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)

Aventis Pharmaceuticals Inc.0 个研究点目标入组 240 人开始时间: 2005年9月6日最近更新: 2012年8月14日

适应症

试验速览

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•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
•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
•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

发起方