Chronic spinal cord injury
Conditions
Interventions
Product Code: HP184
Pharmaceutical Form: Film-coated tablet
CAS Number: 119229-64-0
Current Sponsor code: HP184
Other descriptive name:
Sponsors
Aventis Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female subjects with incomplete (traumatic), chronic (defined as 18 month 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 • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To determine the safety and tolerability of HP184 when administered for 24 weeks in CSCI subjects as well as the effect of HP184 on the following variables: • Voluntary movement in additional muscle groups (not included in ASIA exam) • Walking Index of Spinal Cord Injury (WISCI) • Neopraxis gait assessment • Ashworth Spasticity scale • ASIA sensory examination • SCIM • Patient Reported Outcome (PRO) ;Main Objective: To evaluate the effect of HP184 as compared to placebo on total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24 in subjects with CSCI.; Primary end point(s): Response rate using change from Baseline of = 6 points in total motor score of ASIA manual motor test at Week 24. | — |
Countries
Germany, United Kingdom
Outcome results
None listed