HP184 in Chronic Spinal Cord Injury Subjects

A Phase II, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of HP184 Administered Orally Once Daily for Twenty-Four Weeks in Adult Subjects With Chronic Spinal Cord Injury (CSCI)

The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Drug: HP184

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Macquarie Park, New South Wales, Australia
    • sanofi-aventis administrative Australia & New-Zealand administrative office
• Germany
  • Berlin, Germany
    • Sanofi-Aventis Administrative Office
• India
  • Mumbai, India
    • Sanofi-Aventis Administrative Office
• United Kingdom
  • Guildford Surrey, United Kingdom
    • Sanofi-Aventis Administrative Office
• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.

Secondary Outcome Measures

Outcome Measure
Safety evaluation.

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: October 5, 2004
• First Submitted That Met QC Criteria: October 6, 2004
• First Posted (Estimate): October 7, 2004

Study Record Updates

• Last Update Posted (Estimate): August 21, 2008
• Last Update Submitted That Met QC Criteria: August 20, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: DRI6213; HP184B/2002