NCT01279876

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

3.3 years

First QC Date

January 18, 2011

Last Update Submit

August 12, 2015

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (4)

  • Number of relapses

    one year

  • EDSS

    Expanded Disability Status Scale reported by a neurologist

    one year (every 3 months)

  • PASAT-3 score

    Paced Auditory Serial Addition Test 3seconds score

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

  • proportion of brain gray matter volume to intracranial volume

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

Secondary Outcomes (1)

  • MSFC score

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

Study Arms (2)

Melatonin

ACTIVE COMPARATOR
Drug: Melatonin

Placebo

PLACEBO COMPARATOR
Drug: Melatonin

Interventions

MelatoninDRUG

3mg oral, daily, one hour before sleep

MelatoninPlacebo

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iranian Center for Neurological Researches, Imam Khomeini Hospital

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Mohammad Hossein Harirchian, M.D.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

October 1, 2010

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations

IR(1)