Multiple Sclerosis, Relapsing-RemittingPhase 2NCT02493049
Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis (RRMS)
A Phase 2 study testing Domperidone in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Calgary at 1 site in Canada.
Trial summary
The first major objective of this pilot trial is to demonstrate that it is possible to study myelin repair in relapsing-remitting multiple sclerosis (RRMS) patients with enhancing lesions on MRI by using advanced imaging techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Domperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Feb 2019
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be between age 18 and 60 years.
- Sexually active men and women of child-bearing potential, defined as those who are not postmenopausal (24 consecutive months) or permanently sterilised, must agree to use adequate contraception. Adequate contraception is defined as methods of birth control which result in a low failure rate [i.e. less than 1% per year] when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), barrier contraceptives, sexual abstinence or vasectomised partner. Adequate contraception is required during domperidone treatment and for one month after stopping treatment.
- Participants must have MS defined according to the McDonald criteria (Polman et al. 2011).
- Participants must have RRMS according to Lublin et al. (2014).
- Participants must have been treated with a stable approved dose of glatiramer acetate, interferon-beta, fingolimod, dimethyl fumarate, or teriflunomide for at least 6 months.
- Participants must be scheduled to have a clinically indicated brain MRI to monitor DMT effectiveness.
Show all 10Show fewer
- Participants must have at least one gadolinium enhancing lesion on their DMT monitoring MRI (screening MRI).
- Participants must report at least 80% adherence to their current DMT and have had no treatment discontinuation for one week or longer within the prior 6 months.
- Participants must be patients of the Calgary MS Clinic.
- Participants must provide written informed consent
Who cannot join
- Participants who are pregnant or breastfeeding
- Participants in whom it is expected that their current DMT will be discontinued within 16 weeks. Indicators of likely discontinuation will include poor DMT tolerance, a wish by the participant to discontinue the DMT, or a history of poor clinical response to the current DMT (such as a relapse within the previous year while on the current DMT)
- Participants who have a long QT interval, defined as corrected QT interval of more than 470 msec in men and more than 450 msec in women, on screening ECG.
- Participants with known long-QT syndrome or known cardiac arrhythmia.
- Participants who currently or previously have been treated with natalizumab.
- Participants who are currently treated with domperidone or have taken it within the previous 3 months.
Show all 15Show fewer
- Participants who are taking drugs which prolong QT intervals or who are treated with drugs that inhibit cytochrome P450 3A4.
- Participants who are concurrently treated with drugs that may increase serum prolactin levels.
- Participants who have a prolactinoma
- Participants who use systemic corticosteroids within the 8 weeks prior to the screening MRI or who use concurrent immunosuppressive medications including systemic corticosteroids.
- Participants who have a history of breast cancer or breast carcinoma in situ or who have clinically significant depression, renal, hepatic, cardiovascular, respiratory, metabolic, ophthalmologic, cerebrovascular, or other serious physical disease.
- Participants in whom gastrointestinal stimulation might be dangerous, i.e. gastrointestinal hemorrhage or mechanical obstruction or perforation
- Participants who have a known allergy or other intolerability to domperidone.
- Participants with serum potassium, sodium, magnesium or calcium levels outside the normal range, serum creatinine > 6 mg/100 ml or > 0.6 mmol/l), or who have any other condition or situation that in the opinion of the investigator would either put the patient at risk of worsening health if enrolled in the trial or would prevent completion of the trial.
- Participants who are concurrently participating in any therapeutic clinical trial.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Calgary MS Clinic at Foothills Medical Centre
Calgary, Alberta, T2N 2T9
About this study
Official title: Randomized, Controlled Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis
The first major objective of this pilot trial is to demonstrate that it is possible to study myelin repair in relapsing-remitting multiple sclerosis (RRMS) patients with enhancing lesions on MRI by using advanced imaging techniques. To demonstrate that this is possible the investigators will recruit 24 RRMS patients who are being treated with standard disease modifying therapy (DMT) and have new lesions identified on clinically indicated brain MRI scans and measure myelin repair at 16 and 32 weeks using MRI measures of myelin repair. The second major objective is to determine how much repair occurs in participants treated with domperidone compared with those who are not treated. This will allow us to design larger trials to confirm that domperidone improves repair. The study will also confirm the safety and tolerability of domperidone in RRMS, determine circulating prolactin levels during dosing with domperidone 10mg three times daily in people with RRMS, and explore the impact of other clinical factors (such as age) on lesion repair.
