Medication Overuse HeadacheCOMOESTASNCT02435056
Medication Overuse Headache (MOH) and an Innovative Approach
A study testing IEPR Approach in people with Medication Overuse Headache, run by IRCCS National Neurological Institute "C. Mondino" Foundation.
Trial summary
Appropriate delivery of quality healthcare requires constant monitoring of the patient during follow up, particularly in the presence of chronic diseases. This approach can be further improved if leading edge tools supporting diagnosis, as well as prediction, identification and monitoring of adverse events are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Overuse Headache
- What is being tested?
- IEPR Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jun 2010
- 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
- Patients with MOH
Who cannot join
- a current diagnosis of co-existent, significant and complicating medical or psychiatric illnesses
- significant overuse of "pure" opioids (patients overusing combination drugs containing opioids are allowed), benzodiazepines, and barbiturates,
- overuse of alcohol and other drugs of addiction,
- current treatment with migraine prophylactic drugs
- inefficacy of previous adequate detoxification programmes
- inability to provide reliable information about medical history
- pregnancy or breast feeding
- inability to learn how to use paper or electronic diaries
About this study
Official title: Continuous Monitoring of Medication Overuse Headache in Europe and Latin America: Development and STAndardization of an Alert and Decision Support System
Appropriate delivery of quality healthcare requires constant monitoring of the patient during follow up, particularly in the presence of chronic diseases. This approach can be further improved if leading edge tools supporting diagnosis, as well as prediction, identification and monitoring of adverse events are available. COMOESTAS aims to develop an innovative Information Communications Technology (ICT) system that allows patients with a chronic condition to receive continuous and personalized treatment. The whole system is based on an advanced, "all in one" Alerting and Decision Support System that follows patients from the diagnosis and supports the physician in managing the therapy, controlling relevant events impacting on patient safety and activating specific procedures if selected thresholds are exceeded. In the frame of chronic neurological disorders, Medication Overuse Headache (MOH) is a common condition and a major cause of disability. MOH is curable, but its outcome is hampered by a high risk of relapse. It is, therefore, a perfect example of a disorder that can benefit from an ICT-assisted approach developing innovative systems and services for monitoring chronic conditions. COMOESTAS goals will be achieved by improving and integrating the traditional paper headache diaries and calendars into an innovative ICT tool taking into account the complex issues that accompany this peculiar form of headache, which will make the patient a key node in the entire process.
Read the detailed description
It will be a multicentre parallel group study. The two arms of the clinical protocol will be 1) classic approach to MOH and 2) Interactive Electronic Patient Record (IEPR)-based approach to MOH.
Each arm will last 12 months.
MOH will be diagnosed according to the 2006 MOH-R criteria of the International Headache Society as reported below:
- Headache present on > 15 days/month.
- Regular overuse for > 3 months of one or more acute symptomatic drugs:
- Ergotamine, triptans, opioids or combination analgesic medications on > 10 days/month on a regular basis for > 3 months.
- Simple analgesics or any combination of ergotamine, triptans, analgesics or opioids on > 15 days/month on a regular basis for >3 months without overuse (> 10 days) of any single class alone.
- Headache has developed or markedly worsened during medication overuse.
The IEPR approach will be preliminarily tested and validated in small groups of patients during months 6-12 (pilot validation).
Each patient will be evaluated over a period of 7 months.
Classic approach Visit 0: patient is examined and, if suspected to suffer from MOH, is asked to fill in a diary for a month in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.). Patient has to report that MOH-R criteria were fulfilled for the previous 2 months.
Visit 1: Patient returns to the Centre, diary data are analyzed and recorded, and, if criteria for MOH-R diagnosis are fulfilled and exclusion criteria are ruled out , patient is enrolled in COMOESTAS protocol.
Detoxification: following visit 1, patient undergoes detoxification according to the protocol in Appendix 1. In the subsequent 2 months the patient is instructed to record headache characteristics and consumption of symptomatic drugs on a paper diary.
Visit 2 (2 months after detoxification): patient is visited again; diary is checked; if therapy is successful (patient no longer overuses acute medications for headache) the patient is scheduled for a follow-up visit after 4 months. The patient is asked to keep up recording headache characteristics and consumption of symptomatic drugs on a paper diary for the next 4 months and informed about a telephone contact after 2 months.
