Melatonin for Sleep in MS

NCT ID: NCT04035889

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2020-11-17

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

Participants assigned to Group 1 will take 2 weeks of melatonin followed by 2 weeks of placebo

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_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.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Group 2

Participants assigned to Group 2 will take 2 weeks of placebo followed by 2 weeks of melatonin.

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_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.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

Melatonin

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Riley Bove, MD

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Riley Bove, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

19-27108

Identifier Type: -

Identifier Source: org_study_id