Psychogenic Non Epileptic SeizureEDUQ-CPNENCT02311829
Evaluation of a Telephone Follow-up Procedure on the Quality of Life in Psychogenic Non-epileptic Seizures
A study testing Telephone follow-up device in people with Psychogenic Non Epileptic Seizure, run by Central Hospital, Nancy, France at 4 sites in France.
Trial summary
The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychogenic Non Epileptic Seizure
- What is being tested?
- Telephone follow-up device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2014to Jan 2018
- Phase
- Interventional
- 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
- Patient above 18 years old
- Affiliation to social security
- Evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years
- Diagnosis of PNES (associated or not with epilepsy) or laid confirmed following a video-EEG examination
- Standardized announcement of the disease made by a neurologist participant / PHRC training
- Good understanding of the French language
- Patient consented to participate in the study
Who cannot join
- Acute psychiatric pathology at the time of inclusion warranting urgent hospitalization (acute suicidal risk, Table delusional ...)
- Progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...)
- A patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...)
- Simultaneous participation to another therapeutic intervention study during the first 12 months
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Chu Dijon
Dijon, Bourgogne-Franche-Comté, 21 079
Martine LEMESLE, MD, 03 80 29 37 54 ext. +33, martine.lemesle@chu-dijon.fr
Benoît TROJAK, MD PHD, 03 80 29 37 54 ext. +33, benoit.trojak@chu-dijon.fr
- Recruiting
Chu Nancy
Nancy, Lorraine, 54 035
Louis MAILLARD, MD PHD, 03 83 85 16 86 ext. +33, l.maillard@chu-nancy.fr
Coraline HINGRAY, MD, 03 83 85 16 86 ext. +33, c.hingray@chu-nancy.fr
- Recruiting
Chu Reims
Reims, Champagne Ardennes, 51 092
Anne THIRIAUX, MD, 03 26 78 71 34 ext. +33, thiriauxanne@hotmail.com
Delphine RAUCHER CHENE, MD, 03 26 78 71 34 ext. +33, draucherchene@chu-reims.fr
- Recruiting
Chu Strasbourg
Strasbourg, Alsace, 67 098
Edouard HIRSCH, MD PHD, 03 88 11 67 68 ext. +33, Edouard.hirsch@chru-strasbourg.fr
Pierre VIDAILHET, MD PHD, 03 88 11 67 68 ext. +33, Pierre.VIDAILHET@chru-strasbourg.fr
About this study
Official title: Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques.
The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.
Read the detailed description
This study is a multicenter, non-drug therapy and randomized research trial, comparing a group of patients integrating the phone monitoring device (DST group) to a control group where patients are cared for in the usual way.
Subject recruiting modalities:
The study population represents patients diagnosis, PNES confirmed by following by the video-EEG, recorded in a center of epilepsy and in different CHU and informed of the diagnosis of PNES in a standardized manner.
Patients were recruited during their hospitalization video-EEG is conducted in part of the diagnostic workup of drug-resistant epilepsies, or demonstrations paroxysmal undetermined which may prove to be PNES.
Usual care:
After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannual with the neurologist.
In the study:
- For patients in both groups: Management usual care and, in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannually for 24 months after the appointment with the neurologist.
- For patients in the DST group only: Phone calls by psychologist at J 15, at 2 months, then every 2 months until M12. The device telephone follow (DST) consists of telephone calls (D15, M2, then every 2 months until M12) of the patient by an external independent psychologist designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended.
- Conditions
- Psychogenic Non Epileptic Seizure
- Being tested
- Telephone follow-up device
- Keywords
- Quality of life, PNES, Epilepsy,
- Medical subject headings
- Psychogenic Nonepileptic Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone follow-up deviceOther
For patients in the DST group only: Phone calls by clinical psychologist at J 15 at 2, then every 2 months until M12.
| Study group | Role | What they receive |
|---|---|---|
| Telephone follow-up device (DST) | Experimental | An external independent clinical psychologist is responsible for calling regular the patient included in DST-arm.
Telephone follow-up device(DST) consists of telephone calls at 15 day, 2 month and then every 2 months until 12 months. The clinical psychologist is designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended. Receives: Other: Telephone follow-up device |
| Group control ; usual care | No intervention | - Usual care: After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannually with the neurologist - For patients in both groups: in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannual for 24 months after the appointment with the neurologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of quality of life scores every 6 months (From 6 to 24 months)
The primary endpoint is the assessment of quality of life scores measured at 6, 12, 18 and 24 months after start of treatment (visit D0) by self-administered questionnaires of quality of life (SF-36 general questionnaire quality of life) and QOLIE 31 (specific questionnaire epilepsy).
