Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

Herlev Hospital

Status and phase: Terminated; Phase 3

Conditions: Post Stroke Fatigue; Stroke

Treatments: Drug: modafinil; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01800097

ModaA001

Details and patient eligibility

About

This study is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining attention and faster reaction times. The cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and better physical performances due to a higher level of physical activity.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age and stroke within 14 days
• Modified Rankin Scale 3 or under and Barthel 85 or over before stroke
• Person that can understand instruction and do tests and questionnaires on their own or with support
• has given informed consent
• MFI-20 score of 12 or more
• Infertile person or fertile women tested negative of pregnancy and using safe anticonception

Exclusion criteria

• Dementia or other neuropsychiatric disease making the person incapable of understanding instructions
• Other disease with fatigue as a known symptom
• stroke induced by trauma, infection or surgical procedure
• former drug abuse
• known contraindication to treatment with modafinil
• known active malignancy, benign intracranial tumor, subdural or epidural bleeding
• kidneydysfunction with creatinin more than 265 micromol/L or liver disease with ASAT (aspartate aminotransferase) elevated to more than 70 U/L for women or 100 U/L for men.
• allergy to project treatment
• use of benzodiazepin or antiepileptic drugs in a fixed dose. Sleeping pills not included.
• Patients threaded with ciclosporin or anti HIV medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

41 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo

Modafinil

Active Comparator group

Description:

Modafinil

Treatment:

Drug: modafinil