In addition, blood will be collected to test for metabolomics and the investigators will bank blood for future study of biomarkers that can help the investigators better understand MS. Metabolomics is an experimental test where changes in the pattern of the chemicals in blood cells are compared at different time points (during and after inflammation). There will be random changes but changes that are common in most study participants may help identify chemicals that signal stages in injury or repair. The investigators will also compare the pattern of change in those with the best repair to those with the worst repair. This may help identify a chemical that is associated with better or worse repair and help develop new treatment strategies. There are currently no blood tests that help in the diagnosis of MS, help determine which drug a person will respond to, or help determine a person's expected MS outcome. Any such tests would be considered biomarkers.
Read the detailed description
Primary Objectives:
- To demonstrate that the investigators can recruit DMT treated RRMS patients who have breakthrough enhancing lesions identified on clinically indicated monitoring brain MRI scans and measure lesion repair over 32 weeks.
- To obtain estimates of the magnitude and variability of lesion repair in DMT treated RRMS patients who are taking add-on domperidone, or no add-on treatment. The investigators will evaluate three MRI measures [texture analysis, diffusion tensor imaging (DTI), and magnetization transfer imaging (MTI)] for their ability to measure repair within acute enhancing lesions in RRMS. They will also evaluate repair at 16 and 32 weeks. These outcomes will aid in the development of future trials.
No therapies have yet been shown to improve lesion repair, and there is no accepted trial model to evaluate lesion repair in humans. Therefore, the investigators anticipate that the data from this trial will inform the design of future phase 2 trials of therapies to promote lesion repair in MS.
Secondary Objectives:
- To determine the safety and tolerability of domperidone in RRMS
- To determine serum prolactin levels during dosing with domperidone 10mg tid in this population
- To explore metabolomic profiling during lesion repair.
- To explore the impact of the following variables on lesion repair: prolactin level at 6 weeks, concurrent use of each type of DMT, Vitamin D and B12 levels at baseline, patient clinical characteristics (MS duration, EDSS), imaging characteristics (T2 lesion volume, enhancing lesion volume), patient demographics and behaviours (age, sex, smoking status).
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Domperidone
- Keywords
- Multiple Sclerosis, Domperidone, Relapsing-Remitting MS, Demyelinating disease, Remyelination
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
Also called domperidone maleate
Addition of Domperidone to current Disease Modifying Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Domperidone | Experimental | Add on oral Domperidone 10 mg, three times daily. Target dose:30mg daily. Duration: 16 weeks Receives: Drug: Domperidone |
| No add on treatment | No intervention | No add on treatment. Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of repair within enhancing T1 MRI lesions
Texture analysis, Diffusion Tensor Imaging (DTI) and Magnetization Transfer Imaging (MTI) will be used. This is a pilot study so the investigators are measuring repair at 2 time points and with 3 imaging methods to aid in the design of future studies.
Measured: up to 32 weeks
Secondary outcomes (2)
Number and type of adverse events over the 16 week treatment period.
Adverse events will be collected at all visits and by telephone if an encounter occurs. Clinical outcomes are not sufficiently sensitive or specific to stand as measures of repair in phase 2 clinical trials that aim to screen therapies for their potential to provide neuroprotection or enhance repair. Therefore the investigators will only use clinical measures at the baseline visit to describe participants with regards to level of clinical impairment. The investigators will use the standard measure of clinical impairment, the EDSS. The baseline neurological examination and EDSS will also be used to confirm the occurrence of a relapse. A relapse that occurs during the treatment period in a participant on domperidone will be considered an adverse event. Enhancing lesions on MRI after baseline will also be considered adverse events.
Measured: at 6 and 16 weeks
Serum Prolactin Levels at both 6 and 16 weeks
To determine how much domperidone 10mg three times daily increases serum prolactin levels in this MS population over time. The investigators will also explore the relationship between prolactin level and repair.
Measured: at 6 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Responsible party
- Principal investigator, Dr. Luanne Metz, University of Calgary
- Investigators
- Luanne M Metz, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493049
- Sponsor's protocol ID
- DOM-RRMS-01
- Status last verified
- Oct 2019
- First submitted
- 2 Jul 2015
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: consent to share IPD was not obtained so we cannot share
Publications
Alonso-Ortiz E, Levesque IR, Pike GB. MRI-based myelin water imaging: A technical review. Magn Reson Med. 2015 Jan;73(1):70-81. doi: 10.1002/mrm.25198. Epub 2014 Mar 6.
PubMed 24604728Bagnato F, Jeffries N, Richert ND, Stone RD, Ohayon JM, McFarland HF, Frank JA. Evolution of T1 black holes in patients with multiple sclerosis imaged monthly for 4 years. Brain. 2003 Aug;126(Pt 8):1782-9. doi: 10.1093/brain/awg182. Epub 2003 Jun 23.
