Parkinson DiseaseLIGHT-PDNCT04453033
DB RCT for Specialized Phototherapy in Parkinson's Disease.
A study testing Celeste Specialized Phototherapy Device in people with Parkinson Disease, run by PhotoPharmics, Inc. at 1 site in United States.
Trial summary
This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Celeste Specialized Phototherapy Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease as determined by the study PI, in keeping with the UK PD Society Brain Bank Criteria for the Diagnosis of PD
- Responsiveness to dopaminergic medication, as judged by the rater, and have been using treatment for at least the past 1 year
- Relatively good eyesight as attested to by participants (Corrective lenses of at least 20/60)
- Stable levodopa and other anti-PD medications for at least 28 days prior to screening -
Who cannot join
- Diagnosis of an atypical Parkinsonian syndrome
- Significant OFF state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study.
- An anticipated need for a change in dopamine replacement therapy, concomitant medications, OTC/supplements, or other alternative therapies during the participant's involvement in the investigation
- History of previous light therapy use for PD
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.
This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment.
Read the detailed description
Six month double blind, randomized controlled study with virtual clinic visits at baseline, week 13 and week 26. The Celeste specialized phototherapy device is similar to a tablet with a stand that allows the device to be angled towards the participant's face. The light is to be used each evening in the home for 1 hour, while the participant watches TV, eats dinner, reads, etc. The primary outcome measure is the Parkinson's Disease Questionnaire-39 Summary Index (PDQ-39SI). The PDQ-39 is a patient-reported, quality of life scale. The key secondary endpoint is Parts 1 and 2 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS Parts 1 and 2 measure non-motor and motor function in Parkinson's. Participants will be assessed via online videoconferences.
- Conditions
- Parkinson Disease
- Being tested
- Celeste Specialized Phototherapy Device
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celeste Specialized Phototherapy DeviceDevice
Ocular phototherapy light panel
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Active comparator | 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. Receives: Device: Celeste Specialized Phototherapy Device |
| Control Device | Sham comparator | 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. Receives: Device: Celeste Specialized Phototherapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's Disease Questionnaire-39 (PDQ-39)
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported rating scale for quality of life in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156, with higher scores representing worse severity.
Measured: 26 weeks
Secondary outcomes (1)
Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2
MDS-UPDRS Part 1: Non-motor impact of experiences of daily living. Part I has 13 questions, the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65, with higher scores representing worse severity.
MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire. Each question = 0-4, range = 0-65. with higher scores representing worse severity.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start26 Feb 2024
- Primary completion30 May 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a six-month, randomized, double-blind, controlled, parallel group study with visits at screening, baseline, weeks 13 and 26, and blinded coordinator calls throughout the study for safety and efficacy assessments. This study will use a remote trial design, which will allow participants to be recruited nationally and evaluated centrally using video conferencing. All study participants will have their eligibility assessed and confirmed by a study coordinator and a PD specialist (primary investigator). Participants will complete the secondary outcome measures, which are Patient Response Outcomes (PRO's), and will be assisted by a blinded coordinator to ensure completeness of answers. A blinded rater will conduct the Primary Outcome Measure as well as the MDS-UPDRS. All assessments will be conducted by video at Baseline, Week 13, and Week 26 visits.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhotoPharmics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Ray Dorsey, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453033
- Sponsor's protocol ID
- CT-2401
- Acronym
- LIGHT-PD
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: In addition to submitting the study design and results to www.clinicaltrials.gov, the final results of the study will be published in a peer-reviewed journal after the generation of the clinical study report. Subsequent to publication and FDA submission, PhotoPharmics intends to make the data available to qualified researchers for collaboration. The general results of the trial may also be made available to study participants during a webinar.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT04453033
- Acronym / sponsor ID
- LIGHT-PD / CT-2401
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- PhotoPharmics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment.
Detailed description
Six month double blind, randomized controlled study with virtual clinic visits at baseline, week 13 and week 26. The Celeste specialized phototherapy device is similar to a tablet with a stand that allows the device to be angled towards the participant's face. The light is to be used each evening in the home for 1 hour, while the participant watches TV, eats dinner, reads, etc. The primary outcome measure is the Parkinson's Disease Questionnaire-39 Summary Index (PDQ-39SI). The PDQ-39 is a patient-reported, quality of life scale. The key secondary endpoint is Parts 1 and 2 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS Parts 1 and 2 measure non-motor and motor function in Parkinson's. Participants will be assessed via online videoconferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a six-month, randomized, double-blind, controlled, parallel group study with visits at screening, baseline, weeks 13 and 26, and blinded coordinator calls throughout the study for safety and efficacy assessments. This study will use a remote trial design, which will allow participants to be recruited nationally and evaluated centrally using video conferencing. All study participants will have their eligibility assessed and confirmed by a study coordinator and a PD specialist (primary investigator). Participants will complete the secondary outcome measures, which are Patient Response Outcomes (PRO's), and will be assisted by a blinded coordinator to ensure completeness of answers. A blinded rater will conduct the Primary Outcome Measure as well as the MDS-UPDRS. All assessments will be conducted by video at Baseline, Week 13, and Week 26 visits.
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Active comparator | Device: Celeste Specialized Phototherapy DeviceThe 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. |
| Control Device | Sham comparator | Device: Celeste Specialized Phototherapy DeviceThe 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 may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Parkinson's disease as determined by the study PI, in keeping with the UK PD Society Brain Bank Criteria for the Diagnosis of PD
- Responsiveness to dopaminergic medication, as judged by the rater, and have been using treatment for at least the past 1 year
- Relatively good eyesight as attested to by participants (Corrective lenses of at least 20/60)
- Stable levodopa and other anti-PD medications for at least 28 days prior to screening -
Key exclusion criteria (5 listed)
- Diagnosis of an atypical Parkinsonian syndrome
- Significant OFF state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study.
- An anticipated need for a change in dopamine replacement therapy, concomitant medications, OTC/supplements, or other alternative therapies during the participant's involvement in the investigation
- History of previous light therapy use for PD
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celeste Specialized Phototherapy DeviceOcular phototherapy light panel | Device | Control Device, Investigational Device |
Primary outcome
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: 26 weeks
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported rating scale for quality of life in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156, with higher scores representing worse severity.
1 secondary outcome
Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. In addition to submitting the study design and results to www.clinicaltrials.gov, the final results of the study will be published in a peer-reviewed journal after the generation of the clinical study report. Subsequent to publication and FDA submission, PhotoPharmics intends to make the data available to qualified researchers for collaboration. The general results of the trial may also be made available to study participants during a webinar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray Dorsey, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celeste Specialized Phototherapy Device in people with Parkinson Disease, run by PhotoPharmics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Disease Questionnaire-39 (PDQ-39) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.