Overview

HP184 in Chronic Spinal Cord Injury Subjects

Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
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.