Phototherapy for Parkinson's Disease

(LIGHT-PD Trial)

Overseen By Ray Dorsey, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: PhotoPharmics, Inc.

Must be taking: Dopaminergic medications

Disqualifiers: Atypical Parkinsonian syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether light therapy can improve both movement and non-movement symptoms in people with Parkinson's disease. The Celeste Specialized Phototherapy Device, resembling a large tablet, emits a specific type of light believed to aid alertness and daily rhythms. Participants will receive either the active light device or a similar-looking control device that emits a different light. The trial seeks individuals who have had Parkinson's disease for at least a year, respond well to their current medication, and have sufficient eyesight to see well with corrective lenses. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future Parkinson's treatments.

Will I have to stop taking my current medications?

The trial requires that you stay on your current Parkinson's medications without changes for at least 28 days before starting the study and during your participation.

What prior data suggests that the Celeste Specialized Phototherapy Device is safe for Parkinson's disease patients?

Research has shown that the Celeste Specialized Phototherapy Device is generally easy for patients to use. In earlier studies, patients using the device experienced better symptom relief and fewer side effects compared to those using only medication. This suggests the device is likely safe. It emits a gentle light and is designed to be non-invasive and simple for home use. Importantly, no major reports of negative effects have emerged from using the device, making it a promising option for managing Parkinson's disease symptoms with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Parkinson's Disease, like levodopa and dopamine agonists, focus on managing symptoms by boosting dopamine levels in the brain. However, the Celeste Specialized Phototherapy Device stands out because it uses specific light wavelengths thought to influence circadian rhythms and alertness, potentially offering a new way to alleviate symptoms. This non-invasive approach provides a soothing, soft glow, making it a novel, patient-friendly option. Researchers are excited because this could open doors to a treatment that not only targets symptoms differently but also integrates easily into daily life without the need for medications.

What evidence suggests that the Celeste Specialized Phototherapy Device is effective for Parkinson's disease?

Research has shown that the Celeste Specialized Phototherapy Device, which participants in this trial may receive, might improve symptoms of Parkinson's disease, including movement and non-movement issues. Studies have found that people using this device experienced better results and enjoyed a higher quality of life. This therapy may also reduce the need for medication, potentially leading to fewer side effects. The device emits specific types of light that are believed to affect the body's internal clock and alertness, which might help manage Parkinson's symptoms. Early evidence suggests that this light therapy could benefit people with diseases like Parkinson's. ^{1 3 5 6 7}

Who Is on the Research Team?

Ray Dorsey, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who respond to dopaminergic medication, have been on treatment for at least a year, and have relatively good eyesight (corrective lenses are okay). They must be stable on their current Parkinson's medications for at least 28 days before the study starts.

Inclusion Criteria

My Parkinson's medication doses have been stable for the last 28 days.

I have been responding to dopamine medication for over a year.

Relatively good eyesight as attested to by participants (Corrective lenses of at least 20/60)

Exclusion Criteria

I have been diagnosed with an unusual form of Parkinson's disease.

I have used light therapy for Parkinson's disease before.

Significant OFF state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants use the Celeste specialized phototherapy device each evening for 1 hour at home

26 weeks

3 visits (virtual) at baseline, week 13, and week 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Celeste Specialized Phototherapy Device

Trial Overview The trial is testing if a Celeste Specialized Phototherapy Device can improve both movement and non-movement symptoms in those with Parkinson’s Disease when used alongside their regular medications.

How Is the Trial Designed?

Group I: Investigational Device Active Control 1 Intervention

The Celeste device resembles a large tablet. It has a protective cover that folds into a stand and is magnetically attached to the back of the device. It produces a low intensity of specific bandwidths of light believed to be responsible for circadian and alerting responses in humans. The overall emission produces a pleasing soft glow of light.

Group II: Control Device Placebo Group 1 Intervention

The Control device is identical in appearance to Celeste. When turned on, the device emits a soft diffused light that is indistinguishable in color from the Active Device. However, this device produces a different amount of the specific wavelengths thought to be effective in the Active Device. It is impossible to tell the difference between the sham device and the active device by looking at them.

Who Is Running the Clinical Trial?

PhotoPharmics, Inc.

Lead Sponsor

Trials

3

Recruited

470+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Published Research Related to This Trial

Phototherapy has become a key treatment method in dermatology over the past 20 years, effectively suppressing disease processes and preventing the underlying causes of various skin conditions.

While much of phototherapy is still based on empirical evidence, advances in photoimmunology and molecular biology suggest that its effectiveness may be linked to the modulation of the immune system, primarily through immunosuppressive effects of ultraviolet radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of immunomodulation in diseases responsive to phototherapy. Beissert, S., Schwarz, T.[2019]

Photodynamic therapy, using the drug Photofrin activated by red light, has shown promising results in treating various tumors and has been approved for clinical use in several countries.

Research is ongoing into second-generation photosensitizing agents that may offer advantages over Photofrin, potentially enhancing the effectiveness of photodynamic therapy in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of photodynamic therapy. Carruth, JA.[2007]

A retrospective study involving 129 Parkinson's disease patients indicated that light therapy, when combined with controlled dopamine replacement therapy, can lead to significant improvements in motor and non-motor symptoms, especially in patients who adhered to the treatment regimen.

Patients who consistently followed the light therapy showed better outcomes and a reduced need for medication, resulting in fewer side effects compared to those who were less compliant or discontinued treatment, suggesting that light therapy may help slow the progression of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A historical justification for and retrospective analysis of the systematic application of light therapy in Parkinson's disease. Willis, GL., Moore, C., Armstrong, SM.[2022]

A newly developed mirror system for intraoperative photodynamic therapy (PDT) using talaporfin sodium showed approximately 70% energy efficiency and did not cause complications during use in 9 patients with malignant glioma.

