SIXTY MINUTE EVENING EXPOSURE OF SPECIFIC BANDWIDTH LIGHT FOR THE TREATMENT OF IDIOPATHIC PARKINSON*S DISEASE
- Conditions
- angststoornissenParkinson's disease / paralysis agitans1002803710027946
- Registration Number
- NL-OMON41705
- Lead Sponsor
- PhotoPharmics, Inc
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Males and females, with Stage II * IV, Idiopathic Parkinson*s Disease, as assessed by Hoehn-Yahr Scale
2. On optimized, stable dopamine replacement therapy for at least 1 month
1. Subjects younger than 45 years old.
2. Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study
3. Subjects who are medically complicated, medically unstable and/or have other severe co-morbid disease states, as determined by the investigator.
4. History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
5. History or current diagnosis of major psychiatric disorder including Bipolar I Disorder that could interfere with accurate assessment and effective treatment
6. Beck Depression Inventory score of greater than or equal to 14
7. Patients on stable anti-depressant dose for less than 6 weeks
8. An anticipated need for dopamine therapy change for the duration of the trial
9. Less than one month of stopping an anti-depressant or psychoactive medication
10. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-5 criteria
11. Active suicidal or homicidal ideation or plan as determined by the Investigator, or a score of 2 or higher item 9 of the BDI-II.
12. Previous use of light therapy treatment
13. Females of childbearing age, e.i. capable of becoming pregnant
14. Night shift work within the past 6 months, or planned during the investigation
15. Planned travel for more than two weeks outside of two time zones from the state in which the trial is being conducted
16. Planned travel outside of two time zones from home during the last two months of the Subject*s involvement in the Investigation
17. Current use or use within the previous 1 month of photosensitizing or other medications that in the opinion of the investigator would interfere with the safety of the subject during the trial including:
a. amiodarone,
b. benoxaprofen,
c. chlorpromazine,
d. demeclocycline,
e. fleroxacin,
f. nalidixic acid,
g. ofloxacin,
h. piroxicam,
i. porfimer,
j. psoralens,
k. quinidine,
l. temoporfin tetracycline,
m. oral isoretinoin (Accutane),
n. St. John*s wort,
o. melatonin.
18. History of significant eye trauma or disease, retinopathy, and/or cataract of a level that would significantly affect transmission or processing of light through either eye
19. Other neurological disorders that in the opinion of the investigator would interfere with the conduct of the study
20. Pre-existing major joint problems that in the opinion of the investigator would interfere with subject compliance
21. History of cerebral insult or central nervous system infection that in the opinion of the Investigator would preclude successful participation in Investigation related procedures.
22. Cognitive impairment, e.g. as determined by the Montreal Cognitive Assessment, that in the opinion of the Investigator would interfere with the conduct of the Investigation.
23. Focal neurological deficits that in the opinion of the Investigator would interfere with the conduct of the Investigation.
24. High Total Drug Burden or severe dyskinesia attributable to dopamine replacement therapy that would preclude successful participation in the Investigation related procedures or interventions in the opinion of the site Investigator. Total Drug Burden is defined as the total of the L-dopa equivalents, plus peripheral decarboxylase inh
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary effectiveness endpoint is the change in the MDS-UPDRS (Movement<br /><br>Disorders Society * Unified Parkinson*s Disease Rating Scale) composite score<br /><br>of sections II and III at Treatment Visit 3 (after six months of treatment).</p><br>
- Secondary Outcome Measures
Name Time Method