PubMed 12821527Barkhof F, Bruck W, De Groot CJ, Bergers E, Hulshof S, Geurts J, Polman CH, van der Valk P. Remyelinated lesions in multiple sclerosis: magnetic resonance image appearance. Arch Neurol. 2003 Aug;60(8):1073-81. doi: 10.1001/archneur.60.8.1073.
PubMed 12925362Barkhof F, Calabresi PA, Miller DH, Reingold SC. Imaging outcomes for neuroprotection and repair in multiple sclerosis trials. Nat Rev Neurol. 2009 May;5(5):256-66. doi: 10.1038/nrneurol.2009.41.
PubMed 19488083Bernini GP, Lucarini AR, Franchi F, Salvetti A. Humoral effects of metoclopramide and domperidone in normal subjects and in hypertensive patients. J Endocrinol Invest. 1988 Nov;11(10):711-6. doi: 10.1007/BF03350925.
PubMed 2852692Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology. 2003 Dec 9;61(11):1528-32. doi: 10.1212/01.wnl.0000096175.39831.21.
PubMed 14663037Filippi M, Rovaris M, Rocca MA, Sormani MP, Wolinsky JS, Comi G; Eurpoean/Canadian Glatiramer Acetate Study Group. Glatiramer acetate reduces the proportion of new MS lesions evolving into "black holes". Neurology. 2001 Aug 28;57(4):731-3. doi: 10.1212/wnl.57.4.731.
PubMed 11524494Trapp BD, Peterson J, Ransohoff RM, Rudick R, Mork S, Bo L. Axonal transection in the lesions of multiple sclerosis. N Engl J Med. 1998 Jan 29;338(5):278-85. doi: 10.1056/NEJM199801293380502.
PubMed 9445407Bjartmar C, Kidd G, Mork S, Rudick R, Trapp BD. Neurological disability correlates with spinal cord axonal loss and reduced N-acetyl aspartate in chronic multiple sclerosis patients. Ann Neurol. 2000 Dec;48(6):893-901.
PubMed 11117546Metz LM, Zhang Y, Yeung M, Patry DG, Bell RB, Stoian CA, Yong VW, Patten SB, Duquette P, Antel JP, Mitchell JR. Minocycline reduces gadolinium-enhancing magnetic resonance imaging lesions in multiple sclerosis. Ann Neurol. 2004 May;55(5):756. doi: 10.1002/ana.20111. No abstract available.
PubMed 15122721Sloka S, Metz LM, Hader W, Starreveld Y, Yong VW. Reduction of microglial activity in a model of multiple sclerosis by dipyridamole. J Neuroinflammation. 2013 Jul 18;10:89. doi: 10.1186/1742-2094-10-89.
PubMed 23866809Chandran S, Hunt D, Joannides A, Zhao C, Compston A, Franklin RJ. Myelin repair: the role of stem and precursor cells in multiple sclerosis. Philos Trans R Soc Lond B Biol Sci. 2008 Jan 12;363(1489):171-83. doi: 10.1098/rstb.2006.2019.
PubMed 17282989Franklin RJ. Why does remyelination fail in multiple sclerosis? Nat Rev Neurosci. 2002 Sep;3(9):705-14. doi: 10.1038/nrn917.
PubMed 12209119Zhao C, Fancy SP, Kotter MR, Li WW, Franklin RJ. Mechanisms of CNS remyelination--the key to therapeutic advances. J Neurol Sci. 2005 Jun 15;233(1-2):87-91. doi: 10.1016/j.jns.2005.03.008.
PubMed 15949498Gregg C, Shikar V, Larsen P, Mak G, Chojnacki A, Yong VW, Weiss S. White matter plasticity and enhanced remyelination in the maternal CNS. J Neurosci. 2007 Feb 21;27(8):1812-23. doi: 10.1523/JNEUROSCI.4441-06.2007.
PubMed 17314279
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02493049
- Acronym / sponsor ID
- DOM-RRMS-01
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Domperidone, Relapsing-Remitting MS, Demyelinating disease, Remyelination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Study start
- Aug 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 9 Jul 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 first major objective of this pilot trial is to demonstrate that it is possible to study myelin repair in relapsing-remitting multiple sclerosis (RRMS) patients with enhancing lesions on MRI by using advanced imaging techniques. To demonstrate that this is possible the investigators will recruit 24 RRMS patients who are being treated with standard disease modifying therapy (DMT) and have new lesions identified on clinically indicated brain MRI scans and measure myelin repair at 16 and 32 weeks using MRI measures of myelin repair. The second major objective is to determine how much repair occurs in participants treated with domperidone compared with those who are not treated. This will allow us to design larger trials to confirm that domperidone improves repair. The study will also confirm the safety and tolerability of domperidone in RRMS, determine circulating prolactin levels during dosing with domperidone 10mg three times daily in people with RRMS, and explore the impact of other clinical factors (such as age) on lesion repair.
