Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis

NCT01879202 | Unknown Phase 2 DMC

• 1 other identifier: SSP
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is a common symptom in multiple sclerosis (MS) that is characterized by physical and/or mental exhaustion. Fatigue is difficult to treat and treatment efficacy of available therapy is limited. The goal of this study is to determine whether MS-associated fatigue improves after 6 weeks of methylphenidate therapy. Treatment efficacy will be measured by a questionnaire called "Fatigue Severity Scale" (FSS).

Conditions

Multiple Sclerosis; Fatigue

Keywords

multiple sclerosis; fatigue; fatigue severity scale; fatigue impact scale; quality of life

Outcome Measures

Primary Outcomes (1)

• Change of Fatigue as measured by Fatigue Severity Scale

  The Fatigue severity scale is one of the most commonly used self questionnaires to measure fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. A low value (e.g., 1); indicates strong disagreement with the statement, whereas a high value (e.g., 7); indicates strong agreement. A total score of 36 or more suggests presence of fatigue.

  Baseline versus follow-up at 6 weeks

Secondary Outcomes (1)

• Change of Fatigue as measured by Modified Fatigue Impact Scale (MFIS)

  Baseline versus follow up at 6 weeks

Other Outcomes (4)

• Change of Quality of life as assessed by Hamburger Lebensqualitätsfragebogen (HAQUAMS)

  Baseline versus follow up at 6 weeks

• Fatigue as measured by TAP (Test for Attentional Performance)

  Baseline, after 6 weeks

• Quality of sleep as measured by Epworth Sleepiness Scale (ESS)

  Baseline, after 6 weeks

Study Arms (2)

Methylphenidate modified release

ACTIVE COMPARATOR

The active agents is racemic methylphenidate hydrochloride, modified release, a mild central nervous system stimulant (pharmacotherapeutic group: psychostimulants). Study medication will be taken once daily. Initially patients will be provided with 20mg and 30mg capsules of study medication. They are instructed to take 20mg within the first week and within the second week 30mg capsules. Visit 2 is scheduled two weeks after baseline and at Visit 2 patients will be provided with 40mg capsules and instructed to take them for the rest of the study.

Drug: Methylphenidate modified release

Maltodextrin

PLACEBO COMPARATOR

Study medication has to be taken once daily. Initially patients will be provided with 20mg and 30mg capsules of study medication. They are instructed to take 20mg within the first week and within the second week 30mg capsules. Visit 2 is scheduled two weeks after baseline and at Visit 2 patients will be provided with 40mg capsules and instructed to take them for the rest of the study.

Drug: Maltodextrin

Interventions

Methylphenidate modified release DRUG

Ritalin 20mg once daily within the first week, Ritalin 30mg once daily within the second week and afterwards Ritalin 40mg will be taken once daily throughout the remaining active treatment phase.

Also known as: Ritalin LA 20mg, Ritalin LA 30mg, Ritalin LA 40mg

Methylphenidate modified release

Maltodextrin DRUG

Study medication will be taken once daily. Patients will take 20mg of study medication within the first week, 30mg within the second week and afterwards 40mg of study medication throughout the remaining active study period.

Also known as: Placebo

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of multiple sclerosis according to McDonalds criteria.
• Age \> 18 years
• Fatigue as measured by Fatigue Severity Scale
• Signed informed consent

You may not qualify if:

• Known allergy or hypersensitivity to Methylphenidate or any of its ingredients
• Marked anxiety, tension and agitation
• Patients with glaucoma or hyperthyroidism
• Patients with motor-tics, a family history or diagnosis of Tourette´s syndrome
• Treatment with monoamine oxidase inhibitors, also within a minimum of 14 days following discontinuation (hypertensive crisis may result).
• Phaeochromocytoma
• Pre-existing cardiovascular disorders including severe hypertension, angina, arterial occlusive disorder, heart failure, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies.
• History of drug dependence or alcoholism
• History of seizures
• Pregnant women or females of childbearing potential who want to become pregnant within the study period.
• Severe psychiatric disorders
• Change of any medication treatment \<8 weeks before starting the study
• Participation in any other clinical trial at the same time

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Neurology

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Methylphenidate; maltodextrin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fritz Leutmezer, MD

  Medical University of Vienna, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fritz Leutmezer, MD

CONTACT

+43 1 40400; fritz.leutmezer@meduniwien.ac.at

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: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: June 17, 2013
• Study Start: December 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

AU (1)