idiopathic Restless Leg's Syndrome MedDRA version: 8.1 Level: LLT Classification code 10058920 Term: Restless legs syndrome
Conditions
Interventions
Product Name: Rotigotine Nasal Spray
Product Code: ND 1421
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Rotigotine hydrochloride
CAS Number: 125572-93-2
Concentration unit: mg/ml mi
Sponsors
Schwarz Biosciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent. 2. Subject is able to read and write German language. 3. Subject understands the investigational nature of the trial and is willing and able to comply with the trial requirements. Subject is willing to accept that he/she might be treated with pla-cebo during the treatment period. Subject is willing to be confined in the study ward for 5 days. 4. Subject is male or female, between 18 and 65 (inclusive) years of age. 5. The subject’s Body Mass Index (BMI) is between 18 and 30kg/m2 (inclusive). 6. Subject meets the diagnosis of idiopathic Restless Legs Syndrome based on the following four cardinal clinical features according to the International Restless Legs Study Group: a) An urge to move legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs.) b) The urge to move or unpleasant sensations begin or worsen during periods of rest or inac-tivity such as lying or sitting. c) The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. d) The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present.) 7. Subject has daily RLS symptoms, at least during a period of the last 4 weeks. 8. Subject is on L-dopa therapy for at least during the last 4 weeks with a maximum daily dose of 400mg. 9. Subject is a L-dopa responder (relief of symptoms under L-dopa therapy). 10. Subject scores = 11 on the RLS Diagnostic Index. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has previously participated in this trial. 2. Subject has participated in another trial of an investigational drug (or a medical device) within the last 28 days or is currently participating in another trial of an investigational drug (or a medical device). 3. Subject has secondary restless legs syndrome due to, eg, renal insufficiency (uremia), iron deficiency anemia, rheumatoid arthritis. 4. Subject has secondary restless legs syndrome associated with previous or concomitant ther-apy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical an-tipsychotics (eg, olanzapine), tri- and tetracyclic antidepressants, mianserine, lithium or H2-blockers (eg, cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodi-azepines, barbiturates, and other hypnotics. 5. Subject has a history of sleep disturbances like sleep apnea syndrome, narcolepsy, myoclonus epilepsy observed during polysomnography (PSG), polygraphy or explored in subject his-tory. 6. Subject has additional clinically relevant concomitant diseases such as polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful legs and moving toes, radicu-lopathy or cramps in the calf. 7. Subject has other central nervous diseases like Parkinson’s disease, dementia, progressive supranuclear paresis, multisystem atrophy, Huntington’s Chorea, amyotrophic lateral sclero-sis, or Alzheimer’s disease. 8. Subject has had psychotic episodes within the last 12 months which needed treatment. 9. Subject has any medical or psychiatric condition, which in the opinion of the Investigator can jeopardize or would compromise the subject’s ability to participate in this trial or confound interpretation of the data. 10. Subject has symptoms of rhinitis or local disease or irritation of the nasal mucosa at EA or on Day 1. 11. Subject has a medical history indicating intolerability to dopaminergic therapy or a known hypersensitivity to any components of the trial medication. 12. Subject has clinically relevant cardiac dysfunction and/or arrhythmias (eg, suspected conduc-tion system dysregulations, second or third degree atrioventricular (AV) block, complete left or right bundle branch block, sick-sinus- syndrome, congestive heart failure Class II, III or IV by NYHA, myocardial infarction within twelve months prior to enrollment). 13. Subject has a cardiac pacemaker. 14. Subject has a neoplastic disease requiring therapy within 60 months prior to enrollment. 15. Subject takes drugs prohibited in the course of this trial: neuroleptics, hypnotics, antidepres-sants, anxiolytic drugs, anticonvulsive therapy, psychostimulatory drugs, other dopamine agonist therapy, budipine, opioids, benzodiazepines, MAO inhibitors, COMT inhibitors, sedative antihistamines, amphetamines. 16. Subject has donated blood (=500ml) or had a comparable blood loss within the last 3 months. 17. Subject has a history of chronic alcohol or drug abuse within the last 12 months. 18. Subject has positive tests for alcohol (breath test) and/or drugs (urine test). 19. Subject is pregnant or nursing or is a woman of child-bearing potential who is not surgically sterile, postmenopausal (i.e. at least 12 month without menses), or does not consistently pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to assess the efficacy of the rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.;Secondary Objective: In addition, safety and tolerability, pharmacokinetics and the correlation between efficacy parameters and rotigotine plasma concentration will be investigated.;Primary end point(s): Efficacy • Severity of RLS symptoms in the legs (sensory symptoms): Subjects will be asked to 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 • Periodic Leg Movement during Wakefulness Index for each SIT and for specified time sec-tions of each SIT (PLMWI, PLM during awake epochs/h, motor symptoms) will be evaluated based on PLM measurements by means of actigraphy, recorded over the entire duration of the SIT period (pre dose and post dose SIT-0 to SIT-6) | — |
Countries
Germany
Outcome results
None listed