Category: Parkinson’s Disease: Clinical Trials
Objective: To determine if either once or twice-daily bright white light therapy (BWLT) improves sleep sufficiently relative to two control LT conditions to warrant proceeding to a phase 3 efficacy trial and to select the superior dose frequency to carry forward. Secondary aims were to determine whether once-weekly BWLT was a non-inferior control relative to twice-daily dim red light therapy (DRLT), to estimate the effect of daily BWLT on fatigue in PD, and to determine adherence to LT.
Background: Several studies of LT in PD have demonstrated improvements in sleep. Specific LT parameters require further study, including optimal frequency, duration, intensity, and spectral properties of the LT.
Method: ENLITE PD was a 16-week, randomized, phase 2, parallel-group, placebo-controlled, dose-selection trial of LT in PD participants with sleep disruption. Participants were randomized to 8 weeks of one of four conditions: twice-daily BWLT, once-daily BWLT, once-weekly BWLT, and twice-daily DRLT. The primary outcome was the PDSS-2 score. Secondary endpoints included the PFS-16 score and the proportion of days with adherence to LT.
Results: 150 participants (93 M) were randomized across 25 NeuroNEXT sites. The mean age was 67 (SD 8.6), age at PD diagnosis was 61 (9.0) and years since PD diagnosis was 6.3 (4.5). The mean PDSS-2 and PFS-16 scores were 17.1 (6.73) and 46 (14.3), respectively. The trial did not meet it’s “go” criteria since neither daily BWLT group showed sufficient improvement over both of the control groups. The mean 8-week change in PDSS-2 score in twice-daily BWLT group was -2.6 (95% −4.4, −0.7) compared with -1.5 (-3.3, 0.3) in once-daily BWLT, -0.4 (-2.2, 1.4) in once-weekly BWLT, and -1.8 (-3.6, 0.1) in twice-daily DRLT groups. The mean change in PDSS-2 score of once-weekly BWLT compared with twice-daily DRLT was 1.4 (-1.2, 3.9). The mean change from baseline in PFS-16 score in twice-daily BWLT group was -6.4 (-9.8, -3.0) compared with -2.2 (-5.5, 1.1) in once-daily BWLT, -0.5 (-3.9, 2.8) in once-weekly BWLT, and -3.8 (-7.3, -0.4) in twice-daily DRLT groups. Mean adherence to LT was 63%-86%.
Conclusion: ENLITE PD did not meet the criteria for advancing LT to a larger efficacy trial. LT was safe, well-tolerated with good adherence. Dim red light may not be an ideal placebo. Once-weekly BWLT was inert and can be considered as a placebo in LT trials in PD.
To cite this abstract in AMA style:
A. Videnovic, E. Macklin, C. Coffey, M. Cudkowicz, HJ. Cho, J. Ohayon, A. Amara, K. Marder, P. Zee, C. Desir, H. Ernst, E. Steinhart, M. Costigan, A. Gudjonsdottir, D. Ecklund, M. Chase, S. Criswel, D. Charles, J. Coleman, A. Espay, A. Hung, S. Kadimi, A. Killoran, L. Luo, R. Malkani, J. Margolesky, J. Marsella, C. Maurer, D. Mihaila, P. Moretti, A. Park, P. Phielipp, H. Sarva, B. Shah, H. Shill, A. Siderowf, V. Suski, J. Tate, W. Tse, K. Wyant, L. Zhang, E. Klerman. ENLITE PD – A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson’s Disease [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/enlite-pd-a-dose-selection-trial-of-light-therapy-for-impaired-sleep-in-parkinsons-disease/. Accessed November 21, 2024.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/enlite-pd-a-dose-selection-trial-of-light-therapy-for-impaired-sleep-in-parkinsons-disease/