Visit 3 (6 months after detoxification): patient is visited again, diary data are collected. Study ends.
IEPR approach Visit 0: patient is examined and, if the minimum data set of the IEPR for MOH is satisfied, the patients is asked to record the headache characteristics as well as acute drugs consumption on a paper diary for a month in order to assess baseline parameters of MOH (days with headache, acute drugs consumed, etc.).
Patient has to report that MOH-R criteria were fulfilled for the previous 2 months.
Visit 1: Patient returns to the Centre, diary data are analyzed and recorded, and, if criteria for MOH diagnosis are confirmed and criteria of exclusion are ruled out, patient is enrolled in COMOESTAS protocol .
Detoxification: following Visit 1, patient undergoes detoxification according to the same protocol adopted for the classic approach. During the detoxification phase, the patient is instructed to use the electronic diary and is then asked to fill the electronic diary on a regular basis (preferably daily or at least weekly) for the next 6 months.
Visit 2 (2 months after detoxification): patient is visited again; if therapy is successful (patient no longer overuses acute medications for headache), MOH diagnosis the patient is scheduled for a follow-up visit after 4 months and informed about a telephone contact after 2 months. The patient is asked to keep up filling the electronic diary for the next 4 months.
Visit 3: the patient is visited again. Study ends.
- Conditions
- Medication Overuse Headache
- Being tested
- IEPR Approach
- Keywords
- medication overuse headache, health care system
- Medical subject headings
- Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IEPR ApproachOther
Adoption of Interactive Electronic Patient Record (IEPR) that consists of the following clinically-relevant main components:
- Minimum Data Set for supporting the diagnosis
- Electronic Diary with associated alerting system for monitoring the patient during the follow-up period
- Second opinion system for improving the management
| Study group | Role | What they receive |
|---|---|---|
| Classic Approach | No intervention | Patient fills in a paper diary in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.) |
| IEPR Approach | Experimental | Patient has to use the electronic diary to record days with headache, acute drugs consumed, etc. Receives: Other: IEPR Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Rate Follow up
Relapse Rate 6 months after withdrawal of patients with medication overuse. Relapse will be defined as use of ergotamine, triptans, opioids or combination analgesic medications on > 10 days/month or use of simple analgesics or any combination of ergotamine, triptans, analgesics or opioids on > 15 days/month during the previous month, with the exclusion of month +1.
Measured: 6 month
Secondary outcomes (7)
Days with headache
Number of days with headache before and after detoxification in the two arms (month -1 vs. month +6)
Measured: 6 month
Days per month with migraine
Number of days per month with migraine before and after detoxification in the two arms (month -1 vs. month +6)
Measured: 6 month
MOH patients/total number of headache
Number of MOH patients/total number of headache patients during the recruitment period (6-12 months ) of the two arms
Measured: 12 month
MOH patients/total number of headache
Number of MOH patients/total number of headache patients during the recruitment period (18-24 months ) of the two arms
Measured: 24 month
Drop-outs
Number of drop-outs in the two arms
Measured: 24 month
Midas scores
Changes in Midas scores in the two arms
Measured: 24 month
HURT scores
Changes in HURT scores in the two arms
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Medication Overuse HeadacheStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Nappi, MD, Study director, IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia, ITALYRigmor Jensen, MD, PhD, Principal investigator, Glostrup Hospital, Copenaghen, DenmarkZaza Katsarava, MD, PHD, MSc, Principal investigator, Universitaetsklinikum, Essen, GermanyJorge Leston, MD, Principal investigator, Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, ArgentinaRicardo Fadic, MD, Principal investigator, Pontificia Universidad Catolica de ChileMiguel JA Lainez, MD, PhD, Principal investigator, Fundacion de la Comunidad Valenciana para la Investigacion Biomedica, la Docencia Y la Cooperacion Internacional y para el Desarrollo del Hospital Clinico Universitario De Valencia, SpainMarco Pagani, Manager, Principal investigator, Consorzio di Bioingegneria Medica, Pavia, ItalyNestor Gorini, Principal investigator, Ministerio de la Salud de la Provincia de Buenos Aires, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435056
- Sponsor's protocol ID
- 215366
- Acronym
- COMOESTAS
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rossi P, Di Lorenzo C, Faroni J, Cesarino F, Nappi G. Advice alone vs. structured detoxification programmes for medication overuse headache: a prospective, randomized, open-label trial in transformed migraine patients with low medical needs. Cephalalgia. 2006 Sep;26(9):1097-105. doi: 10.1111/j.1468-2982.2006.01175.x.
