Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients

CompletedPhase 2Relapsing MSNCT01279876

What it found

No results found

We found no results in the registry or in papers.

This trial finished 12 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

What it measured

Main measures

  • Number of relapses

    one year

    Relapses
  • EDSS

    one year (every 3 months)

    Disability progression
  • PASAT-3 score

    one year (at the beginning and end of the year)

    Thinking and memory
  • proportion of brain gray matter volume to intracranial volume

    one year (at the beginning and end of the year)

    Brain volume loss

Other measures (1)

  • MSFC score

    one year (at the beginning and end of the year)

    Disability progressionThinking and memory

Who could take part

Relapsing MS · 20 to 45

Show the full criteria

Inclusion criteria

* definite diagnosis of relapsing-remitting multiple sclerosis * EDSS \<=5 * at least 6months consumption of interferon beta 1a

Exclusion criteria

* illiteracy * evidence of Nystagmus or visual acuity lower than 5/10 in each of the eyes * relapse in the last 3 months * pregnancy or deciding to become pregnant during the following year * regulatory consumption of warfarin, nifedipine, nonsteroidal anti-inflammatory drugs (NSAIDs), beta-blockers, fluvoxamine, isoniazide, progestin * history of epilepsy, stroke, major depression, endocrine, hepatic, hematologic, and nephrologic diseases

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 is to determine whether melatonin is effective in the treatment of relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying drugs.

Papers

    Loading reviews and guidelines…

    Related trials

    History

      1. Started

        Oct 2010

      2. Main results due

        Jan 2014

      3. Finished

        Feb 2014

      Assembled by software from public sources.