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The effect of modafinil on fatigue, cognition and functional connectivity in low-grade glioma patients: a double-blind randomized trial. - modafinil in LGG patients

The effect of modafinil on fatigue, cognition and functional connectivity in low-grade glioma patients: a double-blind randomized trial. - modafinil in LGG patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003102-10-NL
Enrollment
Unknown
Registered
2008-07-11
Start date
2009-01-23
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

fatigue in low-grade glioma patients

Interventions

Trade Name: Modiodal Product Name: Modiodal Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

fonds NutsOhra
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Investigating the influence of modafinil on fatigue, cognitive functioning, and quality of life of LGG patients. ;Secondary Objective: Assessing the correlation between (changes in) fatigue, cognition, and quality of life on one hand, and functional connectivity in the brain on the other hand.;Primary end point(s): The CIS will be used as main study parameter, as a measure of fatigue. Quality of Life will be assessed by means of the SF-36, BCM20, and MOS. The CES-D will be administered to investigate levels of depression. A neuropsychological test battery assessing a range of cognitive functions will be administered. MEG recordings will take place during resting state, which means no-task and eyes-closed; analyses will be done with synchronization likelihood. Assessment of all parameters will take place at baseline (pretreatment; t0), t1 (immediately after six weeks of first treatment with placebo or modafinil) and t2 (immediately after six weeks of second treatment with placebo or modafinil).—

Countries

Netherlands

Outcome results

None listed

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