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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Secondary ID [2] 0 0
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
Skin 0 0 0 0
Other skin conditions
Injuries and Accidents 0 0 0 0
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - HP184

Treatment: Drugs: HP184

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Any clinical evidence of recent fracture(s) within the last six months prior to study

- Any history of Multiple Sclerosis or peripheral demyelinating disease or neuromuscular

- 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

- 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

- 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
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
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
State/province [2] 0 0
Country [3] 0 0
State/province [3] 0 0
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Guildford Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
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
Other publications