HP184 in Chronic Spinal Cord Injury Subjects

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00093275
First received: October 5, 2004
Last updated: August 20, 2008
Last verified: August 2008
  Purpose

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)
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Australia
sanofi-aventis administrative Australia & New-Zealand administrative office
Macquarie Park, New South Wales, Australia
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
India
Sanofi-Aventis Administrative Office
Mumbai, India
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
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
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014