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The effects of lisdexamphetamine dimesylate on multiple sclerosis patients with fatigue

The effects of lisdexamphetamine dimesylate on multiple sclerosis patients with fatigue: A randomized, double blind, placebo-control clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241129063892N2
Enrollment
50
Registered
2024-12-21
Start date
2024-11-18
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue in multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group: For patients, the drug Lysdexamfetamine dimesylate is initially started at a dose of 30 mg daily, and then, if the patient tolerates it, it is increased by 20 mg ev

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults with multiple sclerosis according to the McNeeshan 2017 criteria EDSS less than 5.5 MIFS>33 according to the Fatigue criterion.

Exclusion criteria

Exclusion criteria: Severe depression Hypothyroidism Severe anemia (Hb‹ 9 g/dl) Breastfeeding or pregnancy History of ischemic cerebrovascular accident or cardiovascular disease Decreased kidney function Presence of an MS attack within the past month Uncontrolled blood pressure (blood pressure = 160/100 mm Hg) Concomitant use of medications that affect fatigue History of drug, psychotropic, and alcohol abuse Concomitant use of monoamine oxidase inhibitors and serotonin reuptake inhibitors Presence of narcolepsy The presence of psychosis History of seizures History of vascular disorders

Design outcomes

Primary

MeasureTime frame
Fatigue. Timepoint: Beginning of study, weeks 4, 6, 8. Method of measurement: Kurtzke Functional Systems Scores) MSFC,FSS( ? PSQI? MFI?SF-36 ? Fatigue Severity Scale (FSS) of Sleep Disorders ? HADS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyad Mohammad Baghbanian

Mazandaran University of Medical Sciences

Mohammadbaghbanian@gmail.com+98 11 3334 3014

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026