Study to Assess Safety, Tolerability and MTD of a Central Pattern Generator-activating Tritherapy (SPINALON) in Patients With Chronic Spinal Cord Injury
Spinal Cord Injury
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Completely paralyzed, Chronically injured, Central Pattern Generator, Locomotion, Secondary complications, Activity-based training, Treadmill training, Spinal cord injury, Paraplegia, Tetraplegia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- McGill University Health Centre (Montreal General Hospital)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
buspirone or levodopa/carbidopa
Placebo
Another 2-arm design will be tested composed of 16 subjects receiving drug A or drug B at MTD dose of the combined study drug as identified in the previous 2-arm groups.
First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of SPINALON, the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively with increasing doses, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.