The effect of modafinil on fatigue, cognition and functional connectivity in low-grade glioma patients: a double-blind randomized trial. - modafinil in LGG patients
- Conditions
- fatigue in low-grade glioma patients
- Registration Number
- EUCTR2007-003102-10-NL
- Lead Sponsor
- fonds NutsOhra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
(1) reported severe fatigue (score > 35) on the Checklist Individual Strength (CIS), (2) histologically confirmed LGG without signs of tumor recurrence in the last year, and (3) written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
(1) history of chemotherapy treatment, (2) anti-tumor treatment other than antiepileptic drugs (e.g. chemotherapy, radiotherapy, corticosteroids), (3) psychiatric disease or symptoms, (4) insufficient mastery of the Dutch or English language, (5) inability to communicate adequately.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method