REM Sleep Behavior DisorderPhase 4NCT04006925

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

A Phase 4 study testing Sodium Oxybate in people with REM Sleep Behavior Disorder and Parkinson Disease, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: REM Sleep Behavior Disorder, Parkinson Disease
What is being tested?: Sodium Oxybate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2019to 1 Feb 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Palo Alto, California, 94306

Other trials in United States

About this study

Official title: Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial

Read the 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.

Conditions: REM Sleep Behavior Disorder, Parkinson Disease
Being tested: Sodium Oxybate, Placebo
Keywords: sodium oxybate
Medical subject headings: REM Sleep Behavior Disorder, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium OxybateDrug
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").
PlaceboOther
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.

Study groups in NCT04006925
Study group	Role	What they receive
Sodium Oxybate (SXB) arm	Active comparator	Sodium Oxybate (SXB) will be dispensed to the participants. Receives: Drug: Sodium Oxybate
Placebo (PBO) arm	Placebo comparator	Placebo will be dispensed to the participants. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)
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):
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).
The number of injurious (severe) episodes is reported.
Measured: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)

Secondary outcomes (5)

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."
Measured: Assessed at week 12 (end of treatment period).
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."
Measured: Assessed at week 12 (end of treatment period).
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.
Measured: Assessed at baseline and week 12
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.
Measured: Assessed at baseline and week 12 (average approximately 8 hours to assess at each time point)
Change in Ambulatory Measures of Movements During Sleep Using Actigraphy
Measure of "activity score" using in-home 4-week actigraphy
Measured: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 20191 Feb 2022

First posted5 Jul 2019
Study start10 Sep 2019
Primary completion1 Feb 2022
Study completion1 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, double-blind, placebo-controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04006925
Sponsor's protocol ID: 47852
Status last verified: Apr 2023
First submitted: 27 Jun 2019
Last updated: 10 May 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19483483
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.
PubMed 26595534
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.
PubMed 28366329
During EH, Hernandez B, Miglis MG, Sum-Ping O, Hekmat A, Cahuas A, Ekelmans A, Yoshino F, Mignot E, Kushida CA. Sodium oxybate in treatment-resistant rapid-eye-movement sleep behavior disorder. Sleep. 2023 Aug 14;46(8):zsad103. doi: 10.1093/sleep/zsad103.
PubMed 37052688

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All REM Sleep Behavior Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT04006925
Acronym / sponsor ID: 47852
Conditions: REM Sleep Behavior Disorder, Parkinson Disease
Keywords: sodium oxybate
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Jazz Pharmaceuticals
Study start: 10 Sep 2019 (actual)
Primary completion: 1 Feb 2022 (actual)
Study completion: 1 Feb 2022 (actual)
First posted: 5 Jul 2019 (actual)
Results: Posted 10 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, double-blind, placebo-controlled trial

Arm	Type	Receives
Sodium Oxybate (SXB) arm	Active comparator	Drug: Sodium OxybateSodium Oxybate (SXB) will be dispensed to the participants.
Placebo (PBO) arm	Placebo comparator	Other: PlaceboPlacebo will be dispensed to the participants.

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium OxybateSodium 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").	Drug	Sodium Oxybate (SXB) arm
PlaceboPlacebo 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.	Other	Placebo (PBO) arm

Primary outcome

Number of RBD Episodes in One Month (Per Patient RBD Log)
Time frame: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)
Patients record any episode of dream enactment, such as talking, shouting, kicking, or punching, etc.
Number of Severe of RBD Episodes in One Month (Per Patient RBD Log)
Time frame: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)
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). The number of injurious (severe) episodes is reported.

5 secondary outcomes

Number of Responders According to the CGI Efficacy Scale (CGI-E)
Time frame: Assessed at week 12 (end of treatment period).
Number of Responders According to the CGI Improvement Scale (CGI-I)
Time frame: Assessed at week 12 (end of treatment period).
Epworth Sleepiness Scale (ESS) Score
Time frame: Assessed at baseline and week 12
RBD Episode Severity and Frequency During REM Sleep by Quantitative Video-PSG (Polysomnography) Analysis Per 10 Minutes of REM Sleep
Time frame: Assessed at baseline and week 12 (average approximately 8 hours to assess at each time point)
Change in Ambulatory Measures of Movements During Sleep Using Actigraphy
Time frame: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)

Results and safety

Results posted to the registry on 10 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sodium Oxybate (SXB) Arm	12	10
Placebo (PBO) Arm	12	12

Primary outcome: Number of RBD Episodes in One Month (Per Patient RBD Log)

Time frame: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks). Median (Inter-Quartile Range). Unit: episodes

Measure	Sodium Oxybate (SXB) Arm n = 12	Placebo (PBO) Arm n = 12
Baseline	37.5 (27.5 to 48.5)	35.0 (28.5 to 45.5)
Final dose	23.5 (6.0 to 47.0)	25.5 (14.5 to 46.0)

Sodium Oxybate (SXB) Arm: Median Difference (Net): -23.5 (95% CI -41.0 to -2.0), p = 0.03, Wilcoxon Signed Rank test
Placebo (PBO) Arm: Median Difference (Net): -9.0 (95% CI -21.5 to 0.0), p = 0.11, Wilcoxon Signed Rank test
Sodium Oxybate (SXB) Arm vs Placebo (PBO) Arm: Median Difference (Net): -14.5 (95% CI -32.0 to 11.3), p = 0.27, Mann Whitney U test

Population analysed: Participants with data at each time point are included in the analysis

Primary outcome: Number of Severe of RBD Episodes in One Month (Per Patient RBD Log)

Time frame: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks). Median (Inter-Quartile Range). Unit: episodes

Measure	Sodium Oxybate (SXB) Arm n = 12	Placebo (PBO) Arm n = 12
Baseline	1.5 (0.5 to 4.0)	1.5 (0.0 to 3.5)
Final dose	0.5 (0.0 to 1.0)	1.0 (0.0 to 2.5)

Sodium Oxybate (SXB) Arm: Median Difference (Net): -1.0 (95% CI -3.0 to 0.0), p = 0.02, Wilcoxon Signed Rank test
Placebo (PBO) Arm: Median Difference (Net): 0.0 (95% CI -1.0 to 1.0), p = 0.83, Wilcoxon Signed Rank test
Sodium Oxybate (SXB) Arm vs Placebo (PBO) Arm: Median Difference (Net): -1.0 (95% CI -3.5 to 0.0), p = 0.09, Mann Whitney U test

Population analysed: Participants with data at each time point are included in the analysis

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sodium Oxybate (SXB) Arm	5 of 12 (41.7%)	7 of 12 (58.3%)	0 of 12
Placebo (PBO) Arm	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19483483Shneerson 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.
Background: PubMed 26595534Liebenthal 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.
Background: PubMed 28366329Moghadam 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.
Derived from this study: PubMed 37052688During EH, Hernandez B, Miglis MG, Sum-Ping O, Hekmat A, Cahuas A, Ekelmans A, Yoshino F, Mignot E, Kushida CA. Sodium oxybate in treatment-resistant rapid-eye-movement sleep behavior disorder. Sleep. 2023 Aug 14;46(8):zsad103. doi: 10.1093/sleep/zsad103.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emmanuel During, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sodium Oxybate in people with REM Sleep Behavior Disorder and Parkinson Disease, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of RBD Episodes in One Month (Per Patient RBD Log) (time frame: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04006925, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.