In addition, blood will be collected to test for metabolomics and the investigators will bank blood for future study of biomarkers that can help the investigators better understand MS. Metabolomics is an experimental test where changes in the pattern of the chemicals in blood cells are compared at different time points (during and after inflammation). There will be random changes but changes that are common in most study participants may help identify chemicals that signal stages in injury or repair. The investigators will also compare the pattern of change in those with the best repair to those with the worst repair. This may help identify a chemical that is associated with better or worse repair and help develop new treatment strategies. There are currently no blood tests that help in the diagnosis of MS, help determine which drug a person will respond to, or help determine a person's expected MS outcome. Any such tests would be considered biomarkers.
Detailed description
Primary Objectives:
- To demonstrate that the investigators can recruit DMT treated RRMS patients who have breakthrough enhancing lesions identified on clinically indicated monitoring brain MRI scans and measure lesion repair over 32 weeks.
- To obtain estimates of the magnitude and variability of lesion repair in DMT treated RRMS patients who are taking add-on domperidone, or no add-on treatment. The investigators will evaluate three MRI measures [texture analysis, diffusion tensor imaging (DTI), and magnetization transfer imaging (MTI)] for their ability to measure repair within acute enhancing lesions in RRMS. They will also evaluate repair at 16 and 32 weeks. These outcomes will aid in the development of future trials.
No therapies have yet been shown to improve lesion repair, and there is no accepted trial model to evaluate lesion repair in humans. Therefore, the investigators anticipate that the data from this trial will inform the design of future phase 2 trials of therapies to promote lesion repair in MS.
Secondary Objectives:
- To determine the safety and tolerability of domperidone in RRMS
- To determine serum prolactin levels during dosing with domperidone 10mg tid in this population
- To explore metabolomic profiling during lesion repair.
- To explore the impact of the following variables on lesion repair: prolactin level at 6 weeks, concurrent use of each type of DMT, Vitamin D and B12 levels at baseline, patient clinical characteristics (MS duration, EDSS), imaging characteristics (T2 lesion volume, enhancing lesion volume), patient demographics and behaviours (age, sex, smoking status).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Domperidone | Experimental | Drug: DomperidoneAdd on oral Domperidone 10 mg, three times daily. Target dose:30mg daily. Duration: 16 weeks |
| No add on treatment | No intervention | –No add on treatment. Control group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants must be between age 18 and 60 years.
- Sexually active men and women of child-bearing potential, defined as those who are not postmenopausal (24 consecutive months) or permanently sterilised, must agree to use adequate contraception. Adequate contraception is defined as methods of birth control which result in a low failure rate [i.e. less than 1% per year] when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), barrier contraceptives, sexual abstinence or vasectomised partner. Adequate contraception is required during domperidone treatment and for one month after stopping treatment.
- Participants must have MS defined according to the McDonald criteria (Polman et al. 2011).
- Participants must have RRMS according to Lublin et al. (2014).
- Participants must have been treated with a stable approved dose of glatiramer acetate, interferon-beta, fingolimod, dimethyl fumarate, or teriflunomide for at least 6 months.
Key exclusion criteria (15 listed)
- Participants who are pregnant or breastfeeding
- Participants in whom it is expected that their current DMT will be discontinued within 16 weeks. Indicators of likely discontinuation will include poor DMT tolerance, a wish by the participant to discontinue the DMT, or a history of poor clinical response to the current DMT (such as a relapse within the previous year while on the current DMT)
- Participants who have a long QT interval, defined as corrected QT interval of more than 470 msec in men and more than 450 msec in women, on screening ECG.
- Participants with known long-QT syndrome or known cardiac arrhythmia.
- Participants who currently or previously have been treated with natalizumab.
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 |
|---|---|---|
| DomperidoneAlso: domperidone maleateAddition of Domperidone to current Disease Modifying Therapy. | Drug | Domperidone |
Primary outcome
Measures of repair within enhancing T1 MRI lesions
Time frame: up to 32 weeks
Texture analysis, Diffusion Tensor Imaging (DTI) and Magnetization Transfer Imaging (MTI) will be used. This is a pilot study so the investigators are measuring repair at 2 time points and with 3 imaging methods to aid in the design of future studies.
