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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001937-17 | EudraCT Number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects receiving a single dose of placebo nasal spray on all 4 treatment days |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine Nasal Spray | Drug | Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 4 hours post-treatment period at each treatment day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Raetz | Schwarz BioSciences GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwarz BioSciences GmbH | Monheim | Germany |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects receiving a single dose of placebo nasal spray on all 4 treatment days |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects receiving a single dose of placebo nasal spray on all 4 treatment days |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set | Mean | Standard Deviation | score on a scale | 4 hours post-treatment period at each treatment day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Day 1 | Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Placebo Nasal Spray | Other | Daily single dose of placebo delivered as single puff of nasal spray solution |
|
| Other reasons |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo - Day 3 | Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3. |
| OG003 | Placebo - Day 4 | Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4. |
| OG004 | Rotigotine Nasal Spray - Placebo | Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2. |
| OG005 | Rotigotine Nasal Spray - Rotigotine 62µg | Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2. |
| OG006 | Rotigotine Nasal Spray - Rotigotine 124µg | Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3. |
| OG007 | Rotigotine Nasal Spray - Rotigotine 247µg | Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4. |
|
|
| Primary | 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. | Full Analysis Set | Mean | Standard Deviation | PLM per hour | 4 hours post-treatment period at each treatment day |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Placebo - Day 2 | Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 2. | 0 | 10 | 3 | 10 |
| EG002 | Placebo - Day 3 | Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 3. | 0 | 10 | 2 | 10 |
| EG003 | Placebo - Day 4 | Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 4. | 0 | 10 | 2 | 10 |
| EG004 | Rotigotine Nasal Spray - Placebo | Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2. | 0 | 31 | 16 | 31 |
| EG005 | Rotigotine Nasal Spray - Rotigotine 62µg | Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2. | 0 | 31 | 14 | 31 |
| EG006 | Rotigotine Nasal Spray - Rotigotine 124µg | Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3. | 0 | 28 | 10 | 28 |
| EG007 | Rotigotine Nasal Spray - Rotigotine 247µg | Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4. | 0 | 28 | 11 | 28 |
| Eye irritation | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Application site reaction | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Bacteria urine identified | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Restlessness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Sleep disorder | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |