A new Phase 3 clinical trial will test PhotoPharmics‘ light-based, at-home therapy device — called Celeste — for Parkinson’s disease.
The “Celeste Light for PD Trial” — a collaboration between PhotoPharmics and the Center for Health + Technology (CHeT) at the University of Rochester Medical Center — will be conducted at home via telemedicine and is set to begin in the fall. More information is available here.
Our body’s “natural clock” — the circadian rhythm — is key for regulating essential functions such as sleep or metabolism. However, in people with Parkinson’s, circadian rhythms are poorly regulated. This dysregulation is associated with the development of both motor and non-motor symptoms characteristic of the disease.
PhotoPharmics’s Celeste device uses a combination of light intensities and bandwidths believed to have a therapeutic effect.
Preclinical studies have suggested that light therapy improves the circadian rhythm and may be an effective therapy for easing both motor and non-motor features of Parkinson’s disease.
In a previous clinical trial (NCT02175472), 92 Parkinson’s patients — ages 45 or older, and all taking dopaminergic therapy — received either phototherapy or a placebo light for one hour each evening for six months.
The results showed that light therapy led to a clinically meaningful improvement on disease severity, as assessed through the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), a four-part assessment of motor and non-motor Parkinson’s symptoms.
Patients given light therapy showed a significant reduction in non-motor symptoms (measured through Part 1 of the MDS-UPDRS), as well as a significant improvement in their quality of life and a tendency to reduce daytime sleepiness.
“Our first trial showed improvement in quality of life on top of best managed care,” Dan Adams, science officer at PhotoPharmics, said in a press release.
The improvements in the MDS-UPDRS Part 1 “is something we have never seen before, and may signal for the first time, broad, general improvement in non-motor symptoms,” he said.
In the pivotal Phase 3 trial (NCT04453033), participants will be assigned randomly to use the Celeste phototherapy device or a sham device (producing the same bandwidths of light, but at different intensities) for one hour daily, while they watch TV, eat dinner, read or use the computer, for a total of six months.
The trial’s main (primary) outcome is to assess the impact of the phototherapy device on patients’ motor and non-motor symptoms, assessed in Part 1 and Part 2 of the MDS-UPDRS.
Assessments will be performed via teleconference. “A stay-at-home trial featuring a non-invasive device is perfect for our time,” said Ray Dorsey, lead investigator for the trial and director of CHeT.
“Our team will assess a patient’s progress via video conference in the most natural and accurate setting — the convenience of their own home. Anyone with Parkinson’s from across the country can apply, even those in remote locations as long as they have an internet connection,” Dorsey added.
Recently, the Celeste phototherapy device was granted breakthrough device designation by the U.S. Food and Drug Administration (FDA), a designation given to medical devices with the potential to offer more effective treatment for life-threatening or debilitating diseases.
The positive outcomes of the Celeste phototherapy device on the MDS-UPDRS in the first trial probably is “why the FDA granted this therapy a Breakthrough Designation,” said Adams, as “treatment options overall remain limited … and new treatments for non-motor symptoms in PD remains a top priority.”
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