NL-OMON41705已完成不适用
SIXTY MINUTE EVENING EXPOSURE OF SPECIFIC BANDWIDTH LIGHT FOR THE TREATMENT OF IDIOPATHIC PARKINSON*S DISEASE - Light therapy for treatment of Parkinson's disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
3 期
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS CARDIOVASCULAR OUTCOMES FOLLOWING TREATMENT WITH ERTUGLIFLOZIN (MK-8835/PF-04971729) IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED VASCULAR DISEASEDiabetes Mellitus Type 210012653NL-OMON47681Pfizer7
已完成
4 期
Prospective, randomized, open label trial of six vs. twelve months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction.DAPT treatment after PCIDual-antiplatelettherapy after stent implantation10011082NL-OMON39800Maasstadziekenhuis580
已完成
3 期
A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients with Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation.split personalitySchizofrenia10037173NL-OMON43400Janssen-Cilag6
已完成
3 期
An open label, long term, safety and tolerability extension to a randomized, double-blind, placebo controlled study of LCQ908 in subjects with Familial Chylomicronemia SyndromeFamilial Chylomicronemia Syndrome10013317NL-OMON41457ovartis9
已完成
2 期
An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II Hereditary AngioedemaHereditary AngioedemaNL-OMON48865BioCryst Pharmaceuticals Inc.3