NCT01718678

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 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

May 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

5 months

First QC Date

October 28, 2012

Last Update Submit

October 30, 2012

Conditions

Fatigue

Keywords

Multiple sclerosisMelatoninFatigueQuality of life

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Modified Fatigue Impact Scale (MFIS)is a21-item (score range of each item: 0-4) questionnaire with the total score computed from 0 (no impact of fatigue) to 84 (maximum impact of fatigue) in three subscales containing: physical (9 items), cognitive (10 items) and psychosocial (2 items) aspects.

    at one month after treatment

Secondary Outcomes (1)

  • Quality Of Life

    at one month after treatment

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

Melatonin, Tablet, 3 mg, once, one month

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo, tablet

Drug: Placebo

Interventions

MelatoninDRUG

it is kind of drug

Melatonin
PlaceboDRUG

It is Placebo

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, 7007, Iran

Location

MeSH Terms

Conditions

FatigueMultiple Sclerosis

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsDemyelinating 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 Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

October 28, 2012

First Posted

October 31, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

IR(1)