Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis

CompletedPhase 2Relapsing MSNCT01718678

What it found

No results found

We found no results in the registry or in papers.

This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Melatonin

    Melatonin receptor agonist

Placebo

  • Placebo

What it measured

Main measures

  • Fatigue

    at one month after treatment

    Thinking and memoryFatigue

Other measures (1)

  • Quality Of Life

    at one month after treatment

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 55

Show the full criteria

Inclusion criteria

1. definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria 2. a baseline of Expanded Disability Status Score (EDSS)of less than 5.0 3. aged between 18 and 55 years of either sex 4. treated with one type of interferon beta-1a (IFNB-1a); 5. signed an informed consent

Exclusion criteria

1. clinical relapsing of MS during past 30 days; 2. use of melatonin and warfarin within 30 days prior to participation; 3. concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS, aspirin ; 4. working more than one nighttime shift per month; 5. Pregnancy or lactation; 6. history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ; 7. failure to adhere to the study protocol

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment of fatigue and Quality of Life of MS patients.

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History

    1. Started

      May 2012

    2. Main results due

      Oct 2012

    3. Finished

      Oct 2012

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