NCT02363075

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 15, 2016

Status Verified

August 1, 2016

Enrollment Period

4.3 years

First QC Date

February 9, 2015

Last Update Submit

September 14, 2016

Conditions

Glioma

Keywords

dexamfetamine sulphatesevere astheniagliomaMFI-20double-blindstabilisation phase

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Study Arms (2)

Dexamfetamine sulphate

EXPERIMENTAL

Dexamfetamine Sulphate 5 mg Tablets

Drug: Dexamfetamine sulphate

placebo

PLACEBO COMPARATOR

Aspect tablets identical to the active

Drug: placebo

Interventions

Dexamfetamine sulphateDRUG

10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.

Dexamfetamine sulphate
placeboDRUG

10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitie Salpetriere

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

GliomaAsthenia

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Florence LAIGLE-DONADEY, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence LAIGLE-DONADEY, MD

CONTACT

florence.laigle-donadey@psl.aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

April 1, 2013

Primary Completion

July 1, 2017

Study Completion

January 1, 2018

Last Updated

September 15, 2016

Record last verified: 2016-08

Locations

FR(1)