Measured: 24 months
Secondary outcomes (5)
Frequency of non epileptic seizures per month
Seizures diaries follow
Measured: 24 months (average for 6 months)
Severity of seizures
Duration, injuries, loss of urine and feces, fall, loss of consciousness and subjective control feel of the listed crisis between 0 and 10 on EVA scale crisis control feel.
Measured: 24 months
Psychiatric symptomology scores
Questionnaires (DSM-IV, Beck 21, MADRS, HAMA, DES, SDQ-20, TAS 20, Brief COPE)
Measured: 24 months
Percentage of programmed psychological consultation and actually honored in medical and psychological center
This percentage is collected in medical and psychological center or from liberal psychiatrist \ psychologist (collected with phone call)
Measured: 24 months
Number of urgent consultations or unprogrammed and \ or unprogrammed
consultations ( SAMU, emergency, reanimation, unprogrammed neurological consultations).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for Psychogenic Non Epileptic SeizureStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Coraline HINGRAY, Pr Raymund SCHWAN, Dr Vincent LAPREVOTE, Dr Jean Pierre VIGNAL, Pr Hervé VESPIGNANI, Dr Anne THIRIAUX, Dr Delphine RAUCHER CHENE, Dr Martine LEMESLE, Dr Benoît TROJAK, Pr Edouard HIRSCH, Pr Pierre Vidailhet, Dr Dominique Mastelli
- Responsible party
- Sponsor
- Investigators
- Louis MAILLARD, PU-PH, HDR, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311829
- Sponsor's protocol ID
- 2012-A01580-43
- Acronym
- EDUQ-CPNE
- Status last verified
- Mar 2016
- First submitted
- 28 Oct 2014
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
LaFrance WC Jr, Alosco ML, Davis JD, Tremont G, Ryan CE, Keitner GI, Miller IW, Blum AS. Impact of family functioning on quality of life in patients with psychogenic nonepileptic seizures versus epilepsy. Epilepsia. 2011 Feb;52(2):292-300. doi: 10.1111/j.1528-1167.2010.02765.x. Epub 2011 Feb 7.
PubMed 21299547Duncan R, Razvi S, Mulhern S. Newly presenting psychogenic nonepileptic seizures: incidence, population characteristics, and early outcome from a prospective audit of a first seizure clinic. Epilepsy Behav. 2011 Feb;20(2):308-11. doi: 10.1016/j.yebeh.2010.10.022. Epub 2010 Dec 30.
PubMed 21195031Goldstein LH, Chalder T, Chigwedere C, Khondoker MR, Moriarty J, Toone BK, Mellers JD. Cognitive-behavioral therapy for psychogenic nonepileptic seizures: a pilot RCT. Neurology. 2010 Jun 15;74(24):1986-94. doi: 10.1212/WNL.0b013e3181e39658.
PubMed 20548043Hingray C, Maillard L, Hubsch C, Vignal JP, Bourgognon F, Laprevote V, Lerond J, Vespignani H, Schwan R. Psychogenic nonepileptic seizures: characterization of two distinct patient profiles on the basis of trauma history. Epilepsy Behav. 2011 Nov;22(3):532-6. doi: 10.1016/j.yebeh.2011.08.015. Epub 2011 Oct 1.
PubMed 21962755Howlett S, Grunewald RA, Khan A, Reuber M. Engagement in psychological treatment for functional neurological symptoms--Barriers and solutions. Psychotherapy (Chic). 2007 Sep;44(3):354-60. doi: 10.1037/0033-3204.44.3.354.
PubMed 22122261Hubsch C, Baumann C, Hingray C, Gospodaru N, Vignal JP, Vespignani H, Maillard L. Clinical classification of psychogenic non-epileptic seizures based on video-EEG analysis and automatic clustering. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):955-60. doi: 10.1136/jnnp.2010.235424. Epub 2011 May 10.
PubMed 21561887Jirsch JD, Ahmed SN, Maximova K, Gross DW. Recognition of psychogenic nonepileptic seizures diminishes acute care utilization. Epilepsy Behav. 2011 Oct;22(2):304-7. doi: 10.1016/j.yebeh.2011.06.031. Epub 2011 Aug 2.
PubMed 21813334Josien E. Crises non épileptiques. EMC neurologie. 2005 ;1-9.
LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.
PubMed 20739647Lesser RP. Psychogenic seizures. Neurology. 1996 Jun;46(6):1499-507. doi: 10.1212/wnl.46.6.1499. No abstract available.
PubMed 8649537Martin RC, Gilliam FG, Kilgore M, Faught E, Kuzniecky R. Improved health care resource utilization following video-EEG-confirmed diagnosis of nonepileptic psychogenic seizures. Seizure. 1998 Oct;7(5):385-90. doi: 10.1016/s1059-1311(05)80007-x.
