Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479154
Status:
COMPLETED
Last Update Posted:
2012-04-26
First Post:
2007-05-25
Brief Title:
Botulinum Toxin to Treat Restless Legs Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Botulinum Toxin Type A for the Treatment of Restless Legs Syndrome
Status:
COMPLETED
Status Verified Date:
2012-04
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 will test whether botulinum toxin Botox may relieve the uncomfortable sensations patients with restless legs syndrome RLS experience RLS is a common movement disorder that causes sensory discomfort and restlessness most often in the legs which improves with movement Although medications are available to treat the disorder many people experience side effects that prevent them from continuing on the medication The Food and Drug Administration has approved Botox for other movement disorders and for some cosmetic uses
People 18 years of age or older with moderate to severe RLS who have been taking RLS medications for more than 6 weeks before entering the study may be eligible to participate Candidates are screened with a medical history physical and neurological examinations blood tests and for women who can become pregnant a urine pregnancy test
Participants are randomly assigned to receive injections of either Botox or placebo salt water into up to nine areas of the legs The correct location of the muscles to be injected is determined by electromyography EMG a test that measures the electrical activity of muscles For surface EMG electrodes small metal disks are filled with a conductive gel and taped to the skin Needle EMG involves inserting a needle into a muscle Both methods are used in this study
At 2 and 4 weeks after the injections subjects are interviewed by telephone and asked to describe their symptoms side effects and any improvement they may have noticed After 12 weeks they return to NIH for injections with the alternate compound that is those who received Botox previously are given placebo for the second set of injections and vice-versa Subjects are again contacted by telephone 2 and 4 weeks after the injections to report their symptoms side effects and benefits
People 18 years of age or older with moderate to severe RLS who have been taking RLS medications for more than 6 weeks before entering the study may be eligible to participate Candidates are screened with a medical history physical and neurological examinations blood tests and for women who can become pregnant a urine pregnancy test
Participants are randomly assigned to receive injections of either Botox or placebo salt water into up to nine areas of the legs The correct location of the muscles to be injected is determined by electromyography EMG a test that measures the electrical activity of muscles For surface EMG electrodes small metal disks are filled with a conductive gel and taped to the skin Needle EMG involves inserting a needle into a muscle Both methods are used in this study
At 2 and 4 weeks after the injections subjects are interviewed by telephone and asked to describe their symptoms side effects and any improvement they may have noticed After 12 weeks they return to NIH for injections with the alternate compound that is those who received Botox previously are given placebo for the second set of injections and vice-versa Subjects are again contacted by telephone 2 and 4 weeks after the injections to report their symptoms side effects and benefits
Detailed Description:
OBJECTIVE
To evaluate the efficacy of botulinum toxin type A BoNT for the treatment of primary Restless legs syndrome RLS We hypothesize that BoNT will be effective at decreasing the deep sensory discomfort of RLS
STUDY POPULATION
This protocol is a proof of principle double-blind randomized placebo-BoNT crossover outpatient pilot study of 6 patients diagnosed with moderate to very severe primary RLS
DESIGN
All subjects will be evaluated at the NIH Clinical Center by a study investigator to determine eligibility for participation in this protocol We will obtain a complete medical history and perform a neurological examination along with laboratory screening studies Subjects eligible to participate will receive baseline ratings using the Restless Legs Rating Scale RLS-RS Subjects will then be randomized to receive electromyography EMG-guided injections of up to 90 units of BoNT or an equivalent volume of saline in each lower extremity in symptomatic muscles Subjects will then receive follow up ratings at week 2 and 4 following each injection Twelve weeks after receiving the first injection subjects will crossover to receive the alternative compound with similar follow up ratings
OUTCOME MEASURES
The primary outcome measure will be mean change from baseline at 4 weeks post-injection on the RLS-RS for placebo and BoNT while the other pre specified outcomes will evaluate patient reported Clinical Global Impression of Change CGI-C scores for each group duration of effect and adverse events Only descriptive statistics will be performed on this limited data sample
To evaluate the efficacy of botulinum toxin type A BoNT for the treatment of primary Restless legs syndrome RLS We hypothesize that BoNT will be effective at decreasing the deep sensory discomfort of RLS
STUDY POPULATION
This protocol is a proof of principle double-blind randomized placebo-BoNT crossover outpatient pilot study of 6 patients diagnosed with moderate to very severe primary RLS
DESIGN
All subjects will be evaluated at the NIH Clinical Center by a study investigator to determine eligibility for participation in this protocol We will obtain a complete medical history and perform a neurological examination along with laboratory screening studies Subjects eligible to participate will receive baseline ratings using the Restless Legs Rating Scale RLS-RS Subjects will then be randomized to receive electromyography EMG-guided injections of up to 90 units of BoNT or an equivalent volume of saline in each lower extremity in symptomatic muscles Subjects will then receive follow up ratings at week 2 and 4 following each injection Twelve weeks after receiving the first injection subjects will crossover to receive the alternative compound with similar follow up ratings
OUTCOME MEASURES
The primary outcome measure will be mean change from baseline at 4 weeks post-injection on the RLS-RS for placebo and BoNT while the other pre specified outcomes will evaluate patient reported Clinical Global Impression of Change CGI-C scores for each group duration of effect and adverse events Only descriptive statistics will be performed on this limited data sample
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 |
|---|---|---|---|
| 07-N-0160 | OTHER | Intramural NINDS Protocol 07-N-0160 | None |