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Bridgewater, New Jersey 08807


Purpose:

The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).


Criteria:

Inclusion Criteria: - 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 Criteria: - 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.


NCT ID:

NCT00093275


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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