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CompletedNCT00389831Updated Oct 2, 2014Results posted

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

A Phase 2 interventional study of Rotigotine Nasal Spray and Placebo Nasal Spray in Restless Legs Syndrome, sponsored by UCB Pharma. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-02.

Sponsored by UCB Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.

Read the detailed description

Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale.

In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness (PLMWI, PLM per hour). Subjects applied a single dose of treatment on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).

02

Conditions studied

  • Restless Legs Syndrome

Keywords

  • Rotigotine
  • Rotigotine nasal spray
  • Efficacy, safety and tolerability
  • Restless Legs Syndrome
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 44 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment

Exclusion criteria

Exclusion Criteria:

  • Patients with secondary RLS or clinically relevant concomitant diseases or medical conditions are excluded
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Subjects receiving a single dose of placebo nasal spray on all 4 treatment days

    Other: Placebo Nasal Spray

  • Experimental
    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

    Drug: Rotigotine Nasal Spray

Interventions

  • DrugRotigotine Nasal Spray

    Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution

    Also known as: SPM937

  • OtherPlacebo Nasal Spray

    Daily single dose of placebo delivered as single puff of nasal spray solution

06

What researchers measure

Primary outcomes

  1. Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo

    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.

    Time frame: 4 hours post-treatment period at each treatment day

  2. Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.

    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.

    Time frame: 4 hours post-treatment period at each treatment day

07

Results

Posted Sep 4, 2009

Participant flow

Participant flow — Overall Study
MilestonePlaceboRotigotine Nasal Spray
Started1034
Completed1027
Not completed07
Withdrew: Lack of efficacy02
Withdrew: Did not receive treatment.02
Withdrew: Other reasons02
Withdrew: Lost to follow-up01

Outcome measures

PrimaryAverage Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo

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.

Time frame:
4 hours post-treatment period at each treatment day
Reported as:
Mean · score on a scale
Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo
score on a scalePlacebo - Day 1Placebo - Day 2Placebo - Day 3Placebo - Day 4Rotigotine Nasal Spray - PlaceboRotigotine Nasal Spray - Rotigotine 62µgRotigotine Nasal Spray - Rotigotine 124µgRotigotine Nasal Spray - Rotigotine 247µg
Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo2.6 ± 1.762.2 ± 1.442.5 ± 2.032.0 ± 1.652.9 ± 1.992.7 ± 1.842.0 ± 1.141.5 ± 1.21
PrimaryAverage PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.

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.

Time frame:
4 hours post-treatment period at each treatment day
Reported as:
Mean · PLM per hour
Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.
PLM per hourPlacebo - Day 1Placebo - Day 2Placebo - Day 3Placebo - Day 4Rotigotine Nasal Spray - PlaceboRotigotine Nasal Spray - Rotigotine 62µgRotigotine Nasal Spray - Rotigotine 124µgRotigotine Nasal Spray - Rotigotine 247µg
Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.37.8 ± 35.1022.6 ± 28.3634.9 ± 39.7819.0 ± 23.6028.7 ± 29.9125.4 ± 25.1426.2 ± 22.7820.2 ± 21.70

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo - Day 1—0/10 (0%)4/10 (40%)
Placebo - Day 2—0/10 (0%)3/10 (30%)
Placebo - Day 3—0/10 (0%)2/10 (20%)
Placebo - Day 4—0/10 (0%)2/10 (20%)
Rotigotine Nasal Spray - Placebo—0/31 (0%)16/31 (51.6%)
Rotigotine Nasal Spray - Rotigotine 62µg—0/31 (0%)14/31 (45.2%)
Rotigotine Nasal Spray - Rotigotine 124µg—0/28 (0%)10/28 (35.7%)
Rotigotine Nasal Spray - Rotigotine 247µg—0/28 (0%)11/28 (39.3%)
Most frequent other events
Showing 10 of 33
Most frequent other events
EventPlacebo - Day 1Placebo - Day 2Placebo - Day 3Placebo - Day 4Rotigotine Nasal Spray - PlaceboRotigotine Nasal Spray - Rotigotine 62µgRotigotine Nasal Spray - Rotigotine 124µgRotigotine Nasal Spray - Rotigotine 247µg
HeadacheNervous system disorders3/102/100/102/109/315/313/283/28
PalpitationsCardiac disorders0/101/100/100/100/310/311/280/28
Eye irritationEye disorders0/100/101/100/100/310/311/280/28
DiarrhoeaGastrointestinal disorders1/100/100/101/102/310/310/280/28
Abdominal painGastrointestinal disorders0/100/100/101/100/310/310/280/28
FatigueGeneral disorders1/100/100/100/101/311/311/280/28
Neck painMusculoskeletal and connective tissue disorders0/101/100/100/100/310/310/280/28
ParaesthesiaNervous system disorders0/100/101/100/100/310/310/280/28
Nasal congestionRespiratory, thoracic and mediastinal disorders0/100/101/100/101/310/310/280/28
SneezingRespiratory, thoracic and mediastinal disorders0/100/101/100/100/310/310/280/28

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboRotigotine Nasal SprayTotal
<=18 years000
Between 18 and 65 years93342
>=65 years112
Age, Continuous
Age, Continuous(years)PlaceboRotigotine Nasal SprayTotal
Mean55.5 ± 5.4052.9 ± 7.7853.5 ± 7.33
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboRotigotine Nasal SprayTotal
Female82129
Male21315
Region of Enrollment
Region of Enrollment(participants)PlaceboRotigotine Nasal SprayTotal
Germany103444
08

Study locations

1 site
  • Schwarz BioSciences GmbH
    Monheim, Germany
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00389831
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Oct 19, 2006
Start date
Aug 2006
Primary completion
Nov 2006
Completion
Dec 2006
Results posted
Sep 4, 2009
Last update
Oct 2, 2014

Study contacts

Marianne Raetz
study director · Schwarz BioSciences GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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