Trial Review

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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00093275