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Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Melatonin
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iranian Center for Neurological Researches, Imam Khomeini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of relapses
EDSS
Expanded Disability Status Scale reported by a neurologist
PASAT-3 score
Paced Auditory Serial Addition Test 3seconds score
proportion of brain gray matter volume to intracranial volume

Secondary Outcome Measures

MSFC score
Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score)

Full Information

First Posted
January 18, 2011
Last Updated
August 12, 2015
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01279876
Brief Title
Melatonin in Relapsing-Remitting Multiple Sclerosis Patients
Official Title
Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous system, and the major cause of disability in the youngsters all over the world, still with no definitely known etiology and treatment. Melatonin is a hormone secreted by pineal gland famous for its role in circadian rhythm regulation, and with known antioxidant effects. It was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in comparison to other diseases and is correlated with the Multiple Sclerosis Functional Composite score of the patients. Melatonin is also suggested to have an immunomodulatory role. Therefore, we hypothesize that melatonin can be effective in the treatment of relapsing-remitting multiple sclerosis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
3mg oral, daily, one hour before sleep
Primary Outcome Measure Information:
Title
Number of relapses
Time Frame
one year
Title
EDSS
Description
Expanded Disability Status Scale reported by a neurologist
Time Frame
one year (every 3 months)
Title
PASAT-3 score
Description
Paced Auditory Serial Addition Test 3seconds score
Time Frame
one year (at the beginning and end of the year)
Title
proportion of brain gray matter volume to intracranial volume
Time Frame
one year (at the beginning and end of the year)
Secondary Outcome Measure Information:
Title
MSFC score
Description
Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score)
Time Frame
one year (at the beginning and end of the year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Hossein Harirchian, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iranian Center for Neurological Researches, Imam Khomeini Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

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