Status:
COMPLETED
Study to Assess Safety, Tolerability and MTD of a Central Pattern Generator-activating Tritherapy (SPINALON) in Patients With Chronic Spinal Cord Injury
Lead Sponsor:
Nordic Life Science Pipeline Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy candidate called SPINALON has been identified and is currently under development for its capacity to temporar...
Detailed Description
Spinal cord injury (SCI) is generally considered as an irreversible condition for which no curative treatment has yet been found. A recent study sponsored by the Christopher \& Dana Reeve Foundation r...
Eligibility Criteria
Inclusion
- Clinical diagnosis of complete or motor-complete SCI (ASIA-A, ASIA-B)
- Chronically injured (at least 3 months post-injury)
- Paraplegic (within T1-T12) or tetraplegic (within C3-C8)
- In relatively good health condition (no significant bed sore, urinary tract infection)
- 18-65 years of age
- Men and women
- Quebec Province residents only
Exclusion
- With unclear diagnosis
- Displayed a form of involuntary rhythmic leg muscle activity (restless leg syndrome, spontaneous activity in supine position, etc.) in the last 3 months prior to this study.
- Acute or subacute stage (within 1 day and 3 months post-injury)
- Non-traumatic (e.g., multiple sclerosis, syringomyelia, spinal tumor,etc.)
- Are given monoamine oxidase (MAO) inhibitors (two weeks prior and after Spinalon administration)
- Had seizures
- Had tumor(s) (malignant or non-malignant) or in situ carcinoma in the last five (5) years
- Allergic or hypersensitive to buspirone, levodopa or carbidopa
- Can not take sympathomimetic amines (e.g., epinephrine, pseudoephedrine)
- Currently suffering of heart problems, blood related diseases, endocrine disease, liver disease, lung disease, or kidney disease
- Receiving antihypertensive drugs
- Receiving tricyclic antidepressant
- Receiving dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone)
- Receiving phenytoin and papaverine
- With glaucoma
- With psychiatric or mental disorder(s)
- Had gastrointestinal ulcer(s) in the last five (5) years
- Pregnant or lactating woman (all women between 18 and 50 year-old not yet confirmed as pregnant, will be tested (urine test - TestPak Plus, Abbott Laboratories) on medical exam-day due to the teratogenic potential of levodopa/carbidopa.
- Children (younger than 18 year-old) or elderly (older than 65 year-old)
- Not resident of Quebec Province
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01484184
Start Date
July 1 2013
End Date
August 1 2015
Last Update
August 20 2015
Active Locations (1)
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1
McGill University Health Centre (Montreal General Hospital)
Montreal, Quebec, Canada, H3G 1A4