Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202423
Status:
UNKNOWN
Last Update Posted:
2005-11-29
First Post:
2005-09-12
Brief Title:
Use of Cannabinoids in Patients With Multiple Sclerosis
Sponsor:
S Andrea Hospital
Organization:
S Andrea Hospital
Study Overview
Official Title:
fMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple Sclerosis
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 10-week randomised double blind placebo-controlled crossover trial to investigate the effect of Cannabis Based Medicine Extract Sativex on patterns of brain activation associated with movement in 20 MS patients suffering from lower limb spasticity Spasticity is a common symptom in Multiple Sclerosis MS occurring all over the course of the disease particularly in the progressive phasePhysiologically spasticity and hyperreflexia habitually seen in patients with pyramidal syndrome is due to lesions of other descending pathways such as the cortico reticulospinal pathways which participate in voluntary movementsIt is now known that an endocannabinoid system acts in humans by at least two types of cannabinoids receptors CB1 and CB2 There is evidence to support the view that the psychoactive ingredient in cannabis delta 9-tetrahydrocannabinol delta 9-THC and cannabinoids in general can reduce muscle spasticity in people with MS Aim of the study will be to evaluate the effect of Sativex on i patterns of brain activation associated with movement fMRI in MS patients suffering from spasticity ii changes in level of spasticity H-reflex iii changes in intracortical excitability and on synaptic intracortical network of the motor areas double shock TMS
Detailed Description:
Baseline assessment will be followed by randomisation and dose introduction Patients will be randomly assigned to two counterbalanced groups starting either with Sativex or with placebo as the first drug They will be dispensed sufficient study medication for two weeks together with a diary During the two-week treatment period all the patients will have to be reached the optimal individualised dosage to subjectively relief spasticityPatient will return after three weeks and they will undergo the fMRI and neurophysiological evaluationsThen patients will perform a two-week washout period and they will be requested to intake the alternative medicine After two weeks patients will perform a second fMRIneurophysiological study Two weeks later after a second washout period a last visit will be performed to conclude the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRIFS032 | None | None | None |