Multiple SclerosisPhase 1/2NCT01864941
Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients
A Phase 1/2 study testing Catheter venography with balloon venoplasty and Catheter venography with balloon venoplasty and balloon in people with Multiple Sclerosis, run by University of British Columbia at 4 sites in Canada.
Trial summary
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Catheter venography with balloon venoplasty and Catheter venography with balloon venoplasty and balloon
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 4 sitesCanada
- Study dates
- May 2013to 1 Aug 2017
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010
- Age 18 to 65 years inclusive
- Neurostatus (EDSS) score at screening from 0 to 6.5
- Fulfill ultrasound criteria for CCSVI
Who cannot join
- Previous venoplasty and/or stenting of extra cranial venous system
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 4M1
CHU de Québec - Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Vancouver Coastal Health - University of British Columbia Hospital
Vancouver, British Columbia, V6T 2B5
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.
Read the detailed description
Overview of study objectives are:
- To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis (MS).
- To determine the short term and long term impact on validated patient measures and by physician and radiologic reported MS outcomes.
- To determine the short term and long term recurrence rate of CCSVI for veins that have been treated with venoplasty
- Conditions
- Multiple Sclerosis
- Being tested
- Catheter venography with balloon venoplasty, Catheter venography with balloon venoplasty and balloon
- Keywords
- Multiple Sclerosis, MS, CCSVI, Zamboni, catheter venography, balloon angioplasty
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter venography with balloon venoplastyProcedure or surgery
All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure.
Catheter venography with balloon venoplasty and balloonDevice
| Study group | Role | What they receive |
|---|---|---|
| Catheter Venography & Balloon Venoplasty | Active comparator | Patients will undergo catheter venography with balloon venoplasty procedure. Receives: Procedure: Catheter venography with balloon venoplasty; Device: Catheter venography with balloon venoplasty and balloon |
| Catheter Venography Only | Sham comparator | Patients will undergo catheter venography only. Receives: Procedure: Catheter venography with balloon venoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis (MS) patients with CCSVI as measured by adverse events occurring within 48 weeks of the procedure.
Measured: 48 weeks
Secondary outcomes (4)
Clinical Outcome
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by patient reported quality of life, pain and fatigue scales 48 weeks after the procedure.
Measured: 48 weeks
Clinical Outcome
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure.
Measured: 48 weeks
Clinical Outcome
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure.
Measured: 48 weeks
Clinical Outcome
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startMay 2013
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Multiple Sclerosis Society of Canada
- Responsible party
- Principal investigator, Anthony Traboulsee, University of British Columbia
- Investigators
- Anthony Traboulsee, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864941
- Sponsor's protocol ID
- H12-01153
- Status last verified
- Apr 2018
- First submitted
- 13 May 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Traboulsee AL, Machan L, Girard JM, Raymond J, Vosoughi R, Hardy BW, Emond F, Gariepy JL, Bone JN, Siskin G, Klass D, Isserow S, Illes J, Sadovnick AD, Li DK. Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial. Neurology. 2018 Oct 30;91(18):e1660-e1668. doi: 10.1212/WNL.0000000000006423. Epub 2018 Sep 28.
PubMed 30266886
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT01864941
- Acronym / sponsor ID
- H12-01153
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, CCSVI, Zamboni, catheter venography, balloon angioplasty
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Multiple Sclerosis Society of Canada
- Study start
- May 2013
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 30 May 2013 (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.
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.
Detailed description
Overview of study objectives are:
- To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis (MS).
- To determine the short term and long term impact on validated patient measures and by physician and radiologic reported MS outcomes.
- To determine the short term and long term recurrence rate of CCSVI for veins that have been treated with venoplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter Venography & Balloon Venoplasty | Active comparator | Procedure: Catheter venography with balloon venoplasty, Device: Catheter venography with balloon venoplasty and balloonPatients will undergo catheter venography with balloon venoplasty procedure. |
| Catheter Venography Only | Sham comparator | Procedure: Catheter venography with balloon venoplastyPatients will undergo catheter venography only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010
- Age 18 to 65 years inclusive
- Neurostatus (EDSS) score at screening from 0 to 6.5
- Fulfill ultrasound criteria for CCSVI
Key exclusion criteria (1 listed)
- Previous venoplasty and/or stenting of extra cranial venous system
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 |
|---|---|---|
| Catheter venography with balloon venoplastyAll eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure. | Procedure or surgery | Catheter Venography & Balloon Venoplasty, Catheter Venography Only |
| Catheter venography with balloon venoplasty and balloon | Device | Catheter Venography & Balloon Venoplasty |
Primary outcome
Adverse Events
Time frame: 48 weeks
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis (MS) patients with CCSVI as measured by adverse events occurring within 48 weeks of the procedure.
4 secondary outcomes
Clinical Outcome
Time frame: 48 weeks
Clinical Outcome
Time frame: 48 weeks
Clinical Outcome
Time frame: 48 weeks
Clinical Outcome
Time frame: 48 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 17 Apr 2018.
- Derived from this study: PubMed 30266886Traboulsee AL, Machan L, Girard JM, Raymond J, Vosoughi R, Hardy BW, Emond F, Gariepy JL, Bone JN, Siskin G, Klass D, Isserow S, Illes J, Sadovnick AD, Li DK. Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial. Neurology. 2018 Oct 30;91(18):e1660-e1668. doi: 10.1212/WNL.0000000000006423. Epub 2018 Sep 28.
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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.
Anthony Traboulsee, MD study director
University of British Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Catheter venography with balloon venoplasty and Catheter venography with balloon venoplasty and balloon in people with Multiple Sclerosis, run by University of British Columbia at 4 sites 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 4 inclusion and 1 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 17 Apr 2018. 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 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Events (time frame: 48 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 NCT01864941, which also lists 1 linked publication.
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 17 Apr 2018.