HP184 in Chronic Spinal Cord Injury Subjects

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 5, 2004
Last updated: August 20, 2008
Last verified: August 2008

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

Condition Intervention Phase
Spinal Cord Injury
Drug: HP184
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • Safety evaluation.

Enrollment: 262
Study Start Date: October 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093275

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
sanofi-aventis administrative Australia & New-Zealand administrative office
Macquarie Park, New South Wales, Australia
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Mumbai, India
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00093275     History of Changes
Other Study ID Numbers: DRI6213, HP184B/2002
Study First Received: October 5, 2004
Last Updated: August 20, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 16, 2014