A phase II, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HP184 at 100, 200 and 400 mg doses administered orally once daily for twenty-four weeks in adult subjects with chronic spinal cord injury (CSCI)
- Conditions
- Chronic spinal cord injury
- Registration Number
- EUCTR2004-000763-98-GB
- Lead Sponsor
- Aventis Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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:<br> • Voluntary movement in additional muscle groups (not included in ASIA exam)<br> • Walking Index of Spinal Cord Injury (WISCI)<br> • Neopraxis gait assessment<br> • Ashworth Spasticity scale<br> • ASIA sensory examination<br> • SCIM<br> • Patient Reported Outcome (PRO)<br> ;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.;<br> Primary end point(s): Response rate using change from Baseline of = 6 points in total motor score of ASIA<br> manual motor test at Week 24.<br>
- Secondary Outcome Measures
Name Time Method