Parkinson Disease Clinical Trial
Official title:
Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial
Verified date | April 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is the first clinical trial using sodium oxybate for the treatment of REM sleep behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal, 2016; Moghadam, 2017).
Status | Completed |
Enrollment | 24 |
Est. completion date | February 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | Inclusion Criteria: - 40-85 years old - With or without Parkinson's disease - Experiencing RBD episodes on average at least 2x/week or 8x/month - Able to report RBD episodes themselves or via a partner witness Exclusion Criteria: - History of falls during ambulation in the last 6 months despite adequate neurologic treatment - Requirement of an ambulatory device at home - Inadequately treated symptomatic orthostatic hypotension - BMI > 35 - Untreated or uncontrolled OSA (4%AHI>15) - Cognitive impairment resulting in inability to comply with treatment instructions - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Jazz Pharmaceuticals |
United States,
Liebenthal J, Valerio J, Ruoff C, Mahowald M. A Case of Rapid Eye Movement Sleep Behavior Disorder in Parkinson Disease Treated With Sodium Oxybate. JAMA Neurol. 2016 Jan;73(1):126-7. doi: 10.1001/jamaneurol.2015.2904. No abstract available. — View Citation
Moghadam KK, Pizza F, Primavera A, Ferri R, Plazzi G. Sodium oxybate for idiopathic REM sleep behavior disorder: a report on two patients. Sleep Med. 2017 Apr;32:16-21. doi: 10.1016/j.sleep.2016.04.014. Epub 2016 Jun 7. — View Citation
Shneerson JM. Successful treatment of REM sleep behavior disorder with sodium oxybate. Clin Neuropharmacol. 2009 May-Jun;32(3):158-9. doi: 10.1097/WNF.0b013e318193e394. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of RBD Episodes in One Month (Per Patient RBD Log) | Patients record any episode of dream enactment, such as talking, shouting, kicking, or punching, etc. | Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks) | |
Primary | Number of Severe of RBD Episodes in One Month (Per Patient RBD Log) | Patients record any episode of dream enactment, such as talking, shouting, kicking, or punching, etc. Severity is scored from 1 to 3 (1: least severe, 3 most severe):
non injurious behaviors: facial expressions, non-aggressive vocalizations (mumbling, gentle talking, casual conversation, singing, laughing...), twitches, gentle shaking, non-aggressive movements of fingers, arms or legs...; potentially injurious: punching, kicking, arm flailing or thrashing around, at least one limb or head out of bed, sitting up in bed, crawling, attempting to stand up or leave bed, near falls, cursing, screaming, shouting, yelling, or any behavior requiring bed partner to wake up participant; injurious: any contact with bed partner (hitting or grabbing), wall or furniture, any fall or leaving bed (doving out, walking, jumping). The number of injurious (severe) episodes is reported. |
Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks) | |
Secondary | Number of Responders According to the CGI Efficacy Scale (CGI-E) | Clinical Global Impression-Efficacy index (CGI-E) is a 4x4 rating scale that assesses the therapeutic effect (Marked, Moderate, Minimal, Unchanged or worse) of treatment medication and associated side effects (none, do not significantly interfere with patient's functioning, significantly interfere with patient's functioning, Outweigh therapeutic effect). Therapeutic effect: Marked and Side effects: None is the best. Therapeutic effect: Unchanged or worse and Side effects: outweigh therapeutic effect is the worst. Each combination of an estimated therapeutic effect and side effect is assigned a score from 1-16, 1 being the best, 16 being the worst.
Participants scoring below 4 were considered to be "responders." |
Assessed at week 12 (end of treatment period). | |
Secondary | Number of Responders According to the CGI Improvement Scale (CGI-I) | Clinical Global Impression-Improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1. Very much improved, 2. Much improved, 3. Minimally improved, 4. No change, 5. Minimally worse, 6. Much worse, 7. Very much worse. 1 is the best and 7 is the worst.
Participants scoring below 4 were considered to be "responders." |
Assessed at week 12 (end of treatment period). | |
Secondary | Epworth Sleepiness Scale (ESS) Score | Epworth Sleepiness Scale (ESS) is a scale to assess patients' general level of sleepiness. Patients choose the most appropriate number (0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing) for the each situation: Sitting and reading, Watching TV, Sitting and inactive in a public place, As a passenger in a car for an hour, Lying down to rest in the afternoon, Sitting and talking to someone, Sitting quietly after a lunch, While stopped for a few minutes in the traffic in a car. 0-10: Normal range, 10-12: Borderline, 12-24: Abnormal. Participants recorded their scores for 28 days at baseline and during the 28 days leading up to week 12; scores were then averaged to calculate the score for each time point per participant, and then the median for all participants is reported. | Assessed at baseline and week 12 | |
Secondary | RBD Episode Severity and Frequency During REM Sleep by Quantitative Video-PSG (Polysomnography) Analysis Per 10 Minutes of REM Sleep | The average number of dream-enactment episodes (resulting in motor behaviors, or movements) weighted for severity. Frequency and severity were calculated as the sum of RBD episodes (frequency) times severity (mild = 1; moderate = 5, severe = 10) occurring over one night's sleep, then averaged to calculate the number of episodes per 10 minutes of REM sleep. | Assessed at baseline and week 12 (average approximately 8 hours to assess at each time point) | |
Secondary | Change in Ambulatory Measures of Movements During Sleep Using Actigraphy | Measure of "activity score" using in-home 4-week actigraphy | Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks) |
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