GliomaPhase 3DXANCT02363075
Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia
A Phase 3 study testing Dexamfetamine sulphate in people with Glioma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Dexamfetamine sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jan 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Karnofsky performance index ≥ 60
- ≥ 18 years of age
- contraceptive measures
- written informed consent
- Depending from the french system of health assurance
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Florence LAIGLE-DONADEY, MD contact
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Pitie Salpetriere
Paris, 75013
Florence LAIGLE-DONADEY, MD
About this study
Official title: A Study Evaluating Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia. A Phase III Double-blind Randomized Placebo-controlled Trial
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.
Read the detailed description
Quality of life of patients with stabilized gliomas is often impacted by a severe physical and psychological fatigue resulting from both tumor and side effects of treatments.
It is a randomized double blind Placebo-Controlled Trial evaluating the effect of dexamfetamine sulphate on severe fatigue in glioma patients. Half of the participants will receive dexamfetamine sulphate and the other half will receive a placebo. Neither the participant nor the study doctor will know what group they are in.
The main objective is to assess the impact at 3 months of dexamfetamine sulphate in patients suffering from a RANO stable or responsive glioma complaining of a severe fatigue (quantified by the Multidimensional Fatigue inventory - MFI 20 scale).
The secondary objectives include: evaluation of side effects, quality of life, cognitive functions, depression, variation in time of both fatigue scales MFI 20 and VAS.
58 patients will be included. In patients complaining of severe asthenia, with a non progressive neuro-oncological disease, and without criteria of depression revealed by HAD (Hospital Anxiety and Depression) scale, evaluation of fatigue will be done with the MFI 20 scale. Patients with a MFI 20 score ≥60/100 and corresponding to inclusion criteria will be invited to participate.
After randomisation, a baseline evaluation will be done, including MFI20, Norris VAS, EORTC QLQ-C30, Mattis scale, Trail Making Test, Grober and Buschke, Wisconsin Card Sorting Test , HAD scale and Marin scale.
Patients will receive, in a double blinded way, six pills a day either of dexamphetamine sulfate (15 mg*2) or of placebo, during 3 months, after an initial phase of progressive increasing levels of dose every 10 days, depending on tolerance.
The evaluation of fatigue, quality of life will be done every month during the 3 months of treatment. The cognitive evaluation will be done at 3 months.
The main criteria of evaluation is the variation during 3 months of the MFI 20 score in non progressive patients.
- Conditions
- Glioma
- Being tested
- Dexamfetamine sulphate, placebo
- Keywords
- dexamfetamine sulphate, severe asthenia, glioma, MFI-20, double-blind, stabilisation phase
- Medical subject headings
- Glioma, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamfetamine sulphateDrug
10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.
placeboDrug
10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.
| Study group | Role | What they receive |
|---|---|---|
| Dexamfetamine sulphate | Experimental | Dexamfetamine Sulphate 5 mg Tablets Receives: Drug: Dexamfetamine sulphate |
| placebo | Placebo comparator | Aspect tablets identical to the active Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Fatigue inventory - MFI 20 scale score
improvement of the MFI 20 score between the inclusion and the evaluation at 3 months in case of non progressive disease during this period of time.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startApr 2013
- Primary completionJul 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence LAIGLE-DONADEY, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363075
- Sponsor's protocol ID
- P110501
- Acronym
- DXA
- Status last verified
- Aug 2016
- First submitted
- 9 Feb 2015
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Dexamfetamine Sulphate in Patients With Glioma Suffering From Severe Asthenia. A Phase III Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02363075
- Acronym / sponsor ID
- DXA / P110501
- Conditions
- Glioma
- Keywords
- dexamfetamine sulphate, severe asthenia, glioma, MFI-20, double-blind, stabilisation phase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Quality of life of patients with stabilized gliomas is often impacted by a severe physical and psychological fatigue resulting from both tumor and side effects of treatments.
It is a randomized double blind Placebo-Controlled Trial evaluating the effect of dexamfetamine sulphate on severe fatigue in glioma patients. Half of the participants will receive dexamfetamine sulphate and the other half will receive a placebo. Neither the participant nor the study doctor will know what group they are in.
The main objective is to assess the impact at 3 months of dexamfetamine sulphate in patients suffering from a RANO stable or responsive glioma complaining of a severe fatigue (quantified by the Multidimensional Fatigue inventory - MFI 20 scale).
The secondary objectives include: evaluation of side effects, quality of life, cognitive functions, depression, variation in time of both fatigue scales MFI 20 and VAS.
58 patients will be included. In patients complaining of severe asthenia, with a non progressive neuro-oncological disease, and without criteria of depression revealed by HAD (Hospital Anxiety and Depression) scale, evaluation of fatigue will be done with the MFI 20 scale. Patients with a MFI 20 score ≥60/100 and corresponding to inclusion criteria will be invited to participate.
After randomisation, a baseline evaluation will be done, including MFI20, Norris VAS, EORTC QLQ-C30, Mattis scale, Trail Making Test, Grober and Buschke, Wisconsin Card Sorting Test , HAD scale and Marin scale.
Patients will receive, in a double blinded way, six pills a day either of dexamphetamine sulfate (15 mg*2) or of placebo, during 3 months, after an initial phase of progressive increasing levels of dose every 10 days, depending on tolerance.
The evaluation of fatigue, quality of life will be done every month during the 3 months of treatment. The cognitive evaluation will be done at 3 months.
The main criteria of evaluation is the variation during 3 months of the MFI 20 score in non progressive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamfetamine sulphate | Experimental | Drug: Dexamfetamine sulphateDexamfetamine Sulphate 5 mg Tablets |
| placebo | Placebo comparator | Drug: placeboAspect tablets identical to the active |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamfetamine sulphate10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90. | Drug | Dexamfetamine sulphate |
| placebo10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90. | Drug | placebo |
Primary outcome
Multidimensional Fatigue inventory - MFI 20 scale score
Time frame: 3 months
improvement of the MFI 20 score between the inclusion and the evaluation at 3 months in case of non progressive disease during this period of time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence LAIGLE-DONADEY, MD contact
Florence LAIGLE-DONADEY, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamfetamine sulphate in people with Glioma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence LAIGLE-DONADEY, MD (florence.laigle-donadey@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Fatigue inventory - MFI 20 scale score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.