Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms (NCT NCT00389831)

Last Updated: 2014-10-02

Results Overview

Subjects rate the severity of the RLS symptoms at the start of each pre dose and post dose Suggested Immobilization Test (SIT-0 to SIT-6) and every 5min during each SIT, using a numeric symptoms severity scale, where 0=not severe and 10=very severe.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

4 hours post-treatment period at each treatment day

Results posted on

2014-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Subjects receiving a single dose of placebo nasal spray on all 4 treatment days	Rotigotine Nasal Spray Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
Overall Study STARTED	10	34
Overall Study COMPLETED	10	27
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects receiving a single dose of placebo nasal spray on all 4 treatment days	Rotigotine Nasal Spray Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
Overall Study Lack of Efficacy	0	2
Overall Study Did not receive treatment.	0	2
Overall Study Other reasons	0	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants Subjects receiving a single dose of placebo nasal spray on all 4 treatment days	Rotigotine Nasal Spray n=34 Participants Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	33 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	55.5 years STANDARD_DEVIATION 5.40 • n=5 Participants	52.9 years STANDARD_DEVIATION 7.78 • n=7 Participants	53.5 years STANDARD_DEVIATION 7.33 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	21 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Germany	10 participants n=5 Participants	34 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours post-treatment period at each treatment day

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Placebo - Day 1 n=10 Participants Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.	Placebo - Day 2 n=10 Participants Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.	Placebo - Day 3 n=10 Participants Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.	Placebo - Day 4 n=10 Participants Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.	Rotigotine Nasal Spray - Placebo n=31 Participants Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.	Rotigotine Nasal Spray - Rotigotine 62µg n=31 Participants Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.	Rotigotine Nasal Spray - Rotigotine 124µg n=28 Participants Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.	Rotigotine Nasal Spray - Rotigotine 247µg n=28 Participants Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo	2.6 score on a scale Standard Deviation 1.76	2.2 score on a scale Standard Deviation 1.44	2.5 score on a scale Standard Deviation 2.03	2.0 score on a scale Standard Deviation 1.65	2.9 score on a scale Standard Deviation 1.99	2.7 score on a scale Standard Deviation 1.84	2.0 score on a scale Standard Deviation 1.14	1.5 score on a scale Standard Deviation 1.21

PRIMARY outcome

Timeframe: 4 hours post-treatment period at each treatment day

Population: Full Analysis Set

The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements would result in a score of 0 PLM per hour. Outcome is the average movements per hour in the 4 hour post-dose period per subject.