Photopharmics' Phase 3 LIGHT-PD trial is demonstrating the feasibility and potential of fully remote, home-based studies for individuals with Parkinson's disease. The trial is evaluating Celeste, a novel light-based therapy device designed to regulate circadian rhythms and alleviate both motor and non-motor symptoms associated with Parkinson's.
Remote Trial Design Enhances Accessibility
The LIGHT-PD trial's remote design aims to overcome traditional barriers to clinical trial participation, particularly for patients in rural or underserved areas. By conducting the study entirely in patients' homes, researchers hope to broaden access to innovative therapies and generate real-world results.
Kent Savage, CEO of Photopharmics, emphasized the importance of inclusivity, stating, "Remote trials like Light for PD can break down barriers that prevent people in rural or underserved areas from accessing innovative therapies...This [trial design] is about inclusivity, patient convenience, and moving closer to real-world results for therapies like Celeste."
Celeste Light Therapy for Parkinson's Disease
Celeste is a small, tablet-like device that emits specific bandwidths of light to target photoreceptors in the eye, which play a crucial role in regulating circadian rhythms. Circadian rhythm dysregulation is common in Parkinson's disease and is associated with motor and non-motor symptoms, including sleep disturbances.
The device is intended to be used in conjunction with existing medical treatments. Participants in the LIGHT-PD trial use the device for one hour each evening while engaging in activities such as watching TV or reading.
Trial Design and Early Findings
The LIGHT-PD trial (NCT04453033) is a randomized, sham-controlled study. Participants are randomly assigned to receive either the Celeste phototherapy device or a sham device that emits different wavelengths of light. The trial spans six months, with virtual clinic visits at baseline, 13 weeks, and 26 weeks.
The primary outcome measure is patient-reported quality of life, with secondary endpoints assessing motor and non-motor function. Nearly 3,000 individuals across all 50 U.S. states completed an eligibility questionnaire, with 1,316 deemed potentially eligible.
As of the latest update, 125 participants have been randomized, with a mean age of 67.8 years and a mean Parkinson's disease duration of 6.8 years. Initial findings indicate that while some participants experienced challenges with remote consent and software usage, device setup and operation were generally successful. Remote neurological evaluations were conducted with minimal difficulty.
Implications for Future Parkinson's Research
The LIGHT-PD trial's innovative remote design has the potential to transform how clinical trials are conducted for Parkinson's disease and other conditions. By leveraging telemedicine and decentralized approaches, researchers can improve accessibility, inclusivity, and the generation of real-world evidence.
"The results so far demonstrate the power of remote trials to improve accessibility and inclusion in clinical research," said Savage. "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."
