E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
fatigue in low-grade glioma patients |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Investigating the influence of modafinil on fatigue, cognitive functioning, and quality of life of LGG patients. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | 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). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |