The purpose of this study is to determine whether HP184 is effective in the treatment of
chronic spinal cord injury (CSCI).
- 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.
- Any clinical evidence of recent fracture(s) within the last six months prior to study
- Any history of Multiple Sclerosis or peripheral demyelinating disease or
- 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
- 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
- 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.