Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200941
Status:
COMPLETED
Last Update Posted:
2005-12-16
First Post:
2005-09-12
Brief Title:
Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome
Sponsor:
Neurocare
Organization:
Neurocare
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Study to Determine the Effacy and Safety of Topiramate in Subjects With Restless Legs Syndrome RLS
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
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 study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome
Detailed Description:
Benzodiazepines levo-dopacarbidopa dopamine agonists anticonvulsants and opioids have been used with variable success to treat RLS Often RLS patients treated with a benzodiazepine over the course of several months develop tolerance to the medication Also benzodiazepines can cause confusion or daytime sleepiness and may be addictive Patients may also develop tolerance to levo-dopacarbidopa treatment Because of the short half-life symptoms may be suppressed for only the first part of the sleep period and then recur later during the night Rebound has been reported Worse yet augmentation the occurrence of RLS symptoms often more severe than before treatment began earlier in the day may occur in up to 80 of RLS patients treated with levod-dopacarbidopa Dopamine agonists including pergolide pramipexole and ropinirole are effective for some patients but not for others Common side effects of these drugs include coryza hypotension and rash Of the anticonvulsants preliminary reports suggest that gabapentin carbamazepine and divalproex can suppress RLS symptoms in some patients especially those with mild RLS Side effects include sleepiness ataxia and weight gain Opioid treatment for RLS has been described as effective but aside from the stigma of taking controlled substances regularly side effects may include nausea sedation constipation and dysequilibrium Iron supplementation is therapeutic in some patients with iron deficiency and RLS
Preliminary anecdotal data suggest that topiramate reduces RLS symptoms Topiramate has several potential mechanisms of action including enhancement of GABA-mediated inhibition which may account for the observed benefit in patients with RLS
Topiramate may be a better alternative than the currently available treatments to suppress RLS symptoms Like gabapentin it offers the possibility of decreasing RLS symptoms while also diminishing pain especially in those patients who have limb pain from neuropathy radiculopathy or other causes Unlike gabapentin topiramate may help overweight patients with RLS lose weight if anedotal reports on weight reduction with the medication are correct
Preliminary anecdotal data suggest that topiramate reduces RLS symptoms Topiramate has several potential mechanisms of action including enhancement of GABA-mediated inhibition which may account for the observed benefit in patients with RLS
Topiramate may be a better alternative than the currently available treatments to suppress RLS symptoms Like gabapentin it offers the possibility of decreasing RLS symptoms while also diminishing pain especially in those patients who have limb pain from neuropathy radiculopathy or other causes Unlike gabapentin topiramate may help overweight patients with RLS lose weight if anedotal reports on weight reduction with the medication are correct
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