Multiple SclerosisPhase 2NCT00772525
Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis
A Phase 2 study testing Nerispirdine in people with Multiple Sclerosis and Optic Nerve, run by Sanofi at 1 site in United States.
Trial summary
The primary objective of the study was to evaluate the effect of Nerispirdine (50 mg or 400 mg) and placebo given orally as a single dose once a week in crossover design on latency of Visual Evoked Potentials (VEP) P100 in optic nerves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Optic Nerve, Neuritis
- 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
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2009
- 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 (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS who have had a past history of Optic Neuritis.
Who cannot join
- Multiple sclerosis exacerbation within 60 days of the Screening Visit and the relapse involved the visual fields or visual acuity
- No eye with appropriate degree of lesions for this study as defined by criteria based on degree of visual acuity deficit, refractive error, VEP P100 latency and average retinal nerve fiber layer thickness of as measured by Optical Coherence Tomography (OCT)
- Any MS-unrelated prior ophthalmological impairment (eg, compressive, ischemic, toxic, or nutritional optic neuropathies, Leber's hereditary optic atrophy)
- Previously exposed to 3,4-diaminopyridine or 4-aminopyridine
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrave Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis
The primary objective of the study was to evaluate the effect of Nerispirdine (50 mg or 400 mg) and placebo given orally as a single dose once a week in crossover design on latency of Visual Evoked Potentials (VEP) P100 in optic nerves.
Secondary objectives included evaluation of the effect of Nerispirdine on VEP amplitude and other visual parameters including visual acuity and contrast, as well as evaluation of the safety and tolerability of Nerispirdine in patients with Multiple Sclerosis (MS).
Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence Tomography [OCT] and VEPs) were needed during the screening period for defining etiologic relationships (if non-MS related impairment) and for assessing the effect of treatment of age-related eye disease versus the MS-related vision impairment.
Read the detailed description
The crossover design included 3 treatment periods 1 week apart and 6 treatment sequences. Study participation were to be 5 weeks.
- Conditions
- Multiple Sclerosis, Optic Nerve, Neuritis
- Being tested
- Nerispirdine, Placebo
- Keywords
- Visual acuity, Contrast sensitivity, Visual Evoked Potentials, Optical Coherence Tomography
- Medical subject headings
- Multiple Sclerosis, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerispirdineDrug
Also called HP184
form: tablet
Route: oral
PlaceboDrug
form: tablet
Route: oral
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | placebo,1 day treatment period 1
50 mg Nerispirdine, 1 day treatment period 2
400 mg Nerispirdine, 1 day treatment period 3 Receives: Drug: Nerispirdine; Drug: Placebo |
| Sequence 2 | Experimental | placebo,1 day treatment period 1
400 mg Nerispirdine, 1 day treatment period 2
50 mg Nerispirdine, 1 day treatment period 3 Receives: Drug: Nerispirdine; Drug: Placebo |
| Sequence 3 | Experimental | 50 mg Nerispirdine, 1 day treatment period 1
placebo, 1 day treatment period 2
400 mg Nerispirdine, 1 day treatment period 3 Receives: Drug: Nerispirdine; Drug: Placebo |
| Sequence 4 | Experimental | 50 mg Nerispirdine, 1 day treatment period 1
400 mg Nerispirdine, 1 day treatment period 2
placebo, 1 day treatment period 3 Receives: Drug: Nerispirdine; Drug: Placebo |
| Sequence 5 | Experimental | 400 mg Nerispirdine, 1 day treatment period 1
placebo, 1 day treatment period 2
50 mg Nerispirdine, 1 day treatment period 3 Receives: Drug: Nerispirdine; Drug: Placebo |
| Sequence 6 | Experimental | 400 mg Nerispirdine, 1 day treatment period 1
50 mg Nerispirdine, 1 day treatment period 2
placebo, 1 day treatment period 3 Receives: Drug: Nerispirdine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Evoked Potential (P100) latency
Measured: pre-dose and post-dose of each treatment intake (3)
Secondary outcomes (3)
Pelli-Robson Contrast Sensitivity Score
Measured: pre-dose and post-dose of each treatment intake (3)
Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score
Measured: pre-dose and post-dose of each treatment intake (3)
Visual Evoked Potential (VEP) amplitude
Measured: pre-dose and post-dose of each treatment intake (3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionJun 2009
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert SERGOTT, MD, Principal investigator, Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772525
- Sponsor's protocol ID
- ACT10573
- Status last verified
- Jan 2016
- First submitted
- 13 Oct 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 Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00772525
- Acronym / sponsor ID
- ACT10573
- Conditions
- Multiple Sclerosis, Optic Nerve, Neuritis
- Keywords
- Visual acuity, Contrast sensitivity, Visual Evoked Potentials, Optical Coherence Tomography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Oct 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 of the study was to evaluate the effect of Nerispirdine (50 mg or 400 mg) and placebo given orally as a single dose once a week in crossover design on latency of Visual Evoked Potentials (VEP) P100 in optic nerves.
Secondary objectives included evaluation of the effect of Nerispirdine on VEP amplitude and other visual parameters including visual acuity and contrast, as well as evaluation of the safety and tolerability of Nerispirdine in patients with Multiple Sclerosis (MS).
Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence Tomography [OCT] and VEPs) were needed during the screening period for defining etiologic relationships (if non-MS related impairment) and for assessing the effect of treatment of age-related eye disease versus the MS-related vision impairment.
Detailed description
The crossover design included 3 treatment periods 1 week apart and 6 treatment sequences. Study participation were to be 5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Nerispirdine, Drug: Placeboplacebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3 |
| Sequence 2 | Experimental | Drug: Nerispirdine, Drug: Placeboplacebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3 |
| Sequence 3 | Experimental | Drug: Nerispirdine, Drug: Placebo50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3 |
| Sequence 4 | Experimental | Drug: Nerispirdine, Drug: Placebo50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3 |
| Sequence 5 | Experimental | Drug: Nerispirdine, Drug: Placebo400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3 |
| Sequence 6 | Experimental | Drug: Nerispirdine, Drug: Placebo400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3 |
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 (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS who have had a past history of Optic Neuritis.
Key exclusion criteria (5 listed)
- Multiple sclerosis exacerbation within 60 days of the Screening Visit and the relapse involved the visual fields or visual acuity
- No eye with appropriate degree of lesions for this study as defined by criteria based on degree of visual acuity deficit, refractive error, VEP P100 latency and average retinal nerve fiber layer thickness of as measured by Optical Coherence Tomography (OCT)
- Any MS-unrelated prior ophthalmological impairment (eg, compressive, ischemic, toxic, or nutritional optic neuropathies, Leber's hereditary optic atrophy)
- Previously exposed to 3,4-diaminopyridine or 4-aminopyridine
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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: HP184form: tablet Route: oral | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Placeboform: tablet Route: oral | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Visual Evoked Potential (P100) latency
Time frame: pre-dose and post-dose of each treatment intake (3)
3 secondary outcomes
Pelli-Robson Contrast Sensitivity Score
Time frame: pre-dose and post-dose of each treatment intake (3)
Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score
Time frame: pre-dose and post-dose of each treatment intake (3)
Visual Evoked Potential (VEP) amplitude
Time frame: pre-dose and post-dose of each treatment intake (3)
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.
Related trials for Multiple Sclerosis
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
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.
Robert SERGOTT, MD principal investigator
Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA
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 Nerispirdine in people with Multiple Sclerosis and Optic Nerve, run by Sanofi at 1 site in United States.
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 1 site in United States. 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?
Visual Evoked Potential (P100) latency (time frame: pre-dose and post-dose of each treatment intake (3)). 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.