PubMed 16919060Diener HC, Limmroth V. Medication-overuse headache: a worldwide problem. Lancet Neurol. 2004 Aug;3(8):475-83. doi: 10.1016/S1474-4422(04)00824-5.
PubMed 15261608Zeeberg P, Olesen J, Jensen R. Discontinuation of medication overuse in headache patients: recovery of therapeutic responsiveness. Cephalalgia. 2006 Oct;26(10):1192-8. doi: 10.1111/j.1468-2982.2006.01190.x.
PubMed 16961785Zeeberg P, Olesen J, Jensen R. Probable medication-overuse headache: the effect of a 2-month drug-free period. Neurology. 2006 Jun 27;66(12):1894-8. doi: 10.1212/01.wnl.0000217914.30994.bd. Epub 2006 May 17.
PubMed 16707727Haag G, Baar H, Grotemeyer KH, Pfaffenrath V, Ribbat MJ, Diener HC. [Prophylaxis and treatment of drug-induced persistent headache. Therapy recommendation of the German Society for Migraine and Headache]. Schmerz. 1999 Feb 18;13(1):52-7. doi: 10.1007/s004829900016. No abstract available. German.
PubMed 12799950Headache Classification Committee; Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Gobel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F, Schoenen J, Silberstein SD, Steiner TJ. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742-6. doi: 10.1111/j.1468-2982.2006.01172.x.
PubMed 16686915Jellestad PL, Carlsen LN, Westergaard ML, Munksgaard SB, Bendtsen L, Lainez M, Fadic R, Katsarava Z, Goicochea MT, Spadafora S, Jensen RH, Nappi G, Tassorelli C; COMOESTAS Consortium. Economic benefits of treating medication-overuse headache - results from the multicenter COMOESTAS project. Cephalalgia. 2019 Feb;39(2):274-285. doi: 10.1177/0333102418786265. Epub 2018 Jul 8.
PubMed 29984608Tassorelli C, Jensen R, Allena M, De Icco R, Katsarava Z, Miguel Lainez J, Leston JA, Fadic R, Spadafora S, Pagani M, Nappi G; COMOESTAS Consortium. The added value of an electronic monitoring and alerting system in the management of medication-overuse headache: A controlled multicentre study. Cephalalgia. 2017 Oct;37(12):1115-1125. doi: 10.1177/0333102416660549. Epub 2016 Jul 20.
PubMed 27440251
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Medication Overuse Headache in Europe and Latin America: Development and STAndardization of an Alert and Decision Support System
- ClinicalTrials.gov ID
- NCT02435056
- Acronym / sponsor ID
- COMOESTAS / 215366
- Conditions
- Medication Overuse Headache
- Keywords
- medication overuse headache, health care system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 May 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.
Appropriate delivery of quality healthcare requires constant monitoring of the patient during follow up, particularly in the presence of chronic diseases. This approach can be further improved if leading edge tools supporting diagnosis, as well as prediction, identification and monitoring of adverse events are available. COMOESTAS aims to develop an innovative Information Communications Technology (ICT) system that allows patients with a chronic condition to receive continuous and personalized treatment. The whole system is based on an advanced, "all in one" Alerting and Decision Support System that follows patients from the diagnosis and supports the physician in managing the therapy, controlling relevant events impacting on patient safety and activating specific procedures if selected thresholds are exceeded. In the frame of chronic neurological disorders, Medication Overuse Headache (MOH) is a common condition and a major cause of disability. MOH is curable, but its outcome is hampered by a high risk of relapse. It is, therefore, a perfect example of a disorder that can benefit from an ICT-assisted approach developing innovative systems and services for monitoring chronic conditions. COMOESTAS goals will be achieved by improving and integrating the traditional paper headache diaries and calendars into an innovative ICT tool taking into account the complex issues that accompany this peculiar form of headache, which will make the patient a key node in the entire process.
