Trial Outcomes & Findings for Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome. (NCT NCT01931878)

Results Overview

The Restless Legs Syndrome Rating Scale uses 10 questions, each scored 0-4, with higher scores representing more severe symptoms. Score ranges from 1-40. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

6 weeks

Results posted on

2016-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo First, Then Incobotulinumtoxin A Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug.	IncobotulinumtoxinA First, Then Placebo The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin) incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo.
First Intervention STARTED	10	14
First Intervention COMPLETED	9	14
First Intervention NOT COMPLETED	1	0
Second Intervention (After 3 Months) STARTED	9	14
Second Intervention (After 3 Months) COMPLETED	9	12
Second Intervention (After 3 Months) NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=21 Participants The subject may be randomly assigned to receive Placebo, saline Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	60.71 years STANDARD_DEVIATION 12.36 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Total RLS scale score was compared between incoA injections and and saline group injections.

The Restless Legs Syndrome Rating Scale uses 10 questions, each scored 0-4, with higher scores representing more severe symptoms. Score ranges from 1-40. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40)

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections.	Xeomin n=21 Participants incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
Mean Total Restless Leg Syndrome Rating Scale Score	25.19 units on a scale Standard Deviation 7.82	19.46 units on a scale Standard Deviation 9.41

SECONDARY outcome

Timeframe: 6 weeks

The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 5 or above on the PGIC 6 weeks after treatment.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections.	Xeomin n=21 Participants incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved	3 participants	9 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

The Visual Analog Scale (VAS) consists of a line which represents the level of pain in 10 cms. The subject is required to make this line to show where your pain level is on this line (for example, at the 7cm mark). A higher score is associated with a higher level of pain. Number of patients showing a pain score of \<4.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections.	Xeomin n=21 Participants incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
Patients With Pain on Visual Analog Scale <4	3 participants	12 participants

Adverse Events

Placebo , Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IncobotulinumtoxinA Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bahman Jabbari M.D.

Yale University School of Medicine

Phone: 203-737-2464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place