PubMed 9808114Mayor R, Howlett S, Grunewald R, Reuber M. Long-term outcome of brief augmented psychodynamic interpersonal therapy for psychogenic nonepileptic seizures: seizure control and health care utilization. Epilepsia. 2010 Jul;51(7):1169-76. doi: 10.1111/j.1528-1167.2010.02656.x. Epub 2010 Jun 18.
PubMed 20561022Strutt AM, Hill SW, Scott BM, Uber-Zak L, Fogel TG. Motivation, psychopathology, locus of control, and quality of life in women with epileptic and nonepileptic seizures. Epilepsy Behav. 2011 Oct;22(2):279-84. doi: 10.1016/j.yebeh.2011.06.020. Epub 2011 Jul 23.
PubMed 21788158Worsley C, Whitehead K, Kandler R, Reuber M. Illness perceptions of health care workers in relation to epileptic and psychogenic nonepileptic seizures. Epilepsy Behav. 2011 Apr;20(4):668-73. doi: 10.1016/j.yebeh.2011.01.029. Epub 2011 Mar 25.
PubMed 21440511Abubakr A, Kablinger A, Caldito G. Psychogenic seizures: clinical features and psychological analysis. Epilepsy Behav. 2003 Jun;4(3):241-5. doi: 10.1016/s1525-5050(03)00082-9.
PubMed 12791325
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques.
- ClinicalTrials.gov ID
- NCT02311829
- Acronym / sponsor ID
- EDUQ-CPNE / 2012-A01580-43
- Conditions
- Psychogenic Non Epileptic Seizure
- Keywords
- Quality of life, PNES, Epilepsy,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Dr Coraline HINGRAY, Pr Raymund SCHWAN, Dr Vincent LAPREVOTE, Dr Jean Pierre VIGNAL, Pr Hervé VESPIGNANI, Dr Anne THIRIAUX, Dr Delphine RAUCHER CHENE, Dr Martine LEMESLE, Dr Benoît TROJAK, Pr Edouard HIRSCH, Pr Pierre Vidailhet, Dr Dominique Mastelli
- Study start
- Jan 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 8 Dec 2014 (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 goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.
Detailed description
This study is a multicenter, non-drug therapy and randomized research trial, comparing a group of patients integrating the phone monitoring device (DST group) to a control group where patients are cared for in the usual way.
Subject recruiting modalities:
The study population represents patients diagnosis, PNES confirmed by following by the video-EEG, recorded in a center of epilepsy and in different CHU and informed of the diagnosis of PNES in a standardized manner.
Patients were recruited during their hospitalization video-EEG is conducted in part of the diagnostic workup of drug-resistant epilepsies, or demonstrations paroxysmal undetermined which may prove to be PNES.
Usual care:
After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannual with the neurologist.
In the study:
- For patients in both groups: Management usual care and, in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannually for 24 months after the appointment with the neurologist.
- For patients in the DST group only: Phone calls by psychologist at J 15, at 2 months, then every 2 months until M12. The device telephone follow (DST) consists of telephone calls (D15, M2, then every 2 months until M12) of the patient by an external independent psychologist designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone follow-up device (DST) | Experimental | Other: Telephone follow-up deviceAn external independent clinical psychologist is responsible for calling regular the patient included in DST-arm. Telephone follow-up device(DST) consists of telephone calls at 15 day, 2 month and then every 2 months until 12 months. The clinical psychologist is designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended. |
| Group control ; usual care | No intervention | –- Usual care: After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannually with the neurologist - For patients in both groups: in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannual for 24 months after the appointment with the neurologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient above 18 years old
- Affiliation to social security
- Evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years
- Diagnosis of PNES (associated or not with epilepsy) or laid confirmed following a video-EEG examination
- Standardized announcement of the disease made by a neurologist participant / PHRC training
Key exclusion criteria (4 listed)
- Acute psychiatric pathology at the time of inclusion warranting urgent hospitalization (acute suicidal risk, Table delusional ...)
- Progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...)
- A patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...)
- Simultaneous participation to another therapeutic intervention study during the first 12 months
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 |
|---|---|---|
| Telephone follow-up deviceFor patients in the DST group only: Phone calls by clinical psychologist at J 15 at 2, then every 2 months until M12. | Other | Telephone follow-up device (DST) |
Primary outcome
Evolution of quality of life scores every 6 months (From 6 to 24 months)
Time frame: 24 months
The primary endpoint is the assessment of quality of life scores measured at 6, 12, 18 and 24 months after start of treatment (visit D0) by self-administered questionnaires of quality of life (SF-36 general questionnaire quality of life) and QOLIE 31 (specific questionnaire epilepsy).
