Modafinil and Exercise for Post Stroke Fatigue

NCT06354985 | Not Yet Recruiting Phase 3 DMC

• 4 other identifiers: 23-5996MODEX2023FRN:183960CTO Project ID: 4701
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

Brief Summary

A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke. Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has the following aim: 1\. Test if Exercise plus Modafinil is better than Exercise plus a Sugar Pill This study will take place at up to 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels. Participants will be assigned at random (like flipping a coin) to 1 of 2 groups:

1. 1.Sugar Pill plus Exercise
2. 2.Modafinil plus Exercise

Conditions

Stroke; Fatigue; Modafinil; Exercise

Outcome Measures

Primary Outcomes (1)

• Severity of Fatigue Symptoms

  Multidimensional Fatigue Inventory

  Week 8

Secondary Outcomes (10)

• Severity of Fatigue Symptoms

  Week 4 and 26

• Impact on Quality of Life

  Week 8 and 26

• Walking Recovery

  Week 8 and 26

• Leg Strength and Coordination

  Week 8 and 26

• 3-Day Physical Activity Assessment

  Week 8

Study Arms (2)

Placebo Drug + Exercise

PLACEBO COMPARATOR

Placebo Drug + Exercise for 8 weeks.

Drug: Placebo; Behavioral: Exercise

Modafinil 200 mg/day + Exercise

ACTIVE COMPARATOR

Modafinil 200 mg/day + Exercise for 8 weeks.

Drug: Modafinil 200mg; Behavioral: Exercise

Interventions

Modafinil 200mg DRUG

Modafinil 200mg daily for 8 weeks.

Also known as: Modafinil

Modafinil 200 mg/day + Exercise

Placebo DRUG

Placebo daily for 8 weeks.

Also known as: Sugar Pill

Placebo Drug + Exercise

Exercise BEHAVIORAL

Exercise three times per week for 8 weeks.

Modafinil 200 mg/day + Exercise; Placebo Drug + Exercise

Eligibility Criteria

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

You may qualify if:

• \>18 years of age (on date of consent)
• \>3 months post stroke onset (i.e. intracerebral hemorrhage or ischemic stroke diagnosed by a physician) (on date of consent)
• evidence of stroke on computed tomography (CT) or magnetic resonance imaging (MRI)
• disabling post stroke fatigue as measured by Multidimensional Fatigue Inventory score \>60
• Modified Rankin disability score \<4
• Able to participate in moderate exercise for an hour (with one person assistance or less)

You may not qualify if:

• contraindications to Modafinil
• on stimulant medications already
• subarachnoid hemorrhage
• impaired comprehension or language impairment that prevents following visual or pictograph adapted instructions or providing informed consent
• severe motor impairment or inability to participate in the exercise
• unable to participate in exercise due to musculoskeletal complaints, unstable heart failure, or renal disease
• untreated hypothyroidism or anemia
• cancer likely to result in death in \<6 months
• severe depression requiring therapy as indicated by suicidal ideation and/or Depression Anxiety Stress Scales (DASS) depression sub-score \>20
• currently enrolled in a structured exercise program
• untreated severe sleep apnea with an Apnea/Hypopnea index \>30 as measured by validated wearable sleep apnea detector
• pregnant, breastfeeding, or positive test for pregnancy at baseline

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Stroke; Fatigue; Motor Activity

Interventions

Modafinil; Sugars; Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark Bayley, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josie Chundamala, MA, CCRP

CONTACT

416-597-7015; josie.chundamala@uhn.ca

Olga Yaroslavtseva

CONTACT

416-597-7015; olga.yaroslavtseva@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All members of the research team and the participants will be blinded to medication group allocation. The study statistician who is unblinded and the Data Safety Monitoring Board will have access to the medication assignment if needed (e.g. adverse drug reaction).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 9, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share