2 secondary outcomes
Number and type of adverse events over the 16 week treatment period.
Time frame: at 6 and 16 weeks
Serum Prolactin Levels at both 6 and 16 weeks
Time frame: at 6 and 16 weeks
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 8 Oct 2019.
- Background: PubMed 24604728Alonso-Ortiz E, Levesque IR, Pike GB. MRI-based myelin water imaging: A technical review. Magn Reson Med. 2015 Jan;73(1):70-81. doi: 10.1002/mrm.25198. Epub 2014 Mar 6.
- Background: PubMed 12821527Bagnato F, Jeffries N, Richert ND, Stone RD, Ohayon JM, McFarland HF, Frank JA. Evolution of T1 black holes in patients with multiple sclerosis imaged monthly for 4 years. Brain. 2003 Aug;126(Pt 8):1782-9. doi: 10.1093/brain/awg182. Epub 2003 Jun 23.
- Background: PubMed 12925362Barkhof F, Bruck W, De Groot CJ, Bergers E, Hulshof S, Geurts J, Polman CH, van der Valk P. Remyelinated lesions in multiple sclerosis: magnetic resonance image appearance. Arch Neurol. 2003 Aug;60(8):1073-81. doi: 10.1001/archneur.60.8.1073.
- Background: PubMed 19488083Barkhof F, Calabresi PA, Miller DH, Reingold SC. Imaging outcomes for neuroprotection and repair in multiple sclerosis trials. Nat Rev Neurol. 2009 May;5(5):256-66. doi: 10.1038/nrneurol.2009.41.
- Background: PubMed 2852692Bernini GP, Lucarini AR, Franchi F, Salvetti A. Humoral effects of metoclopramide and domperidone in normal subjects and in hypertensive patients. J Endocrinol Invest. 1988 Nov;11(10):711-6. doi: 10.1007/BF03350925.
- Background: PubMed 14663037Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology. 2003 Dec 9;61(11):1528-32. doi: 10.1212/01.wnl.0000096175.39831.21.
- Background: PubMed 11524494Filippi M, Rovaris M, Rocca MA, Sormani MP, Wolinsky JS, Comi G; Eurpoean/Canadian Glatiramer Acetate Study Group. Glatiramer acetate reduces the proportion of new MS lesions evolving into "black holes". Neurology. 2001 Aug 28;57(4):731-3. doi: 10.1212/wnl.57.4.731.
- Background: PubMed 9445407Trapp BD, Peterson J, Ransohoff RM, Rudick R, Mork S, Bo L. Axonal transection in the lesions of multiple sclerosis. N Engl J Med. 1998 Jan 29;338(5):278-85. doi: 10.1056/NEJM199801293380502.
- Background: PubMed 11117546Bjartmar C, Kidd G, Mork S, Rudick R, Trapp BD. Neurological disability correlates with spinal cord axonal loss and reduced N-acetyl aspartate in chronic multiple sclerosis patients. Ann Neurol. 2000 Dec;48(6):893-901.
- Background: PubMed 15122721Metz LM, Zhang Y, Yeung M, Patry DG, Bell RB, Stoian CA, Yong VW, Patten SB, Duquette P, Antel JP, Mitchell JR. Minocycline reduces gadolinium-enhancing magnetic resonance imaging lesions in multiple sclerosis. Ann Neurol. 2004 May;55(5):756. doi: 10.1002/ana.20111. No abstract available.
- Background: PubMed 23866809Sloka S, Metz LM, Hader W, Starreveld Y, Yong VW. Reduction of microglial activity in a model of multiple sclerosis by dipyridamole. J Neuroinflammation. 2013 Jul 18;10:89. doi: 10.1186/1742-2094-10-89.
- Background: PubMed 17282989Chandran S, Hunt D, Joannides A, Zhao C, Compston A, Franklin RJ. Myelin repair: the role of stem and precursor cells in multiple sclerosis. Philos Trans R Soc Lond B Biol Sci. 2008 Jan 12;363(1489):171-83. doi: 10.1098/rstb.2006.2019.
- Individual participant dataSharing planned: No. consent to share IPD was not obtained so we cannot share
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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.
Luanne M Metz, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Domperidone in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Calgary at 1 site in Canada.
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 10 inclusion and 15 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 8 Oct 2019. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Measures of repair within enhancing T1 MRI lesions (time frame: up to 32 weeks). 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 NCT02493049, which also lists 21 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 Oct 2019.