Multiple SclerosisNCT04035889
Melatonin for Sleep in MS
A study testing Melatonin in people with Multiple Sclerosis, run by University of California, San Francisco at 1 site in United States.
Trial summary
Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 17 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-70 with a diagnosis of MS by 2010 McDonald Criteria or CIS (clinically isolated syndrome), who report sleep disturbance as measured by a score >=5 on the Pittsburgh Sleep Quality Index, or more specific insomnia symptoms (a score of >14 on the Insomnia Severity Index) over the past month.
- Participants must be able to read and write English
Who cannot join
- Individuals with nocturnal asthma, use of melatonin or another sleep agent in the past 2 weeks, women attempting conception, relapse or steroids or infusible disease modifying therapies (DMTs) in prior month.
- Non-English speaking individuals
- Individuals with hypertension, impaired liver function, or seizure disorder
- Individuals with untreated depression, as determined by a score greater than or equal to 8 points on the HADS (Hospital Anxiety and Depression Scale)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: A Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)
Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Altered melatonin regulation and signaling has been implicated in MS, through observations including (1) MS risk associated with shift work, (2) contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration.
To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized controlled pilot trial.
- Conditions
- Multiple Sclerosis
- Being tested
- Melatonin, Placebo
- Keywords
- Sleep, Melatonin, Sleep disturbance
- Medical subject headings
- Multiple Sclerosis, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Participants will start with 0.5 mg tablets of melatonin with the option of switching to an 'escalation dose' of 3 mg if no relief after 3 days.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo Receives: Dietary Supplement: Melatonin; Dietary Supplement: Placebo |
| Group 2 | Experimental | Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin. Receives: Dietary Supplement: Melatonin; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep time
Total sleep time (time in bed spent sleeping after "lights off")
Measured: 4 weeks
Sleep quality
Sleep quality and sleep disturbances assessed by the Pittsburgh Sleep Quality Index and Insomnia Severity Index
Measured: 4 weeks
Secondary outcomes (1)
Sleep efficiency
Sleep efficiency: % time asleep while in bed after "lights off", averaged for mean nightly sleep efficiency
Sleep onset latency time: time from "lights off" to sleep
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start23 Sep 2019
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riley Bove, MD, University of California, San Francisco
- Investigators
- Riley Bove, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035889
- Sponsor's protocol ID
- 19-27108
- Status last verified
- Jan 2021
- First submitted
- 25 Jul 2019
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT04035889
- Acronym / sponsor ID
- 19-27108
- Conditions
- Multiple Sclerosis
- Keywords
- Sleep, Melatonin, Sleep disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Altered melatonin regulation and signaling has been implicated in MS, through observations including (1) MS risk associated with shift work, (2) contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration.
To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized controlled pilot trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Melatonin, Dietary Supplement: PlaceboParticipants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo |
| Group 2 | Experimental | Dietary Supplement: Melatonin, Dietary Supplement: PlaceboParticipants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 20-70 with a diagnosis of MS by 2010 McDonald Criteria or CIS (clinically isolated syndrome), who report sleep disturbance as measured by a score >=5 on the Pittsburgh Sleep Quality Index, or more specific insomnia symptoms (a score of >14 on the Insomnia Severity Index) over the past month.
- Participants must be able to read and write English
Key exclusion criteria (4 listed)
- Individuals with nocturnal asthma, use of melatonin or another sleep agent in the past 2 weeks, women attempting conception, relapse or steroids or infusible disease modifying therapies (DMTs) in prior month.
- Non-English speaking individuals
- Individuals with hypertension, impaired liver function, or seizure disorder
- Individuals with untreated depression, as determined by a score greater than or equal to 8 points on the HADS (Hospital Anxiety and Depression Scale)
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 |
|---|---|---|
| MelatoninParticipants will start with 0.5 mg tablets of melatonin with the option of switching to an 'escalation dose' of 3 mg if no relief after 3 days. | Dietary supplement | Group 1, Group 2 |
| PlaceboPlacebo | Dietary supplement | Group 1, Group 2 |
Primary outcome
Sleep time
Time frame: 4 weeks
Total sleep time (time in bed spent sleeping after "lights off")
Sleep quality
Time frame: 4 weeks
Sleep quality and sleep disturbances assessed by the Pittsburgh Sleep Quality Index and Insomnia Severity Index
1 secondary outcome
Sleep efficiency
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- 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.
Riley Bove, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Multiple Sclerosis, run by University of California, San Francisco 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 2 inclusion and 4 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 19 Jan 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep time (time frame: 4 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?
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 19 Jan 2021.