2 posts tagged “ALS clinical trials”

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


PatientsLikeMe at the 2nd Annual White Coat Affair for ALS TDI

Posted November 28th, 2012 by

On Friday, November 2nd, several PatientsLikeMe team members donned their finest to attend the 2nd Annual White Coat Affair, a charity gala benefiting the ALS Therapy Development Institute (ALS TDI).  Founded by PatientsLikeMe Co-Founder and Chairman Jamie Heywood in 1999, ALS TDI is the world’s most advanced research laboratory dedicated to ALS, also known as Lou Gehrig’s disease.

The PatientsLikeMe Team Along with ALS Patient Steve Saling (Front) at the 2nd Annual White Coat Affair for ALS TDI

This gala fundraiser was held in conjunction with ALS TDI’s 8th Annual Leadership Summit, which included in-depth scientific presentations by top ALS researchers, a discussion panel with industry leaders and an awards ceremony honoring individuals who have made extraordinary contributions to ALS research and advocacy.  (View the summit webcast here.)  PatientsLikeMe was a proud sponsor of this annual gathering of the most influential minds in the ALS community.  In particular, we were honored to witness the posthumous awarding of the Stephen Heywood Patients Today Award – given annually to an individual who exemplifies what it means to be an educator, role model and advocate – to beloved PatientsLikeMe member Persevering (Rob Tison).

Keeping with the Laboratory Theme, The Name Cards Were Inspired by the Periodic Table of Elements

Held at the Fairmont Copley Plaza in Boston the next night, A White Coat Affair was an opportunity for summit attendees to unwind and socialize via cocktails, a dinner program, live music and dancing.  In honor of the theme, servers wore white lab coats, name cards were labeled like the periodic table and vases were filled with brightly colored liquid to resemble lab tubes.  A special highlight of the dinner program this year was the Young Perspectives on ALS segment, which featured the stories of two young people living with ALS (Corey Reich and Pete Frates) as well as four young people who are the children of ALS patients (Katie Shambo, Sam Ketchum, Jenn Sutherland and Alex Heywood).

As you might have guessed, Alex Heywood is the son of Stephen Heywood and nephew of PatientsLikeMe Co-Founders Jamie Heywood and Ben Heywood.  Both ALS TDI and PatientsLikeMe were inspired by Stephen’s seven-year battle with ALS, a rapidly progressive neurodegenerative disease with an average life expectancy of two to five years following diagnosis.

Young ALS Patients and the Sons and Daughters of ALS Patients Were the Focus of This Year's Dinner Program

Approximately 350 guests attended A White Coat Affair, helping to raise $450,000 towards ALS TDI’s efforts to discover and develop effective treatments for ALS. After a decade of progress, the institute is entering a time of great promise, with several therapies in clinical trials and their own work on Gilenya (a drug currently approved for treating multiple sclerosis) and other potential therapeutics moving into the clinical realm.  Learn more about ALS TDI’s current research projects here.

To see more photos from the 2nd Annual White Coat Affair, visit the event’s Facebook page.