Detailed description
It will be a multicentre parallel group study. The two arms of the clinical protocol will be 1) classic approach to MOH and 2) Interactive Electronic Patient Record (IEPR)-based approach to MOH.
Each arm will last 12 months.
MOH will be diagnosed according to the 2006 MOH-R criteria of the International Headache Society as reported below:
- Headache present on > 15 days/month.
- Regular overuse for > 3 months of one or more acute symptomatic drugs:
- Ergotamine, triptans, opioids or combination analgesic medications on > 10 days/month on a regular basis for > 3 months.
- Simple analgesics or any combination of ergotamine, triptans, analgesics or opioids on > 15 days/month on a regular basis for >3 months without overuse (> 10 days) of any single class alone.
- Headache has developed or markedly worsened during medication overuse.
The IEPR approach will be preliminarily tested and validated in small groups of patients during months 6-12 (pilot validation).
Each patient will be evaluated over a period of 7 months.
Classic approach Visit 0: patient is examined and, if suspected to suffer from MOH, is asked to fill in a diary for a month in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.). Patient has to report that MOH-R criteria were fulfilled for the previous 2 months.
Visit 1: Patient returns to the Centre, diary data are analyzed and recorded, and, if criteria for MOH-R diagnosis are fulfilled and exclusion criteria are ruled out , patient is enrolled in COMOESTAS protocol.
Detoxification: following visit 1, patient undergoes detoxification according to the protocol in Appendix 1. In the subsequent 2 months the patient is instructed to record headache characteristics and consumption of symptomatic drugs on a paper diary.
Visit 2 (2 months after detoxification): patient is visited again; diary is checked; if therapy is successful (patient no longer overuses acute medications for headache) the patient is scheduled for a follow-up visit after 4 months. The patient is asked to keep up recording headache characteristics and consumption of symptomatic drugs on a paper diary for the next 4 months and informed about a telephone contact after 2 months.
Visit 3 (6 months after detoxification): patient is visited again, diary data are collected. Study ends.
IEPR approach Visit 0: patient is examined and, if the minimum data set of the IEPR for MOH is satisfied, the patients is asked to record the headache characteristics as well as acute drugs consumption on a paper diary for a month in order to assess baseline parameters of MOH (days with headache, acute drugs consumed, etc.).
Patient has to report that MOH-R criteria were fulfilled for the previous 2 months.
Visit 1: Patient returns to the Centre, diary data are analyzed and recorded, and, if criteria for MOH diagnosis are confirmed and criteria of exclusion are ruled out, patient is enrolled in COMOESTAS protocol .
Detoxification: following Visit 1, patient undergoes detoxification according to the same protocol adopted for the classic approach. During the detoxification phase, the patient is instructed to use the electronic diary and is then asked to fill the electronic diary on a regular basis (preferably daily or at least weekly) for the next 6 months.
Visit 2 (2 months after detoxification): patient is visited again; if therapy is successful (patient no longer overuses acute medications for headache), MOH diagnosis the patient is scheduled for a follow-up visit after 4 months and informed about a telephone contact after 2 months. The patient is asked to keep up filling the electronic diary for the next 4 months.
Visit 3: the patient is visited again. Study ends.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic Approach | No intervention | –Patient fills in a paper diary in order to quantify parameters of MOH (days with headache, acute drugs consumed, etc.) |
| IEPR Approach | Experimental | Other: IEPR ApproachPatient has to use the electronic diary to record days with headache, acute drugs consumed, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with MOH
Key exclusion criteria (8 listed)
- a current diagnosis of co-existent, significant and complicating medical or psychiatric illnesses
- significant overuse of "pure" opioids (patients overusing combination drugs containing opioids are allowed), benzodiazepines, and barbiturates,
- overuse of alcohol and other drugs of addiction,
- current treatment with migraine prophylactic drugs
- inefficacy of previous adequate detoxification programmes
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 |
|---|---|---|
| IEPR ApproachAdoption of Interactive Electronic Patient Record (IEPR) that consists of the following clinically-relevant main components: * Minimum Data Set for supporting the diagnosis * Electronic Diary with associated alerting system for monitoring the patient during the follow-up period * Second opinion system for improving the management | Other | IEPR Approach |
Primary outcome
Relapse Rate Follow up
Time frame: 6 month
Relapse Rate 6 months after withdrawal of patients with medication overuse. Relapse will be defined as use of ergotamine, triptans, opioids or combination analgesic medications on > 10 days/month or use of simple analgesics or any combination of ergotamine, triptans, analgesics or opioids on > 15 days/month during the previous month, with the exclusion of month +1.
