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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00093275




Registration number
NCT00093275
Ethics application status
Date submitted
5/10/2004
Date registered
7/10/2004
Date last updated
21/08/2008

Titles & IDs
Public title
HP184 in Chronic Spinal Cord Injury Subjects
Scientific 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)
Secondary ID [1] 0 0
HP184B/2002
Secondary ID [2] 0 0
DRI6213
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Safety evaluation.
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
262
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
sanofi-aventis administrative Australia & New-Zealand administrative office - Macquarie Park, New South Wales
Recruitment postcode(s) [1] 0 0
- Macquarie Park, New South Wales
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
India
State/province [3] 0 0
Mumbai
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).
Trial website
https://clinicaltrials.gov/study/NCT00093275
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00093275