5 secondary outcomes
Frequency of non epileptic seizures per month
Time frame: 24 months (average for 6 months)
Severity of seizures
Time frame: 24 months
Psychiatric symptomology scores
Time frame: 24 months
Percentage of programmed psychological consultation and actually honored in medical and psychological center
Time frame: 24 months
Number of urgent consultations or unprogrammed and \ or unprogrammed
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Background: PubMed 21299547LaFrance WC Jr, Alosco ML, Davis JD, Tremont G, Ryan CE, Keitner GI, Miller IW, Blum AS. Impact of family functioning on quality of life in patients with psychogenic nonepileptic seizures versus epilepsy. Epilepsia. 2011 Feb;52(2):292-300. doi: 10.1111/j.1528-1167.2010.02765.x. Epub 2011 Feb 7.
- Background: PubMed 21195031Duncan R, Razvi S, Mulhern S. Newly presenting psychogenic nonepileptic seizures: incidence, population characteristics, and early outcome from a prospective audit of a first seizure clinic. Epilepsy Behav. 2011 Feb;20(2):308-11. doi: 10.1016/j.yebeh.2010.10.022. Epub 2010 Dec 30.
- Background: PubMed 20548043Goldstein LH, Chalder T, Chigwedere C, Khondoker MR, Moriarty J, Toone BK, Mellers JD. Cognitive-behavioral therapy for psychogenic nonepileptic seizures: a pilot RCT. Neurology. 2010 Jun 15;74(24):1986-94. doi: 10.1212/WNL.0b013e3181e39658.
- Background: PubMed 21962755Hingray C, Maillard L, Hubsch C, Vignal JP, Bourgognon F, Laprevote V, Lerond J, Vespignani H, Schwan R. Psychogenic nonepileptic seizures: characterization of two distinct patient profiles on the basis of trauma history. Epilepsy Behav. 2011 Nov;22(3):532-6. doi: 10.1016/j.yebeh.2011.08.015. Epub 2011 Oct 1.
- Background: PubMed 22122261Howlett S, Grunewald RA, Khan A, Reuber M. Engagement in psychological treatment for functional neurological symptoms--Barriers and solutions. Psychotherapy (Chic). 2007 Sep;44(3):354-60. doi: 10.1037/0033-3204.44.3.354.
- Background: PubMed 21561887Hubsch C, Baumann C, Hingray C, Gospodaru N, Vignal JP, Vespignani H, Maillard L. Clinical classification of psychogenic non-epileptic seizures based on video-EEG analysis and automatic clustering. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):955-60. doi: 10.1136/jnnp.2010.235424. Epub 2011 May 10.
- Background: PubMed 21813334Jirsch JD, Ahmed SN, Maximova K, Gross DW. Recognition of psychogenic nonepileptic seizures diminishes acute care utilization. Epilepsy Behav. 2011 Oct;22(2):304-7. doi: 10.1016/j.yebeh.2011.06.031. Epub 2011 Aug 2.
- BackgroundJosien E. Crises non épileptiques. EMC neurologie. 2005 ;1-9.
- Background: PubMed 20739647LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.
- Background: PubMed 8649537Lesser RP. Psychogenic seizures. Neurology. 1996 Jun;46(6):1499-507. doi: 10.1212/wnl.46.6.1499. No abstract available.
- Background: PubMed 9808114Martin RC, Gilliam FG, Kilgore M, Faught E, Kuzniecky R. Improved health care resource utilization following video-EEG-confirmed diagnosis of nonepileptic psychogenic seizures. Seizure. 1998 Oct;7(5):385-90. doi: 10.1016/s1059-1311(05)80007-x.
- Background: PubMed 20561022Mayor R, Howlett S, Grunewald R, Reuber M. Long-term outcome of brief augmented psychodynamic interpersonal therapy for psychogenic nonepileptic seizures: seizure control and health care utilization. Epilepsia. 2010 Jul;51(7):1169-76. doi: 10.1111/j.1528-1167.2010.02656.x. Epub 2010 Jun 18.
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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.
Louis MAILLARD, PU-PH, HDR principal investigator
Central Hospital, Nancy, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone follow-up device in people with Psychogenic Non Epileptic Seizure, run by Central Hospital, Nancy, France at 4 sites 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 7 inclusion and 4 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 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Louis MAILLARD, PU-PH, HDR (03 83 85 16 86 ext. +33, l.maillard@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of quality of life scores every 6 months (From 6 to 24 months) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311829, which also lists 64 linked publications.
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 8 Mar 2016.