7 secondary outcomes
Days with headache
Time frame: 6 month
Days per month with migraine
Time frame: 6 month
MOH patients/total number of headache
Time frame: 12 month
MOH patients/total number of headache
Time frame: 24 month
Drop-outs
Time frame: 24 month
Midas scores
Time frame: 24 month
HURT scores
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Background: PubMed 16919060Rossi P, Di Lorenzo C, Faroni J, Cesarino F, Nappi G. Advice alone vs. structured detoxification programmes for medication overuse headache: a prospective, randomized, open-label trial in transformed migraine patients with low medical needs. Cephalalgia. 2006 Sep;26(9):1097-105. doi: 10.1111/j.1468-2982.2006.01175.x.
- Background: PubMed 15261608Diener HC, Limmroth V. Medication-overuse headache: a worldwide problem. Lancet Neurol. 2004 Aug;3(8):475-83. doi: 10.1016/S1474-4422(04)00824-5.
- Background: PubMed 16961785Zeeberg P, Olesen J, Jensen R. Discontinuation of medication overuse in headache patients: recovery of therapeutic responsiveness. Cephalalgia. 2006 Oct;26(10):1192-8. doi: 10.1111/j.1468-2982.2006.01190.x.
- Background: PubMed 16707727Zeeberg P, Olesen J, Jensen R. Probable medication-overuse headache: the effect of a 2-month drug-free period. Neurology. 2006 Jun 27;66(12):1894-8. doi: 10.1212/01.wnl.0000217914.30994.bd. Epub 2006 May 17.
- Background: PubMed 12799950Haag G, Baar H, Grotemeyer KH, Pfaffenrath V, Ribbat MJ, Diener HC. [Prophylaxis and treatment of drug-induced persistent headache. Therapy recommendation of the German Society for Migraine and Headache]. Schmerz. 1999 Feb 18;13(1):52-7. doi: 10.1007/s004829900016. No abstract available. German.
- Background: PubMed 16686915Headache Classification Committee; Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Gobel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F, Schoenen J, Silberstein SD, Steiner TJ. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742-6. doi: 10.1111/j.1468-2982.2006.01172.x.
- Derived from this study: PubMed 29984608Jellestad PL, Carlsen LN, Westergaard ML, Munksgaard SB, Bendtsen L, Lainez M, Fadic R, Katsarava Z, Goicochea MT, Spadafora S, Jensen RH, Nappi G, Tassorelli C; COMOESTAS Consortium. Economic benefits of treating medication-overuse headache - results from the multicenter COMOESTAS project. Cephalalgia. 2019 Feb;39(2):274-285. doi: 10.1177/0333102418786265. Epub 2018 Jul 8.
- Derived from this study: PubMed 27440251Tassorelli C, Jensen R, Allena M, De Icco R, Katsarava Z, Miguel Lainez J, Leston JA, Fadic R, Spadafora S, Pagani M, Nappi G; COMOESTAS Consortium. The added value of an electronic monitoring and alerting system in the management of medication-overuse headache: A controlled multicentre study. Cephalalgia. 2017 Oct;37(12):1115-1125. doi: 10.1177/0333102416660549. Epub 2016 Jul 20.
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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.
Giuseppe Nappi, MD study director
IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia, ITALY
Rigmor Jensen, MD, PhD principal investigator
Glostrup Hospital, Copenaghen, Denmark
Zaza Katsarava, MD, PHD, MSc principal investigator
Universitaetsklinikum, Essen, Germany
Questions about this trial
What is this clinical trial studying?
A study testing IEPR Approach in people with Medication Overuse Headache, run by IRCCS National Neurological Institute "C. Mondino" Foundation.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Rate Follow up (time frame: 6 month). 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 NCT02435056, which also lists 8 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 6 May 2015.