Secondary Progressive Multiple SclerosisPhase 3NCT00146159
Study Evaluating Mitoxantrone in Multiple Sclerosis
A Phase 3 study testing Mitoxantrone in people with Secondary Progressive Multiple Sclerosis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 7 sites in Germany.
Trial summary
The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- What is being tested?
- Mitoxantrone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 7 sitesGermany
- Study dates
- Mar 2005to Sep 2007
- Phase
- Phase 3
- 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
- Secondary progressive MS in an active stage
- EDSS between 3 and 6
Who cannot join
- Benign or primary progressive MS
- Patients with cardiac risk factors
- Patients who have already received mitoxantrone
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Study site
Berg, D-82335
Study site
Berlin, D-13347
Study site
Düsseldorf, D-40225
Study site
Düsseldorf, D-40479
Study site
Giessen, D-35385
Study site
Marburg, D-35039
Study site
Wiesbaden, D-65191
About this study
Official title: A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis
The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.
- Conditions
- Secondary Progressive Multiple Sclerosis
- Being tested
- Mitoxantrone
- Keywords
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoxantroneDrug
dosage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1st group: 12 mg Mitoxantrone/m² Receives: Drug: Mitoxantrone |
| 2 | Experimental | 2nd group: 9mg Mitoxantrone/m² Receives: Drug: Mitoxantrone |
| 3 | Experimental | 3rd group: 5mg Mitoxantrone/m² Receives: Drug: Mitoxantrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)
Measured: 3 years
deterioration, change of ambulation index, time to first relapse requiring corticoid treatment
Measured: 3 years
Secondary outcomes (1)
derivations of EDSS and relapses; MRI (baseline, 2 years)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progressive 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146159
- Sponsor's protocol ID
- 0906E-100925
- Status last verified
- Dec 2007
- First submitted
- 1 Sep 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00146159
- Acronym / sponsor ID
- 0906E-100925
- Conditions
- Secondary Progressive Multiple Sclerosis
- Keywords
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Sep 2007 (actual)
- First posted
- 5 Sep 2005 (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 this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mitoxantrone1st group: 12 mg Mitoxantrone/m² |
| 2 | Experimental | Drug: Mitoxantrone2nd group: 9mg Mitoxantrone/m² |
| 3 | Experimental | Drug: Mitoxantrone3rd group: 5mg Mitoxantrone/m² |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Secondary progressive MS in an active stage
- EDSS between 3 and 6
Key exclusion criteria (3 listed)
- Benign or primary progressive MS
- Patients with cardiac risk factors
- Patients who have already received mitoxantrone
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 |
|---|---|---|
| Mitoxantronedosage | Drug | 1, 2, 3 |
Primary outcome
3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)
Time frame: 3 years
deterioration, change of ambulation index, time to first relapse requiring corticoid treatment
Time frame: 3 years
1 secondary outcome
derivations of EDSS and relapses; MRI (baseline, 2 years)
Time frame: 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitoxantrone in people with Secondary Progressive Multiple Sclerosis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 7 sites in Germany.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. 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?
3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) (time frame: 3 years). The study lists 2 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 28 Dec 2007.