Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
262 participants
INTERVENTIONAL
2004-10-31
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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HP184
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
sanofi-aventis administrative Australia & New-Zealand administrative office
Macquarie Park, New South Wales, , Australia
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Guildford Surrey, , United Kingdom
Countries
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Other Identifiers
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HP184B/2002
Identifier Type: -
Identifier Source: secondary_id
DRI6213
Identifier Type: -
Identifier Source: org_study_id