Light therapy trial shows feasibility of home studies in Parkinson’s
Fully remote design could make trials more accessible, inclusive: Study
Early data on recruitment and enrollment from Photopharmics’ Phase 3 clinical trial of its light-based, at-home therapy device for Parkinson’s disease — a novel treatment called Celeste — highlight both the interest in, and feasibility of, fully remote studies done in a patient’s home, according to the company.
Such home-based, decentralized study designs may be more inclusive, the researchers noted, as they could involve Parkinson’s patients from outside metropolitan areas who may not have easy access to clinics or traditional clinical trials.
“We are excited to share the success and insights of this fully remote trial design,” Kent Savage, CEO of Photopharmics, said in a company press release. “People with Parkinson’s who typically don’t have access to clinical trials are particularly interested in our trial.”
That trial is testing the company’s phototherapy device, which aims to better regulate the body’s circadian rhythm, or its so-called natural clock, in Parkinson’s patients. A person’s circadian rhythm is important for regulating essential bodily functions such as sleep and metabolism.
However, circadian rhythms often are poorly regulated in people with Parkinson’s, with this dysregulation associated with both motor and nonmotor symptoms of the disease, which can include sleeping problems.
Trial designs featuring home studies may help ‘break down barriers’
Photopharmics’ Celeste is a small device, similar to a tablet, that emits specific bandwidths to target photoreceptors, light-sensitive cells in the back of the eye that are involved in the regulation of circadian rhythms. It is designed to be used in addition to the current best medical treatments.
An earlier clinical trial (NCT02175472) tested the company’s Spectramax technology in 92 patients receiving stable dopamine replacement therapy. It compared patient outcomes in a group using the Celeste device versus a similar device that produced light not believed to have a therapeutic effect. The results indicated that the use of Celeste eased disease severity and nonmotor symptoms, and improved patients’ quality of life.
In the new Phase 3 clinical trial (NCT04453033), known as LIGHT-PD, participants will be assigned randomly to use the Celeste phototherapy device or a sham device, which will produce a different amount of the wavelengths thought to be effective. The light from the device, which is based on the Spectramax technology, should be angled toward the participant’s face, and used each evening in the home for one hour, while patients watch TV, eat dinner, or read. The study is slated to span a total of six months.
Study participants will be assessed at virtual clinic visits at the beginning of the trial, and again at weeks 13 and 26, or at about the three- and six-month marks. During these online videoconferences, the researchers will measure if using Celeste led to improvements in patient-reported quality of life, as well as nonmotor and motor function.
The company and its collaborators at the University of Rochester highlighted the advantages of their fully remote trial design earlier this month in a poster titled “An Entirely Remote, Home-based Phase 3 Clinical Trial of a Specialized Light Therapy Device for Parkinson’s Disease – Interest and Feasibility.” That poster was presented at the Parkinson Study Group (PSG) Annual Meeting, held Dec. 5-8, in Nashville.
Nearly 3,000 people, comprising residents of all 50 U.S. states, completed an eligibility questionnaire. Of these, 1,316 were deemed potentially eligible to participate in the trial.
This model has the potential to transform how we conduct trials for Parkinson’s disease and beyond. It’s on the cutting edge of telemedicine, showing us that access to specialists is possible for those who otherwise would not be able to participate.
“The results so far demonstrate the power of remote trials to improve accessibility and inclusion in clinical research,” Savage said. “This model has the potential to transform how we conduct trials for Parkinson’s disease and beyond. It’s on the cutting edge of telemedicine, showing us that access to specialists is possible for those who otherwise would not be able to participate.”
According to the poster, 198 screenings were completed, and patients were then enrolled by a central coordination center. The study aims to enroll 300 participants in all.
To date, 125 study participants have been randomized to either the Celeste or the control group. Their mean age is 67.8 and their mean Parkinson’s disease duration is 6.8 years.
Early findings showed that some participants faced issues with remote consent and software usage. But ultimately, device setup and operation were universally successful, according to the company.
Remote neurological evaluations, on the other hand, were conducted with little difficulty, according to the study abstract.
“Remote trials like Light for PD can break down barriers that prevent people in rural or underserved areas from accessing innovative therapies,” Savage said. “This [trial design] is about inclusivity, patient convenience, and moving closer to real-world results for therapies like Celeste.”
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