Light therapy for improving symptoms in Parkinson's disease
Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.
This study is testing whether a special light therapy device can help improve movement and daily life for people with Parkinson's disease while they continue their usual treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | PhotoPharmics, Inc. Industry-sponsored |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04453033 on ClinicalTrials.gov |
What this trial studies
This pivotal study investigates the effectiveness of a specialized light therapy device in enhancing both motor and non-motor functions in patients with Parkinson's disease, in conjunction with their current medical treatments. The study employs a six-month double-blind, randomized controlled design, with participants using the device at home for one hour each evening. Assessments will be conducted through virtual clinic visits at baseline, week 13, and week 26, focusing on quality of life and motor function through established scales. The primary outcome measure is the Parkinson's Disease Questionnaire-39 Summary Index, while secondary endpoints include the Movement Disorders Society-Unified Parkinson's Disease Rating Scale.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Parkinson's disease who have been responsive to dopaminergic medication and have stable medication regimens.
Not a fit: Patients with atypical Parkinsonian syndromes or those experiencing significant motor fluctuations that could interfere with study participation may not benefit.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life and functional abilities of patients with Parkinson's disease.
How similar studies have performed: While light therapy has been explored in various contexts, this specific approach for Parkinson's disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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 -
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ray Dorsey, MD — University of Rochester
- Study coordinator: Dan Adams
- Email: dan.adams@photopharmics.com
- Phone: 8014947804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.