Spinal Cord InjuryPhase 2NCT00093275
HP184 in Chronic Spinal Cord Injury Subjects
A Phase 2 study testing HP184 in people with Spinal Cord Injury, run by Sanofi at 5 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- HP184
- How many people
- 262 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Oct 2004to Dec 2005
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects with incomplete (traumatic), chronic (defined as 18 months or more post spinal cord injury) SCI aged 18 to 65 years
- CSCI must be categorized in classes C or D in the ASIA impairment scale. (C = Incomplete impairment with motor function preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete impairment with motor function preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade more than or equal to 3).
- The level of the SCI must be between C4 and T10 (neurological)
- Subject has a measurable range of motion at the hips, knees and ankles and possesses potential propulsive activity (i.e. no functional contractures)
- Female subjects of childbearing potential (those who are not surgically sterile or who are less than 2 years postmenopausal) must be using two forms of birth control, including a primary and a secondary form and have a negative pregnancy test immediately prior to treatment. Primary forms of contraception include: tubal ligation, partner's vasectomy, intrauterine devices, birth control pills, and topical/injectable/implantable/insertable hormonal birth control products. Secondary forms of contraception include diaphragms, latex condoms and cervical caps; each must be used with a spermicide.
Who cannot join
- Any clinical evidence of recent fracture(s) within the last six months prior to study start.
- Any history of Multiple Sclerosis or peripheral demyelinating disease or neuromuscular disorder.
- Heart rate of less than 38 or greater than 100
- Ashworth spasticity score of 0/4 or 4/4 at the hip or knee.
- Subject whose medical condition requires mechanical ventilation.
- Lower motor neuron injury, such as those with conus medullaris or cauda equina injuries.
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- Subject with lower extremity amputation or proximal femorectomy.
- Subject with pressure ulcers stages 3 and 4.
- Subject medically or mentally unstable in judgment of Investigator.
- Subject on tricyclic antidepressants such as nortriptyline, amitriptyline and imipramine.
- Subject with ASIA motor score of greater than or equal to 92.
- Subject with ASIA sensory score of greater than or equal to 200.
- Subject with history of seizure within 2 years prior to study start.
- Subjects who have participated in a clinical trial involving investigational medication within 30 days prior to administration of HP184 or placebo.
- Female subjects with positive urine pregnancy test.
- Female subjects who are breast feeding.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
Australia1 site
sanofi-aventis administrative Australia & New-Zealand administrative office
Macquarie Park, New South Wales
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: A Phase II, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of HP184 Administered Orally Once Daily for Twenty-Four Weeks in Adult Subjects With Chronic Spinal Cord Injury (CSCI)
The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).
- Conditions
- Spinal Cord Injury
- Being tested
- HP184
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP184Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.
Secondary outcomes (1)
Safety evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2004 (estimated)
- Study startOct 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Double blind
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093275
- Sponsor's protocol ID
- DRI6213
- Other IDs
- HP184B/2002
- Status last verified
- Aug 2008
- First submitted
- 5 Oct 2004
- Last updated
- 21 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of HP184 Administered Orally Once Daily for Twenty-Four Weeks in Adult Subjects With Chronic Spinal Cord Injury (CSCI)
- ClinicalTrials.gov ID
- NCT00093275
- Acronym / sponsor ID
- DRI6213
- Conditions
- Spinal Cord Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 7 Oct 2004 (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 determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects with incomplete (traumatic), chronic (defined as 18 months or more post spinal cord injury) SCI aged 18 to 65 years
- CSCI must be categorized in classes C or D in the ASIA impairment scale. (C = Incomplete impairment with motor function preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete impairment with motor function preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade more than or equal to 3).
- The level of the SCI must be between C4 and T10 (neurological)
- Subject has a measurable range of motion at the hips, knees and ankles and possesses potential propulsive activity (i.e. no functional contractures)
- Female subjects of childbearing potential (those who are not surgically sterile or who are less than 2 years postmenopausal) must be using two forms of birth control, including a primary and a secondary form and have a negative pregnancy test immediately prior to treatment. Primary forms of contraception include: tubal ligation, partner's vasectomy, intrauterine devices, birth control pills, and topical/injectable/implantable/insertable hormonal birth control products. Secondary forms of contraception include diaphragms, latex condoms and cervical caps; each must be used with a spermicide.
Key exclusion criteria (16 listed)
- Any clinical evidence of recent fracture(s) within the last six months prior to study start.
- Any history of Multiple Sclerosis or peripheral demyelinating disease or neuromuscular disorder.
- Heart rate of less than 38 or greater than 100
- Ashworth spasticity score of 0/4 or 4/4 at the hip or knee.
- Subject whose medical condition requires mechanical ventilation.
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 |
|---|---|---|
| HP184 | Drug | – |
Primary outcome
Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.
1 secondary outcome
Safety evaluation.
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 21 Aug 2008.
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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.
ICD CSD study director
Sanofi
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HP184 in people with Spinal Cord Injury, run by Sanofi at 5 sites in 5 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 5 inclusion and 16 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 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Germany, India, United Kingdom. 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?
Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.. 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 21 Aug 2008.