – to a third phase clinical trial for a drug combination that has shown promising results to treat not only one, but several painful and debilitating illnesses.
....
Their biggest challenge, as Duffy saw it, would be to show that the virus is causing the symptoms. Chronic gastrointestinal conditions such as peptic ulcers have been considered bacterial infections for decades and are often treated with antibiotics. Fibromyalgia, on the other end of the spectrum, has been thought to originate in the nerves and muscles, causing pain. Duffy needed to show that these patients’ symptoms – things such as extreme pain, sleep disturbance, exhaustion, and headaches, among others – were being caused by an immune system response to a virus.
“I told him I wanted to see the tissue because nobody is going to believe us unless we show that the virus is there,” she said.
... By May 2013, they had raised enough funds to start a small-scale, second phase trial, which they finished in January. By March, they had raised a total of $5 million. Despite the trial’s small scale – they enrolled a little more than 140 people – Duffy says the results were incredible. They were so promising, in fact, that the duo has continued to convince key players in the field to join their cause.
... As Duffy and Pridgen look to conduct a series of larger-scale, third phase clinical trials – a cost they’ve estimated to be $50-$100 million – they are searching for the quickest, most cost effective way to get their treatment to market. ... “Even with the smaller dose that we used in the phase two trial, we had great results,” Duffy said. “But if the FDA is going to approve our drug combination, we want it to be at the dose that’s going to help people the most.”
http://www.as.ua.edu/home/professor-surgeon-team-headed-to-third-phase-clinical-trials/
Carol Duffy is proof that changing your mind is not only acceptable, but that doing so can often lead to something momentous. Duffy, an associate professor in the Department of Biological Sciences, is headed somewhere that very few faculty members have the chance to go – to a third phase clinical trial for a drug combination that has shown promising results to treat not only one, but several painful and debilitating illnesses.
....
Their biggest challenge, as Duffy saw it, would be to show that the virus is causing the symptoms. Chronic gastrointestinal conditions such as peptic ulcers have been considered bacterial infections for decades and are often treated with antibiotics. Fibromyalgia, on the other end of the spectrum, has been thought to originate in the nerves and muscles, causing pain. Duffy needed to show that these patients’ symptoms – things such as extreme pain, sleep disturbance, exhaustion, and headaches, among others – were being caused by an immune system response to a virus.
“I told him I wanted to see the tissue because nobody is going to believe us unless we show that the virus is there,” she said.
... By May 2013, they had raised enough funds to start a small-scale, second phase trial, which they finished in January. By March, they had raised a total of $5 million. Despite the trial’s small scale – they enrolled a little more than 140 people – Duffy says the results were incredible. They were so promising, in fact, that the duo has continued to convince key players in the field to join their cause.
... As Duffy and Pridgen look to conduct a series of larger-scale, third phase clinical trials – a cost they’ve estimated to be $50-$100 million – they are searching for the quickest, most cost effective way to get their treatment to market. ... “Even with the smaller dose that we used in the phase two trial, we had great results,” Duffy said. “But if the FDA is going to approve our drug combination, we want it to be at the dose that’s going to help people the most.”