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HP184 in Chronic Spinal Cord Injury Subjects

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HP184
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • sanofi-aventis administrative Australia & New-Zealand administrative office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Outcomes

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.

Full Information

First Posted
October 5, 2004
Last Updated
August 20, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00093275
Brief Title
HP184 in Chronic Spinal Cord Injury Subjects
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HP184
Primary Outcome Measure Information:
Title
Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.
Secondary Outcome Measure Information:
Title
Safety evaluation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
sanofi-aventis administrative Australia & New-Zealand administrative office
City
Macquarie Park, New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Mumbai
Country
India
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom

12. IPD Sharing Statement

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HP184 in Chronic Spinal Cord Injury Subjects

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