Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to estimate the efficiency at 3 months of dexamfetamine sulphate on the MFI 20 scale in severe fatigue of patients with stabilized gliomas.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Dextroamphetamine

Criteria

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