PhotoPharmics released the results of its multinational, double-blind, randomized controlled trial in Parkinson’s disease at the annual International Movement Disorders Society meeting in Hong Kong. The study is entitled “Double-blind controlled trial of Spectramax light therapy for the treatment of Parkinson’s disease patients on stable dopaminergic therapy.”
“Our study is the first long-term phototherapy trial with the objective of demonstrating the safety and efficacy of our proprietary Spectramax technology in improving the overall disease,” says Kent Savage, CEO of PhotoPharmics, in a release. “This poster presentation is a significant milestone for patients with Parkinson’s disease and showcases what may be the only adjunctive therapy to improve Parkinson’s disease symptoms on top of the dopaminergic medications that patients are likely already taking.
“At the Hong Kong conference, we will also be consulting with several leading movement disorders specialists to discuss next steps for introducing this new technology. We will also be exploring additional human clinical trials to further investigate specific bandwidth phototherapy in neurodegenerative diseases.”
The 6-month study involved 92 highly heterogenous subjects who were treated for one hour in the evening. Subjects were assessed during the ON state. A clinically meaningful improvement was found in favor of the Active group over controls on disease severity as measured by the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) (-8.0 LSM difference, p=0.07). Significance was found for the PDQ-39 (-5.7 LSM difference, p<0.05) and non-motor (MDS-UPDRS Part I = -2.5 LSM difference, p<0.01), with a trend on the ESS (-1.5 LSM difference, p=0.05).
“The circadian system is dysregulated in Parkinson’s disease, which shows a blunted circadian profile,” says Dan Adams, science officer for PhotoPharmics. “The circadian system exerts a major influence on our daily sleep and activity. So improving circadian regulation should impact both motor and non-motor problems in Parkinson’s. We know that therapeutic light is the most powerful tool for circadian regulation, and based on our experience in treating circadian-related disorders with specific bandwidth phototherapy, we believe we can make a major difference in treating PD.”
The significant non-motor improvement seen by the patients is important, as limited options are available for non-motor problems in Parkinson’s disease. The study was conducted at three CNS or neurology clinics at the Vrije Universiteit Medical Center in Amsterdam, Massachusetts General Hospital in Boston, and Aspen Clinical Research in Salt Lake City.