Overview

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