Restless Legs SyndromePhase 2NCT00389831

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

A Phase 2 study testing Rotigotine Nasal Spray in people with Restless Legs Syndrome, run by UCB Pharma at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Restless Legs Syndrome
What is being tested?: Rotigotine Nasal Spray
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteGermany
Study dates: Aug 2006to Dec 2006
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Schwarz BioSciences GmbH
Monheim

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Trial to Assess the Efficacy, Safety and Tolerability of Ascending Doses of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms in Subjects With Idiopathic Restless Legs Syndrome

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).

Conditions: Restless Legs Syndrome
Being tested: Rotigotine Nasal Spray, Placebo Nasal Spray
Keywords: Rotigotine, Rotigotine nasal spray, Efficacy, safety and tolerability, Restless Legs Syndrome
Medical subject headings: Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rotigotine Nasal SprayDrug
Also called SPM937
Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution
Placebo Nasal SprayOther
Daily single dose of placebo delivered as single puff of nasal spray solution

Study groups in NCT00389831
Study group	Role	What they receive
Placebo	Placebo comparator	Subjects receiving a single dose of placebo nasal spray on all 4 treatment days Receives: Other: Placebo Nasal Spray
Rotigotine Nasal Spray	Experimental	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 Receives: Drug: Rotigotine Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 hours post-treatment period at each treatment day
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.
Measured: 4 hours post-treatment period at each treatment day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Dec 2006

First posted19 Oct 2006 (estimated)
Study startAug 2006
Primary completionNov 2006
Study completionDec 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00389831
Sponsor's protocol ID: SP0879
Other IDs: 2006-001937-17
Status last verified: Feb 2011
First submitted: 17 Oct 2006
Last updated: 2 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Trial to Assess the Efficacy, Safety and Tolerability of Ascending Doses of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms in Subjects With Idiopathic Restless Legs Syndrome
ClinicalTrials.gov ID: NCT00389831
Acronym / sponsor ID: SP0879
Conditions: Restless Legs Syndrome
Keywords: Rotigotine, Rotigotine nasal spray, Efficacy, safety and tolerability, Restless Legs Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Nov 2006 (actual)
Study completion: Dec 2006 (actual)
First posted: 19 Oct 2006 (estimated)
Results: Posted 4 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo Nasal SpraySubjects receiving a single dose of placebo nasal spray on all 4 treatment days
Rotigotine Nasal Spray	Experimental	Drug: Rotigotine Nasal SpraySubjects 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rotigotine Nasal SprayAlso: SPM937Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution	Drug	Rotigotine Nasal Spray
Placebo Nasal SprayDaily single dose of placebo delivered as single puff of nasal spray solution	Other	Placebo

Primary outcome

Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo
Time frame: 4 hours post-treatment period at each treatment day
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.
Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.
Time frame: 4 hours post-treatment period at each treatment day
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.

Results and safety

Results posted to the registry on 4 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	10	10
Rotigotine Nasal Spray	34	27

Primary outcome: Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo

Time frame: 4 hours post-treatment period at each treatment day. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo - Day 1 n = 10	Placebo - Day 2 n = 10	Placebo - Day 3 n = 10	Placebo - Day 4 n = 10	Rotigotine Nasal Spray - Placebo n = 31	Rotigotine Nasal Spray - Rotigotine 62µg n = 31	Rotigotine Nasal Spray - Rotigotine 124µg n = 28	Rotigotine Nasal Spray - Rotigotine 247µg n = 28
Value	2.6 (1.76)	2.2 (1.44)	2.5 (2.03)	2.0 (1.65)	2.9 (1.99)	2.7 (1.84)	2.0 (1.14)	1.5 (1.21)

Population analysed: Full Analysis Set

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

Time frame: 4 hours post-treatment period at each treatment day. Mean (Standard Deviation). Unit: PLM per hour

Measure	Placebo - Day 1 n = 10	Placebo - Day 2 n = 10	Placebo - Day 3 n = 10	Placebo - Day 4 n = 10	Rotigotine Nasal Spray - Placebo n = 31	Rotigotine Nasal Spray - Rotigotine 62µg n = 31	Rotigotine Nasal Spray - Rotigotine 124µg n = 27	Rotigotine Nasal Spray - Rotigotine 247µg n = 28
Value	37.8 (35.10)	22.6 (28.36)	34.9 (39.78)	19.0 (23.60)	28.7 (29.91)	25.4 (25.14)	26.2 (22.78)	20.2 (21.70)

Population analysed: Full Analysis Set

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Day 1	0 of 10 (0%)	4 of 10 (40%)	Not reported
Placebo - Day 2	0 of 10 (0%)	3 of 10 (30%)	Not reported
Placebo - Day 3	0 of 10 (0%)	2 of 10 (20%)	Not reported
Placebo - Day 4	0 of 10 (0%)	2 of 10 (20%)	Not reported
Rotigotine Nasal Spray - Placebo	0 of 31 (0%)	16 of 31 (51.6%)	Not reported
Rotigotine Nasal Spray - Rotigotine 62µg	0 of 31 (0%)	14 of 31 (45.2%)	Not reported
Rotigotine Nasal Spray - Rotigotine 124µg	0 of 28 (0%)	10 of 28 (35.7%)	Not reported
Rotigotine Nasal Spray - Rotigotine 247µg	0 of 28 (0%)	11 of 28 (39.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marianne Raetz study director

Schwarz BioSciences GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rotigotine Nasal Spray in people with Restless Legs Syndrome, run by UCB Pharma at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo (time frame: 4 hours post-treatment period at each treatment day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.