Status:
COMPLETED
HP184 in Chronic Spinal Cord Injury Subjects
Lead Sponsor:
Sanofi
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00093275
Start Date
October 1 2004
End Date
December 1 2005
Last Update
August 21 2008
Active Locations (5)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
sanofi-aventis administrative Australia & New-Zealand administrative office
Macquarie Park, New South Wales, Australia
3
Sanofi-Aventis Administrative Office
Berlin, Germany
4
Sanofi-Aventis Administrative Office
Mumbai, India