Trial Outcomes & Findings for Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease (NCT NCT02175472)

Last Updated: 2018-10-23

Results Overview

Part I: 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. 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. Part III: Motor Examination: This portion of the scale assesses the motor signs of PD and is administered by the evaluator. There are 18 questions, however several questions have multiple parts which are also scored. Each question 0-4, Total range=0-132. Higher score=more severe

Recruitment status

COMPLETED

Study phase

Target enrollment

92 participants

Primary outcome timeframe

Six Months

Results posted on

2018-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Spectramax Light Therapy Device Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
Overall Study STARTED	45	47
Overall Study COMPLETED	38	45
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spectramax Light Therapy Device n=45 Participants Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device n=47 Participants Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.	Total n=92 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 7.94 • n=5 Participants	65.9 years STANDARD_DEVIATION 7.55 • n=7 Participants	68.0 years STANDARD_DEVIATION 8.01 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Netherlands	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: Six Months

Outcome measures

Outcome measures
Measure	Spectramax Light Therapy Device n=44 Participants Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device n=47 Participants Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
Change in the Combined Scores (Sum) of Parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (M (MDS-UPDRS) From Baseline to Endpoint at 6 Months.	-17.7 units on a scale Standard Error 2.8	-9.7 units on a scale Standard Error 3.5

SECONDARY outcome

Timeframe: Six months

The Clinical Global Impression of Improvement is an assessment of the clinician's view of the patient's global functioning. Participants are ranked "O" at baseline. The CGI-I ranks 0 - 7, with "0" being much improved, "4" being neutral, and "7" being much worse.

Outcome measures

Outcome measures
Measure	Spectramax Light Therapy Device n=44 Participants Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device n=47 Participants Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
Change in the Clinical Global Impression- Improvement Scale (CGI-I) From Baseline to Endpoint at 6 Months.	-0.6 units on a scale Standard Error 0.1	-0.2 units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Six months

The 39 question Parkinson's Disease Questionnaire (PDQ-39) is a widely used patient reported rating scale 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 The questions are divided into eight measurement scales each comprising 3 to 10 questions. The scores for the questions in each scale are totaled and normalized to a scale of 0 - 100, that is equivalent to percent of maximum score. The scales are; Mobility (MOB): Q1-10; Activities of Daily Life (ADL): Q11-16; Emotional Well Being (EMO): Q17-22; Stigma (STI): Q23-26; Social Support (SOC): Q27-29; Cognitions (COG): Q30-33; Communication (COM) Q34-36; and Bodily Discomfort (BOD): Q37-39.

Outcome measures

Outcome measures
Measure	Spectramax Light Therapy Device n=44 Participants Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device n=47 Participants Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
Change in the Score of the Parkinson's Disease Questionnaire - 39 From Baseline to Endpoint at 6 Months	-1.3 units on a scale Standard Error 2.1	4.3 units on a scale Standard Error 1.7

SECONDARY outcome

Timeframe: Six months

The Parkinson's Disease Sleep Scale 2 (PDSS-2) is designed to assess nocturnal disability in Parkinson's disease. The PDSS-2 is a 15 question analog scale that ranks answers from 0 - 4, with 4 being worse. In addition to an overall assessment of sleep disability three aspects of sleep problems can be obtained; disturbed sleep (total of questions 1-3, 8 and 14), PD-specific nocturnal motor symptoms (total of questions 4-6, 12 and 13), and PD-specific nocturnal symptoms (Total of questions 7, 9-11 and 15). We selected the "Disturbed Sleep" subscale as a key secondary outcome measure. This subscale has a total range of 0 - 16, with 16 being more severe.

Outcome measures

Outcome measures
Measure	Spectramax Light Therapy Device n=44 Participants Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device n=47 Participants Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
Change in the Score of the Parkinson's Disease Sleep Scale-Disturbed Sleep, From Baseline to Endpoint at 6 Months.	-0.0 units on a scale Standard Error 0.6	0.7 units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: Six months

The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness to help in diagnosing sleep disorders. The ESS questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 (none) to 3 (worse) for eight different everyday situations. The total range is 0 - 24, with higher scores representing worse severity.

Outcome measures

Outcome measures
Measure	Spectramax Light Therapy Device n=44 Participants Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device n=47 Participants Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
Change in the Score of the Epworth Sleepiness Scale From Baseline to Endpoint at 6 Months.	-1.4 units on a scale Standard Error 0.6	0.1 units on a scale Standard Error 0.5

Adverse Events

Spectramax Light Therapy Device

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Control Light Device

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spectramax Light Therapy Device n=45 participants at risk Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device n=47 participants at risk Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
Cardiac disorders Transient Ischemic Attack	2.2% 1/45 • Number of events 1 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.	0.00% 0/47 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.
Musculoskeletal and connective tissue disorders Hip deterioration	0.00% 0/45 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.	2.1% 1/47 • Number of events 1 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.
Musculoskeletal and connective tissue disorders Accident	2.2% 1/45 • Number of events 1 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.	0.00% 0/47 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.
Musculoskeletal and connective tissue disorders Rib fracture	2.2% 1/45 • Number of events 1 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.	0.00% 0/47 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.

Other adverse events

Other adverse events
Measure	Spectramax Light Therapy Device n=45 participants at risk Light therapy device which emits a specific bandwidth combination and intensity of light. Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.	Control Light Device n=47 participants at risk Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
Eye disorders Eye disorders and other eye related problems	11.1% 5/45 • Number of events 5 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.	4.3% 2/47 • Number of events 2 • Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months. Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.

Additional Information

Dan Adams

PhotoPharmics, Inc.

Phone: 801-770-6960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER