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Trial Outcomes & Findings for Botulinum Toxin to Treat Restless Legs Syndrome (NCT NCT00479154)

NCT ID: NCT00479154

Last Updated: 2012-04-26

Results Overview

Primary outcome measure will be the mean change from baseline in RLS scale at week 2 following placebo/BTX injections. 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

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Week 2 and Week 4 for each intervention (vs. baseline)

Results posted on

2012-04-26

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo Then Botulinum Toxin
Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
Botulinum Toxin Then Placebo
Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
Overall Study
STARTED
3
3
Overall Study
COMPLETED
3
3
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Botulinum Toxin to Treat Restless Legs Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo Then Botulinum Toxin
n=3 Participants
Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
Botulinum Toxin Then Placebo
n=3 Participants
Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
Total
n=6 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=93 Participants
3 Participants
n=4 Participants
6 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age Continuous
53.7 years
STANDARD_DEVIATION 11.8 • n=93 Participants
61.7 years
STANDARD_DEVIATION 2.5 • n=4 Participants
57.7 years
STANDARD_DEVIATION 8.8 • n=27 Participants
Sex: Female, Male
Female
2 Participants
n=93 Participants
2 Participants
n=4 Participants
4 Participants
n=27 Participants
Sex: Female, Male
Male
1 Participants
n=93 Participants
1 Participants
n=4 Participants
2 Participants
n=27 Participants
Region of Enrollment
United States
3 participants
n=93 Participants
3 participants
n=4 Participants
6 participants
n=27 Participants

PRIMARY outcome

Timeframe: Week 2 and Week 4 for each intervention (vs. baseline)

Primary outcome measure will be the mean change from baseline in RLS scale at week 2 following placebo/BTX injections. 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=6 Participants
Injection into set of leg muscles with Placebo.
Botulinum Toxin
n=6 Participants
Injection of Botulinum Toxin (90 mU per leg).
Change in Restless Legs Syndrome Rating Scale
Week 2
-5.0 RLS Rating Score
Standard Deviation 5.1
-1.0 RLS Rating Score
Standard Deviation 3.5
Change in Restless Legs Syndrome Rating Scale
Week 4
-2.7 RLS Rating Score
Standard Deviation 5.9
-5.0 RLS Rating Score
Standard Deviation 6.0

Adverse Events

Placebo Then Botulinum Toxin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Botulinum Toxin Then Placebo

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

Fatta Nahab

NINDS/NIH

Phone: 301-496-9526

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place