Light therapy device seen to brighten life quality for those with Parkinson’s
Full trial data also show trend toward fewer motor symptoms with Celeste device
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New trial data show that Photopharmics' Celeste light therapy device improves quality of life for people with Parkinson's disease.
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The device's use also showed a trend toward reduced motor symptoms among patients.
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A larger ongoing clinical trial is now further assessing the therapy's long-term effectiveness and safety.
Light therapy using Celeste, Photopharmics’ investigational photo-neuromodulation device, was seen in a clinical trial to ease nonmotor symptoms in people with Parkinson’s disease, and to also improve quality of life for patients.
Treatment also showed a trend toward reduced motor symptoms, the study’s main goal, although this effect did not reach statistical significance.
That’s according to now-published full results of the Phase 2 clinical study (NCT02175472), which assessed the therapy’s safety and effectiveness in people with the neurodegenerative disease in the U.S. and the Netherlands. Participants used the light therapy daily at home for six months during the trial.
These Phase 2 findings informed the design of an ongoing Phase 3 trial, dubbed LIGHT-PD (NCT04453033), which is fully enrolled and expected to be completed this year. Anticipated data collection is ongoing through April, with continued evaluation of the treatment’s long-term safety and efficacy.
“The Phase 2 study results provided critical learning that helped refine the design and powering of our Phase 3/pivotal trial,” Dan Adams, chief science officer at Photopharmics, said in a company press release. “That translational step is exactly what this stage of development is intended to accomplish.”
The study, “A double-blind, controlled trial of circadian effective light therapy in patients with Parkinson’s disease,” was published in the journal Neurotherapeutics. The lead author was a scientist with Othree Consulting, and the eight-person research team also included Adams.
Disruptions to the body’s internal clock, or circadian rhythm, are thought to contribute to certain nonmotor symptoms of Parkinson’s, including fatigue and sleep problems. This exacerbates physical and cognitive decline and can significantly impact patients’ quality of life.
Now-concluded study tested light therapy device for at-home use
Celeste is a compact device that emits specific wavelengths of light to stimulate photoreceptors, which are light-sensitive cells in the back of the eye that help regulate circadian rhythms. The device-emitted light is intended for at-home use, in combination with standard Parkinson’s treatments.
The Phase 2 trial enrolled 92 Parkinson’s patients, mostly men (68.1%), with a mean age of 68. All had moderate disease as assessed by the Hoehn & Yahr score. The participants were randomly assigned to receive one hour of either light therapy or a placebo light, not thought to provide clinical benefit, every evening for six months, as an adjunct to standard treatments.
Light was delivered using a table-top device consisting of a light panel with an on/off switch, placed at the participants’ homes. Patients were able to perform activities such as eating, reading, or watching TV while receiving light therapy.
After six months, people who received light therapy showed a greater improvement in nonmotor symptoms, such as sleep, mood, and daily functioning, than those who received the placebo treatment. While use of the device did not lead to a statistically significant reduction in motor symptoms, there was a trend toward lower scores in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale combined parts 1-3, which measure motor function, in the light therapy group.
[Trial data on the device] showed a strong trend toward efficacy, particularly for nonmotor features, which warrants further investigation.
Patients who received the light therapy also experienced significant improvements in their quality of life, as measured using the Parkinson’s Disease Questionnaire. Investigators also observed trends toward greater overall benefit and effectiveness compared with the placebo group. There was also a trend toward reduced excessive daytime sleepiness, the study noted.
The light therapy was well tolerated, with no serious adverse events reported. The most common side effects were nervous system issues such as dizziness, headache, worsening Parkinson’s or dyskinesia (involuntary movements), or muscle spasms, as experienced by 10% of participants. Injuries such as falls and fractured bones were experienced by 8% of patients. A total of 6.5% had eye-related issues, including dry eyes, teary eyes, eye pain, and decreased vision.
According to researchers, although the study “did not meet statistical significance for the primary endpoint,” it “showed a strong trend toward efficacy, particularly for nonmotor features, which warrants further investigation.”
Larger trial now testing Celeste device vs. placebo light
The now-underway Phase 3 trial enrolled 350 people with Parkinson’s who were randomly assigned to use the Celeste phototherapy device or a placebo light for one hour daily for six months, similar to the Phase 2 design.
The trial’s main outcome is to assess the impact of phototherapy on patients’ quality of life. Secondary goals include the therapy’s effect on patients’ motor and nonmotor symptoms, daytime sleepiness, disease progression, sleep problems, mental health, and cognitive and motor functions.
Patients’ assessments will be performed via online videoconferences, according to the trial design.
Kent Savage, CEO of Photopharmics, said the “full enrollment in our Phase 3 trial reflects the strong engagement of the Parkinson’s disease community and our clinical partners.”
Photopharmics noted that further evaluations, once data are collected, will be done to assess the therapy’s long-term safety and clinical outcomes.
“We look forward to sharing trial results when the trial concludes,” Savage said.
