PHASE 3B, OPEN-LABEL, MULTICENTER TRIAL TO ASSESS THE PRACTICABILITY AND TOLERABILITY OF SWITCHING SUBJECTS OVERNIGHT FROM PRAMIPEXOLE OR ROPINIROLE TO ROTIGOTINE TRANSDERMAL PATCH AND ITS EFFECT ON SYMPTOMS IN SUBJECTS WITH IDIOPATHIC RESTLESS LEGS SYNDROME
- Conditions
- Restless Legs SyndromeMedDRA version: 9.1Level: LLTClassification code 10058920Term: Restless legs syndrome
- Registration Number
- EUCTR2007-006558-24-GB
- Lead Sponsor
- Schwarz Biosciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Subject is informed and given ample time and opportunity to think about her/his
participation and has given her/his written informed consent.
2. Subject understands the investigational nature of the trial and is willing and able
to comply with the trial requirements.
3. Subject is male or female, aged = 18 years.
4. Subject meets the diagnosis of idiopathic RLS based on the 4 cardinal clinical
features according to the IRLSSG:
a An urge to move legs, usually accompanied or caused by uncomfortable and
unpleasant sensations in the legs (The urge to move can be present without
uncomfortable sensations. Arms or other body parts can also be affected.).
b The urge to move or unpleasant sensations begin or worsen during periods of
rest or inactivity 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.).
5. Subject has had an initial response to oral dopaminergic treatment for RLS and
is not satisfactorily controlled on pramipexole or ropinirole
6. Subject has been on treatment with either pramipexole (up to 0,54mg of
base/day respectively up to 0.75mg of salt/day) or ropinirole (up to 4mg/day)
for >/= 28 days prior to Baseline visit (current dose should be stable for a
minimum of 28 days and should be covered by the labeled total daily dose for
RLS).
7. The subject’s body mass index is = 18kg/m2 and = 35kg/m2.
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
1. Subject has shown symptoms of augmentation with the current dopaminergic
therapy with pramipexole or ropinirole.
2. Subject has secondary RLS (e.g., due to renal insufficiency [uremia], iron
deficiency anemia or low ferritin (Ferritin <30µg/l) or rheumatoid arthritis).
3. Subject has secondary RLS associated with previous or concomitant therapy
with dopamine D2 receptor antagonists, butyrophenones, metoclopramide,
atypical antipsychotics (eg, olanzapine), tri- and tetra-cyclic antidepressants
(e.g. mirtazipin), SNRI (e.g. venlafaxin), mianserine, lithium, or due to
withdrawal from drugs such as anticonvulsants, benzodiazepines, barbiturates,
and other hypnotics.
4. Subject has a positive result in at least one module of the Jay Modified
Minnesota Impulsive Disorders Interview (mMIDI) (a formal ICD diagnosis is not
necessary) at Screening Visit (SCR).
5. Subject has a current history of sleep disturbances like sleep apnea syndrome,
narcolepsy, sleep attacks/sudden onset of sleep, or myoclonus epilepsy either
observed during polysomnography or evidenced by subject history.
6. Subject has additional clinically relevant concomitant diseases such as
polyneuropathy, akathisia, claudication, varicosis, painful legs and moving toes,
or radiculopathy.
7. Subject has other central nervous system diseases such as dementia,
progressive supranuclear paresis, multisystem atrophy, Huntington’s chorea,
amyotrophic lateral sclerosis, or Alzheimer’s disease.
8. Subject has a prior history of psychotic episodes.
9. Subject has a history of chronic alcohol or drug abuse within the last 12 months.
10. 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.
11. Subject has clinically relevant cardiac dysfunction and/or arrhythmias (e.g.,
suspected conduction system dysregulations, second or third degree AV block,
complete left or right bundle branch block, sick-sinus-syndrome, New York Heart
Association Class III or IV congestive heart failure, or has had a myocardial
infarction within 12 months prior to Screening Visit (SCR).
12. Subject has clinically relevant venous or arterial peripheral vascular disease.
13. Subject has clinically relevant renal dysfunction (serum creatinine >2.0mg/dL).
14. Subject has clinically relevant hepatic dysfunction (total bilirubin >2.0mg/dL or
alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater
than 2 times the upper limit of the reference range).
15. Subject has a malignant neoplastic disease requiring therapy within 12 months
prior to Screening Visit (SCR).
16. Subject is currently receiving treatment with any of the following drug classes:
neuroleptics, hypnotics, anxiolytic drugs, anticonvulsive therapy, opioids,
benzodiazepines, monoamine oxidase (MAO) inhibitors, catechol-O-methyl-
transferase (COMT) inhibitors, sedative antihistamines, psychostimulates, or
amphetamines. If subject has received such therapy, a washout period of at
least 7 days prior to Baseline (BSL) is required before starting treatment in this
trial.
17. Subject is pregnant, nursing, or is a woman of child-bearing potential who is not
surgically s
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method