Multiple SclerosisPhase 2NCT00298662
Combination Therapy of Betaseron-Prograf in Multiple Sclerosis
A Phase 2 study testing Interferon beta-1b and Tacrolimus in people with Multiple Sclerosis, run by Clinique de sclérose en plaques et neuromusculaire de l'Outaouais at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of a combination of interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®) in patients suffering from multiple sclerosis (MS) who have failed treatment with currently approved drugs for MS Prograf is an immunosuppressant that weakens the immune… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b and Tacrolimus
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2003to Sep 2006
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- relapsing-remitting or secondary-progressive multiple sclerosis
- patients who have failed treatment with approved immunomodulator drugs (having experienced same or higher annual relapse rate or having experinced progression on the EDSS scale)
- Expanded Disability Status Scale (EDSS) score less than 7.0
Who cannot join
- any of the following conditions: diabetes mellitus, uncontrolled hypertension, active infection or viral diseases
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique de sclérose en plaques et neuromusculaire
Gatineau, Quebec, J8Y 1W7
About this study
Official title: A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents
The purpose of the study is to evaluate the safety and tolerability of a combination of interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®) in patients suffering from multiple sclerosis (MS) who have failed treatment with currently approved drugs for MS
Prograf is an immunosuppressant that weakens the immune reactions responsible to protect the organism against infections. It is currently available on the market for patients who have received an organ transplant, to prevent rejection. Because of its effect on the immune system, theoretically, Prograf should exert a significant effect in MS. It has been tried in a small number of MS patients at a lower dose than the one used in organ transplant, however the results of the study did not allow to draw definite conclusions on its safety and efficacy in MS.
Read more
Betaseron is approved in Canada for the reduction of the frequency of relapses in patients with relapsing-remitting MS and for the slowing of progression and reduction of the frequency of relapses in patients with secondary-progressive MS. The combination of Betaseron and Prograf may result in an additive effect or an increase in the actions of the drugs. However, the combination of the two drugs has never been studied.
The aim of this study is to see how well the combination of Betaseron and Prograf is tolerated by patients with MS. The side effects of the treatment, if any, will be followed. In addition, the efficacy of the combination will be evaluated.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b and Tacrolimus
- Keywords
- Multiple Sclerosis, Betaseron-Prograf, patients of Multiple Sclerosis, Secondary Progressive type, Relapsing-Remitting type
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b and TacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
relapse rate
number of T2 godolinium enhencing lesions on MRI
expanded disease severity score (EDSS)
multiple sclerosis functional composite(MSFC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startFeb 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Clinique de sclérose en plaques et neuromusculaire de l'Outaouais
- Sponsor type
- University, hospital or other
- Investigators
- François Jacques, Principal investigator, Multiple Sclerosis Clinic - Hull Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298662
- Sponsor's protocol ID
- 137-020826
- Status last verified
- Sep 2005
- First submitted
- 2 Mar 2006
- Last updated
- 3 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents
- ClinicalTrials.gov ID
- NCT00298662
- Acronym / sponsor ID
- 137-020826
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Betaseron-Prograf, patients of Multiple Sclerosis, Secondary Progressive type, Relapsing-Remitting type
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Clinique de sclérose en plaques et neuromusculaire de l'OutaouaisUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Sep 2006
- First posted
- 3 Mar 2006 (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 purpose of the study is to evaluate the safety and tolerability of a combination of interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®) in patients suffering from multiple sclerosis (MS) who have failed treatment with currently approved drugs for MS
Prograf is an immunosuppressant that weakens the immune reactions responsible to protect the organism against infections. It is currently available on the market for patients who have received an organ transplant, to prevent rejection. Because of its effect on the immune system, theoretically, Prograf should exert a significant effect in MS. It has been tried in a small number of MS patients at a lower dose than the one used in organ transplant, however the results of the study did not allow to draw definite conclusions on its safety and efficacy in MS.
Betaseron is approved in Canada for the reduction of the frequency of relapses in patients with relapsing-remitting MS and for the slowing of progression and reduction of the frequency of relapses in patients with secondary-progressive MS. The combination of Betaseron and Prograf may result in an additive effect or an increase in the actions of the drugs. However, the combination of the two drugs has never been studied.
The aim of this study is to see how well the combination of Betaseron and Prograf is tolerated by patients with MS. The side effects of the treatment, if any, will be followed. In addition, the efficacy of the combination will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- relapsing-remitting or secondary-progressive multiple sclerosis
- patients who have failed treatment with approved immunomodulator drugs (having experienced same or higher annual relapse rate or having experinced progression on the EDSS scale)
- Expanded Disability Status Scale (EDSS) score less than 7.0
Key exclusion criteria (1 listed)
- any of the following conditions: diabetes mellitus, uncontrolled hypertension, active infection or viral diseases
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 |
|---|---|---|
| Interferon beta-1b and Tacrolimus | Drug | – |
Primary outcome
safety and tolerability
relapse rate
number of T2 godolinium enhencing lesions on MRI
expanded disease severity score (EDSS)
multiple sclerosis functional composite(MSFC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2006.
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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.
François Jacques principal investigator
Multiple Sclerosis Clinic - Hull Hospital
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 Interferon beta-1b and Tacrolimus in people with Multiple Sclerosis, run by Clinique de sclérose en plaques et neuromusculaire de l'Outaouais 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 3 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: status not confirmed, as of the sponsor's last update on 3 Mar 2006. 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?
Results are not available in the source record.
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?
safety and tolerability. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2006.