Clinical trial · Interventional
Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia
A Study Evaluating Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia. A Phase III Double-blind Randomized Placebo-controlled Trial
NCT02363075CI-TRIAL-00023883DXAunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamfetamine sulphate | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dexamfetamine sulphate
- description
- Dexamfetamine Sulphate 5 mg Tablets
- interventionNames
- Drug: Dexamfetamine sulphate
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Aspect tablets identical to the active
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Multidimensional Fatigue inventory - MFI 20 scale score
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.