Clinical Trial Details
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NCT02363075 : Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia
PhasePhase 3
AgesMin: 18 Years Max: N/A
Inclusion criteria :

- Patients complaining of a severe asthenia defined as a MFI 20 score ? 60/100

- Patients suffering from histologically proven gliomas

- Patients with responsive or stable disease (according to RANO criteria) for at least 3
months, either still on chemotherapy or only being under simple surveillance

- stable dosage of steroids for at least 1 week

- Time elapsed post-radiotherapy more than 3 months

- HAD score of depression ?8

- Karnofsky performance index ? 60

- ? 18 years of age

- contraceptive measures

- written informed consent

- Depending from the french system of health assurance

Exclusion criteria :

- Severe aphasia or other symptoms compromising the tests execution

- concomitant uncontrolled pathology

- Known symptomatic or constitutional cardiovascular disease, (cardiac arrhythmia,
recent myocardial infarction, chest pain, history of unstable angina) and/or
uncontrolled hypertension, (? 16/10), arteriosclerosis, cardiac abnormality detected
at the initial cardiac echography.

- Hyperthyroidism

- Known hypersensitivity to dexamphetamine or related compounds

- Glaucoma

- Porphyria

- Hemoglobin level of less than 10,0 g/dL

- Alcohol or drug abuse,

- Agitation

- Tourette's syndrome

- Patients who have been receiving MAO inhibitors during the past 14 days

- Hereditary hypersensitivity to galactose, Lapp lactase deficiency or glucose-galactose
malabsorption syndrome

- Hereditary hypersensitivity to saccharose, glucose-galactose malabsorption syndrome or
saccharase-isomaltase deficiency

- Pregnant or lactating woman

- Non french speaker

- History of psychiatric disorder
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