The use of this mirror allowed for effective PDT, as no recurrences were observed at the irradiated sites, indicating its potential to enhance treatment outcomes in glioma surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of the mirror irradiation technique in photodynamic therapy for malignant glioma. Fukami, S., Akimoto, J., Nagai, K., et al.[2021]

This clinical trial is investigating the safety and efficacy of a novel transcranial LED helmet device called 'PDNeuro' for treating symptoms of Parkinson's disease in 40 participants over 24 weeks, using a randomized placebo-controlled design.

The study aims to assess improvements in mobility, fine motor skills, and cognition, with results expected to inform future larger trials on the effectiveness of photobiomodulation therapy in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson's disease. McGee, C., Liebert, A., Herkes, G., et al.[2022]

A survey of 54 phototherapy devices in Kaduna State, Nigeria, revealed that 59.3% were locally fabricated, with many lacking essential features like adjustability and high-quality lamps, which are crucial for effective treatment of neonatal jaundice.

Only three of the locally fabricated devices provided adequate irradiance levels, indicating that most of these devices functioned sub-optimally and need improvements in design to enhance their effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making Locally Fabricated Phototherapy Devices Work Better. Abdulkadir, I., Lawal, S., Adebiyi, MN., et al.[2020]

Photodynamic therapy (PDT) combines a photosensitizer, specific light, and oxygen to generate a localized therapeutic effect, primarily through the production of high-energy singlet oxygen, making it an effective treatment system for various conditions.

PDT has been successfully used in clinical applications such as treating esophageal cancer and actinic keratoses, with ongoing research showing promising results and minimal toxicity for a range of diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy systems and applications. Marcus, SL., McIntyre, WR.[2005]

Photobiomodulation has shown promise in improving locomotive behavior and neuroprotection in animal models of Parkinson's disease, with early human studies indicating positive effects on non-motor symptoms.

The review suggests that combining direct intracranial light delivery with indirect extracranial stimulation could optimize therapeutic outcomes for Parkinson's disease, addressing the challenges of reaching deep brain regions affected by the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Use of Intracranial and Extracranial (Remote) Photobiomodulation Devices in Parkinson's Disease: A Comparison of Direct and Indirect Systemic Stimulations. Johnstone, DM., Hamilton, C., Gordon, LC., et al.[2021]

In a controlled trial involving patients with Parkinson's disease who had previously used bright light therapy (BT) for 4 months to 5 years, those who continued with polychromatic light therapy showed significant improvements in motor and secondary symptoms, as measured by various scales including the MDSUPDRS and PDQ-39.

Patients who switched to red light or discontinued BT experienced deterioration in their symptoms, highlighting the efficacy of polychromatic light therapy in managing both primary and secondary symptoms of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polychromatic Light Exposure as a Therapeutic in the Treatment and Management of Parkinson's Disease: A Controlled Exploratory Trial. Willis, GL., Boda, J., Freelance, CB.[2020]

Light therapy (LT) significantly improves motor function in patients with Parkinson's disease, with a mean difference of -4.68 in motor scores compared to controls, indicating its potential as an effective non-pharmacological treatment.

LT also positively impacts non-motor symptoms, showing significant reductions in depression and improvements in sleep disturbances, suggesting a broad therapeutic benefit for individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Light Therapy as a Home Treatment for Motor and Non-Motor Symptoms of Parkinson Disease: A Meta-Analysis. Sun, W., Yan, J., Wu, J., et al.[2022]

Citations

1. photopharmics.com photopharmics.com/

PhotoPharmics: Specialized Phototherapy A breakthrough therapy for people living with Parkinson's disease. Specialized phototherapy addresses both motor and non-motor symptoms.

2. neurologyadvisor.com neurologyadvisor.com/news/clinical-trial-specialized-phototherapy-parkinson-disease-light-pd/

Specialized Phototherapy in Parkinson Disease (LIGHT-PD) Double-blind, randomized controlled trial to demonstrate the efficacy of Celeste® specialized phototherapy for the treatment of Parkinson disease (PD).

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/photopharmics-kickstarts-phototherapy-trial-for-parkinsons-disease/

Photopharmics kickstarts phototherapy trial for Parkinson's ... Celeste showed improvements in non-motor symptoms, and in the quality of life for Parkinson's patients in previous clinical trials, such as the ...

4. photopharmics.com photopharmics.com/clinical-pathway/

Clinical Pathway Early data and our mechanistic work suggest that Celeste specialized phototherapy can provide clinical benefit in other neurodegenerative and neuropsychiatric ...

5. withpower.com withpower.com/trial/phase-parkinson-disease-10-2020-1848c

Phototherapy for Parkinson's Disease (LIGHT-PD Trial) Patients who consistently followed the light therapy showed better outcomes and a reduced need for medication, resulting in fewer side effects compared to those ...

6. photopharmics.com photopharmics.com/photopharmics-announces-first-subject-completes-fda-pivotal-clinical-trial-for-the-celeste-device-in-parkinsons/

PhotoPharmics Announces First Subject Completes FDA ... The “Light for PD” trial aims to demonstrate the safety and efficacy of Celeste, PhotoPharmics' non-invasive phototherapy device in treating PD.

7. parkinsonsnewstoday.com parkinsonsnewstoday.com/news/feasibility-home-studies-parkinsons-seen-light-therapy-trial/

Light therapy trial shows feasibility of home studies in ... The results indicated that the use of Celeste eased disease severity and nonmotor symptoms, and improved patients' quality of life. In the new ...