Effect of Melatonin on Multiple Sclerosis Related Fatigue

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Fatigue

Treatments: Drug: Placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01718678

ASD-12111

Details and patient eligibility

About

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.

Full description

Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS

Enrollment: 44 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups, including a placebo group

Melatonin

Active Comparator group

Description:

Melatonin, Tablet, 3 mg, once, one month

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Description:

Placebo, tablet

Treatment:

Drug: Placebo