2 posts tagged “@ALSUntangled”

PatientsLikeMe Launches Virtual Trial for ALS Patients

Posted October 25th, 2016 by

Study With Major Academic Medical Center to Evaluate the Potential of the Soy Peptide Lunasin to Reverse ALS Symptoms


DURHAM, N.C., October 25, 2016—PatientsLikeMe and The Duke ALS Clinic have just completed enrollment in a virtual trial designed to test whether Lunasin, a peptide found in soy and some cereal grains, is helpful or harmful to patients living with amyotrophic lateral sclerosis (ALS). The Lunasin Virtual Trial is the first study of the supplement in ALS patients and follows a review analyzing its potential to reverse ALS in ALSUntangled, a website for clinicians, patients and researchers to explore alternative treatments.

Duke ALS Clinic Director and ALSUntangled Founder Richard Bedlack, MD, said he first heard about Lunasin’s potential from Mike McDuff, an ALS patient who took the supplement and experienced dramatic improvements in speech, swallowing and limb strength.

“I reviewed Mike’s records and reports, and both his diagnosis and his improvements appeared real,” Bedlack said. “Of course, Mike might have an ALS mimic we don’t know how to test for, or his body may have found a way to beat ALS independent of treatment. But there is one more possibility: his Lunasin regimen might have actually worked. I was compelled to design a study to treat other ALS patients with the same regimen to test if anyone else improves.”

As part of the trial, 50 participants will make three in-person visits to the Duke ALS clinic to measure the supplement’s impact over the course of the year-long study. They will also complete virtual check-ins as members of PatientsLikeMe every 30 days to update their weight, complete an evaluation of their Lunasin regimen, and complete the ALS Functional Rating Scale (Revised, ALSFRS-R), a widely-used patient-reported outcome developed by PatientsLikeMe that allows patients to see their disease progression visually and in context.

Bedlack said the study’s design is patient-centric and eliminates many of the frustrations patients say are inherent in traditional clinical trials. The design also likely contributed to what Bedlack calls the fastest enrollment of any trial in ALS history: the virtual trial took just over five months to fill.

“There are no placebos, and we made the inclusion criteria very broad so that even ALS patients who can’t qualify for other studies due to their long disease duration or use of a ventilator can qualify,” Bedlack said. “We’re also limiting the burden on the participants by helping them check in online from the comfort of home. And we’ve already published the protocol on our ALS Reversals website. We’re taking a completely open approach so that anyone, anywhere, can see the details of what we’re testing and learn more about whether this is helpful, harmful, or does nothing at all. I think all of these factors made the trial very attractive to ALS patients.”

PatientsLikeMe began as a website for people living with ALS to openly share their experiences with each other and study alternative and off-label treatments. Vice President of Innovation Paul Wicks, PhD, said the company’s research focus gave ALS patients a science-based platform to monitor themselves, get ideas from other patients, and play a more active role in their own healthcare. That focus has also helped the company produce more than 30 published research studies on the condition, including a 2011 observational study in Nature Biotechnology that refuted the results of a 2008 clinical trial on the efficacy of lithium carbonate on ALS. More recently the company has worked with Bedlack to study the frequency of ALS plateaus and reversals. Findings from that study were recently published online and in the March 2016 print edition of the journal Neurology.

Anyone taking Lunasin outside of the Lunasin Virtual Trial is invited to separately track their experiences on PatientsLikeMe at www.patientslikeme.com.

ALS is a degenerative disorder affecting upper motor neurons in the brain and lower motor neurons in the brain stem and spinal cord. Symptoms include progressive weakness, atrophy, fasciculation, dysphagia, and eventual paralysis of respiratory function.

Study Design Methodology

The Lunasin Virtual Trial is a 12-month, widely inclusive, largely virtual, single-center, open-label pilot trial utilizing a historical control group. Participants will be asked to sign in or register for an account on www.patientslikeme.com with the help of the study coordinator and will be given a welcome packet that includes a one sheet description of the study, a checkup checklist, and the first month of a total 12-month supply of Lunasin. User IDs associated with participants’ PatientsLikeMe account will be recorded by the study coordinator and shared with study staff at PatientsLikeMe. After the initial in-clinic visit, participants will be asked to enter the following data online: weight, Lunasin study drug regimen evaluation, and their ALSFRS-R score.

About PatientsLikeMe

PatientsLikeMe is a patient network that improves lives and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. In the process, they generate data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers, and nonprofits develop more effective products, services, and care. With more than 400,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 80 research studies. Visit us at www.patientslikeme.com or follow us via our blog, Twitter or Facebook.

Contact                                                                                                Margot Carlson Delogne
PatientsLikeMe
mcdelogne@patientslikeme.com
+1.781.492.1039


Share Your Data to Untangle ALS!

Posted January 24th, 2011 by

Our ALS Community recently broke the 5,000-member mark, making it the largest of its kind in the world as well as the ideal platform for expedited research.  And that’s just what we’re working on.

Since the community’s launch in 2006, we’ve conducted a number of research studies, both internally and in collaboration with leaders in the field.  The goal is to turn up the answers that patients like you are seeking.  For example, can lithium slow the progression of ALS?  Or does limb dominance (aka “handedness”) correlate with ALS symptom onset?  Check out the findings from our patient-led Lithium and ALS Study as well as our work with the University of Oxford on handedness.

We also like to think of the dynamic, up-to-the-minute reports on our site, such as our treatment reports and symptom reports, as another form of “research.”   Every day, patients just like you contribute to these reports by sharing your real-world data, including what symptoms you’re experiencing, how you’re treating your condition and how well your treatments are working for you.

alsuNow, the data you share is helping even more people.  Through an exciting new partnership with ALS Untangled (ALSU), we are helping to take the data you share straight to the scientific literature – and at record speed.  ALSU is an international consortium of clinicians and researchers seeking to investigate alternative and off-label therapies for ALS using the Internet, namely Twitter, Ning and PatientsLikeMe.  Through these modern methods, they aim to provide “timely, accurate and scientifically valid analysis of alternative and off-label therapies.”

As they wrote in their mission statement, there are three phases to their cutting-edge approach:

  1. In the learning phase, they use their Twitter feed (@ALSUntangled) to collect ideas for potential therapies to investigate from patients just like you.  (Got something you want investigated?  Suggest it today!)
  2. Then, in the discussion phase, they import these targeted therapies into a closed Ning group and gather information on them from the consortium, including PatientsLikeMe.
  3. Finally, in the public release phase, they publish their findings as open-access articles in the prestigious journal Amyotrophic Lateral Sclerosis.  That means patients like you, caregivers, clinicians and researchers all over the world can read these reports in entirety for free.

Our first collaboration with ALSU focused on the use of Low Dose Naltrexone (LDN) for ALS.  The consortium analyzed data from the 31 members of PatientsLikeMe taking LDN to determine if there was evidence of benefit.  What did they find?  Efficacy data shared by these 31 ALS patients suggested that most did not notice any benefit, and side effects included headaches, nausea and diarrhea.  On this basis, along with a review of the literature, ALSU concluded that it does not recommend LDN for ALS patients at this time.  Read the full LDN study here.

Going forward, we hope that you will continue to share your evaluations of alternative and off-label treatments for ALS so that they can inform the world’s top researchers.  We’re thrilled that your data is being taken seriously by the wider medical community, and we encourage you to participate fully in this novel research project.

PatientsLikeMe member pwicks