Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04006925
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Emmanuel During, Stanford University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
REM Sleep Behavior Disorder Drug: Sodium Oxybate Other: Placebo Phase 4

Detailed Description:

Rapid eye movement sleep behavior disorder (RBD) is a condition resulting in violent dream-enactment during sleep which affects millions of individuals in the United States, however therapies for RBD are limited and cause significant side effects. As a result, despite using a combination of drugs, a large number of patients with RBD continue to act out violent dreams causing severe self-injuries or injuries to their bed partners. Prior studies and our experience have shown that sodium oxybate can be effective in these cases of treatment-resistant RBD. This study would therefore evaluate the efficacy and tolerance of sodium oxybate in this patient population.

This study is an 8-week trial comparing sodium oxybate versus placebo randomly assigned to patients with treatment-resistant RBD, i.e. individuals who have insufficiently responded or tolerated melatonin and clonazepam. The study uses a double-blind design (participants, staff, and investigators will not know which drug between active drug and placebo is given to participants), and will measure treatment efficacy based on patients, partners and clinicians report, and objective outcomes based on in-home actigraphy and in-lab polysomnography before and after intervention.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arm Intervention/treatment
Active Comparator: Sodium Oxybate (SXB) arm
Sodium Oxybate (SXB) will be dispensed to the participants.
Drug: Sodium Oxybate
Sodium Oxybate will be titrated up weekly by 1.5g nightly dose increments from an initial 4.5g total nightly dose (which could be given in two unequal doses if needed, or one single dose no greater than 4.5g) to an optimal individual dose based on clinical response on RBD symptoms and tolerance, to a maximum nightly dose of 9g ("flexible dose" period lasting up to 8 weeks). The optimal dose will then be continued for at least 4 weeks ("stable dose").

Placebo Comparator: Placebo (PBO) arm
Placebo will be dispensed to the participants.
Other: Placebo
Placebo will be similar in appearance, smell and flavor to the subjects, so that the investigators and participants will be unable to distinguish it from sodium oxybate.




Primary Outcome Measures :
  1. Number of RBD episodes in one month (per patient RBD log) [ Time Frame: last month of treatment compared to 1-month baseline (28 days) ]
    Patients record any episode of dream enactment, such as talking, shouting, kicking, or punching, etc.

  2. Severity of RBD episodes in one month (per patient RBD log) [ Time Frame: last month of treatment compared to 1-month baseline (28 days) ]

    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):

    1. 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...;
    2. 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;
    3. injurious: any contact with bed partner (hitting or grabbing), wall or furniture, any fall or leaving bed (doving out, walking, jumping).


Secondary Outcome Measures :
  1. Change from baseline in the CGI efficacy scale (CGI-E) [ Time Frame: last month of treatment compared to 1-month baseline (28 days) ]
    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.

  2. Change from baseline in the CGI improvement scale (CGI-I) [ Time Frame: last month of treatment compared to 1-month baseline (28 days) ]
    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.

  3. Number of Epworth Sleepiness Scale (ESS) [ Time Frame: last week of treatment compared to baseline week (7 days) ]
    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

  4. Reduction in RBD episodes severity and frequency during REM sleep by quantitative video-PSG (polysomnography) analysis [ Time Frame: One night, comparing treatment PSG versus baseline PSG ]
    Measure of RBD severity in terms of motor and vocalization behaviors, measure of RBD episodes density measured as dream-enactment episodes per REM sleep minute

  5. Reduction in ambulatory measures of movements during sleep using actigraphy [ Time Frame: Last month of treatment compared to 1-month baseline (28 days) ]
    Measure of "activity score" using in-home 4-week actigraphy

  6. Reduction in ambulatory measures of movements during sleep using actigraphy [ Time Frame: Last month of treatment compared to 1-month baseline (28 days) ]
    Measure of "activity index" using in-home 4-week actigraphy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40-80 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 > 32
  • Untreated or uncontrolled OSA (AASM AHI>15)
  • Cognitive impairment resulting in inability to comply with treatment instructions
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006925


Contacts
Layout table for location contacts
Contact: Emmanuel During, MD 6507217561 eduring@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94306
Contact: Emmanuel During    650-721-7561    eduring@stanford.edu   
Sponsors and Collaborators
Stanford University
Jazz Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Emmanuel During, MD Stanford University

Publications:
Layout table for additonal information
Responsible Party: Emmanuel During, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04006925    
Other Study ID Numbers: 47852
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Emmanuel During, Stanford University:
sodium oxybate
Additional relevant MeSH terms:
Layout table for MeSH terms
REM Sleep Behavior Disorder
Mental Disorders
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs