Effects of cannabinoids for controlling spasticity in persons with chronic spinal cord injury
Phase 2
- Conditions
- Chronic spinal cord injuryIntractable spasticityPainSleep dysfunctionspinal cord injuryspasticitypainsleepcannabinoids
- Registration Number
- TCTR20220329001
- Lead Sponsor
- The Government Pharmaceutical Organization of Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Persons with traumatic spinal cord injury
Age between 20-65 years
Able to communicate in Thai
Onset of injury more than 1 year
Any level and severity of injury
Having intractable systemic spasticity (MAS > 2 despite receiving maximum tolerable oral antispastic drugs)
Exclusion Criteria
Age < 20 years
Abnormal blood test
Severe Co-morbid disease
Pregnancy or breast feeding
History of psychotic disorder
First degree relative with schizophrenia
History of suicidal attempt or current suicidal idea
Currently on Carbamazepine, Phenytoin, Fluoxetine, Clobazam, Valproic acid
Currently use cannabinoids/cannabis
Positive urine cannabinoids screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spasticity at 1 month after intervention Ashworth scale
- Secondary Outcome Measures
Name Time Method eural excitability at 1 month after intervention H/M ratio