Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2016
• Main ID: NCT02363075
• Date of registration: 09/02/2015
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia DXA
• Scientific title: A Study Evaluating Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia. A Phase III Double-blind Randomized Placebo-controlled Trial
• Date of first enrolment: April 2013
• Target sample size: 58
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02363075
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Florence LAIGLE-DONADEY, MD

• Name: Florence LAIGLE-DONADEY, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

• Name: Florence LAIGLE-DONADEY, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Glioma

Intervention(s)

Drug: placebo

Drug: Dexamfetamine sulphate

Primary Outcome(s)

Multidimensional Fatigue inventory - MFI 20 scale score [Time Frame: 3 months]

Secondary ID(s)

P110501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors