Status:
ACTIVE_NOT_RECRUITING
DB RCT for Specialized Phototherapy in Parkinson's Disease.
Lead Sponsor:
PhotoPharmics, Inc.
Collaborating Sponsors:
University of Rochester
Conditions:
Parkinson Disease
Eligibility:
All Genders
45+ years
Phase:
NA
Brief 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.
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 al...
Eligibility Criteria
Inclusion
- 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 -
Exclusion
- 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
- \-
Key Trial Info
Start Date :
February 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04453033
Start Date
February 26 2024
End Date
August 30 2026
Last Update
November 13 2025
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642