Multiple SclerosisPhase 2NCT00811902
Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
A Phase 2 study testing Nerispirdine in people with Multiple Sclerosis, run by Sanofi at 7 sites in 7 countries.
Trial summary
The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS). Secondary objectives: To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Nerispirdine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Dec 2008to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically definite MS (according to McDonald criteria),
Who cannot join
- Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit.
- Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device,
- Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.
- Female patients who are either pregnant or breastfeeding.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis.
The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS).
Secondary objectives:
- To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the Study Investigator
- To assess the safety and tolerance of nerispirdine
- To evaluate the pharmacokinetics (PK) parameters of nerispirdine
Read the detailed description
Total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period
- Conditions
- Multiple Sclerosis
- Being tested
- Nerispirdine, placebo
- Keywords
- Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerispirdineDrug
Also called HP184
tablet, oral administration
placeboDrug
tablet, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Nerispirdine 50mg | Experimental | Nerispirdine 50mg once daily for 14 weeks Receives: Drug: Nerispirdine |
| Nerispirdine 100mg | Experimental | Nerispirdine 100mg once daily for 14 weeks Receives: Drug: Nerispirdine |
| Nerispirdine 200mg | Experimental | Nerispirdine 200mg once daily for 14 weeks Receives: Drug: Nerispirdine |
| Placebo | Placebo comparator | Placebo for Nerispirdine once daily for 14 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)
Measured: 14 weeks
Secondary outcomes (1)
Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2010
- Study completionMar 2010
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.
- More trials run by SanofiThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811902
- Sponsor's protocol ID
- DRI10566
- Other IDs
- 2008-001999-67, 2008
- Status last verified
- Jan 2016
- First submitted
- 18 Dec 2008
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT00811902
- Acronym / sponsor ID
- DRI10566
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Dec 2008 (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 primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS).
Secondary objectives:
- To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the Study Investigator
- To assess the safety and tolerance of nerispirdine
- To evaluate the pharmacokinetics (PK) parameters of nerispirdine
Detailed description
Total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nerispirdine 50mg | Experimental | Drug: NerispirdineNerispirdine 50mg once daily for 14 weeks |
| Nerispirdine 100mg | Experimental | Drug: NerispirdineNerispirdine 100mg once daily for 14 weeks |
| Nerispirdine 200mg | Experimental | Drug: NerispirdineNerispirdine 200mg once daily for 14 weeks |
| Placebo | Placebo comparator | Drug: placeboPlacebo for Nerispirdine once daily for 14 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically definite MS (according to McDonald criteria),
Key exclusion criteria (5 listed)
- Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit.
- Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device,
- Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.
- Female patients who are either pregnant or breastfeeding.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| NerispirdineAlso: HP184tablet, oral administration | Drug | Nerispirdine 100mg, Nerispirdine 200mg, Nerispirdine 50mg |
| placebotablet, oral administration | Drug | Placebo |
Primary outcome
Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)
Time frame: 14 weeks
1 secondary outcome
Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)
Time frame: 14 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 26 Feb 2016.
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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.
Clinical Sciences & Operations study director
Sanofi
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nerispirdine in people with Multiple Sclerosis, run by Sanofi at 7 sites in 7 countries.
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 5 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 26 Feb 2016. 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 United States, Canada, Finland, France, Germany and 2 more countries. 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 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?
Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT) (time frame: 14 weeks). 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 26 Feb 2016.