Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260741
Status:
TERMINATED
Last Update Posted:
2007-04-04
First Post:
2005-11-30
Brief Title:
Cannabis for Spasticity in Multiple Sclerosis
Sponsor:
Center for Medicinal Cannabis Research
Organization:
Center for Medicinal Cannabis Research
Study Overview
Official Title:
Cannabis for Spasticity in Multiple Sclerosis A Placebo-Controlled Study
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Discontinued due to non-enrollment
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn if the use of inhaled cannabis marijuana and oral cannabinoid dronabinol Marinol or THC which is an active ingredient of marijuana is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis
Detailed Description:
The treatment of MS is far from satisfactory For acute attacks high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks Immunomodulatory agents available in this disease over the last decade reduce the frequency of severe attacks by about one third The remainder of the treatments are symptomatic aimed at reducing the disability already present
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS In light of the autoimmune hypothesis of the etiology of MS THC could directly alter immune function in a manner that might reduce or increase the primary pathology of the disease
Comparisons Three treatment arms will be compared 1 inhaled cannabis and oral placebo 2 inhaled placebo and oral THC 3 inhaled placebo and oral placebo with the effects of these agents analyzed at thirty and sixty days
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS In light of the autoimmune hypothesis of the etiology of MS THC could directly alter immune function in a manner that might reduce or increase the primary pathology of the disease
Comparisons Three treatment arms will be compared 1 inhaled cannabis and oral placebo 2 inhaled placebo and oral THC 3 inhaled placebo and oral placebo with the effects of these agents analyzed at thirty and sixty days
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 |
|---|---|---|---|
| 200311404-4 | None | None | None |