RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover

• Register: EUCTR
• Last refreshed on: 16 October 2012
• Main ID: EUCTR2006-006752-35-FI
• Date of registration: 21/03/2007
• Prospective Registration: Yes
• Primary sponsor: Schwarz Biosciences GmbH
• Public title: RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover
• Scientific title: RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover
• Date of first enrolment: 09/05/2007
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006752-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Finland, Germany, Hungary, Italy, Spain, United Kingdom

Key inclusion & exclusion 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 willing and able to comply with all trial requirements.
3. Subject is male or female, =18 years of age.
4. Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV, see

Section 15.9) as defined by the cardinal sign, bradykinesia, and at least 1 of the
following: resting tremor, rigidity, or impairment of postural reflexes.
5. Subject has unsatisfactory early morning motor impairment as determined by the
investigator.
6. If subject is taking levodopa (L-DOPA), he/she must be on a stable dose of
L-DOPA (in combination with benserazide or carbidopa) for at least 28 days prior
to the Baseline Visit.
7. If the subject is receiving an anticholinergic agent (eg, benztropine,
trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase B
(MAO-B) inhibitor (eg, selegiline), or an n methyl-d-aspartate (NMDA) antagonist
(eg, amantadine), he/she must have been on a stable dose for at least 28 days
prior to the Baseline Visit and must be maintained on that dose for the duration
of the trial.
8. Subject must understand the investigational nature of the trial and be willing and
able to comply with the trial requirements.

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:
1. Subject has previously participated in a trial with rotigotine or has experienced
treatment failure with commercially available rotigotine (Neupro®).
2. Subject has participated in another trial of an investigational drug within the last
28 days or is currently participating in another trial of an investigational drug.
3. Subject discontinued from previous therapy with a dopamine agonist after an
adequate length of treatment, at an adequate dose, due to lack of efficacy as
assessed by the investigator.
4. Subject has had prior therapy with a dopamine agonist within 28 days prior to
Baseline (Visit 2).
5. Subject has had therapy with controlled-release L-DOPA within 28 days prior to
Baseline (Visit 2) or is receiving therapy with tolcapone.
6. Subject is receiving therapy with one of the following drugs either concurrently
or within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide,
reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine,
ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A)
inhibitors, methylphenidate, or amphetamine.
7. Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension
in the 6 months prior to Baseline.
8. Subject has atypical Parkinsonian syndromes (including drug-induced
Parkinsonian syndromes).
9. Subject has a history of atopic eczema and/or active skin disease, such as atopic
eczema.
10. Presence of dementia, active psychosis, or hallucinations (not due to
antiparkinsonian medication).
11. Subject is receiving central nervous system (CNS) therapy (eg, sedatives,
hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, other
sleep-modifying medication) unless dose has been stable daily for at least 28
days prior to Baseline (Visit 2) and is likely to remain stable for the duration of
the trial.
12. Subject has a history of seizures or stroke within 1 year, or a history of
myocardial infarction within the last 6 months prior to enrollment.
13. Subject has neoplastic disease requiring therapy within 12 months prior to
enrollment.
14. Presence of clinically relevant hepatic dysfunction.
15. Presence of clinically relevant renal dysfunction.
16. Evidence of clinically relevant cardiovascular disorders.
17. Subject has a QT interval corrected for heart rate Bazett (QTcB) of =500msec at
Screening or Baseline (Visit 1 or 2, see Section 7.3.3).
18. Subject has a history of chronic alcohol or drug abuse within the last 6 months.
19. Subject has clinically significant laboratory results that, in the opinion of the
investigator, would make the subject unsuitable for entry into the trial.
20. Subject is pregnant or nursing, or is of child bearing potential but (i) not
surgically sterile, or, (ii) not using adequate birth control methods (including a
highly effective method of birth control and at least 1 barrier method) or, (iii) not
sexually abstinent, or (iv) subject is not at least 2 years post menopausal.
21. Subject has any medical or psychiatric condition that, in the opinion of the
investigator, can jeopardize or would compromise the subject’s ability to
participate in this trial.
22. Subject has evidence of an impulse control disorder according to the Jay Modified
Minnesota Impulsive Disorders Int

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Parkinson's disease
MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease

Intervention(s)

Trade Name: Neupro 2mg/24 h transdermal patch

Product Code: ND1587
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4.5-mg
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Trade Name: Neupro 4mg/24 h transdermal patch

Product Code: ND1589
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9.0-mg
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Trade Name: Neupro 6mg/24 h transdermal patch

Product Code: ND1590
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 13.5-mg
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Trade Name: Neupro 8 mg/24 h transdermal patch

Product Code: ND1702
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: 99755-59-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18.0-mg
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Primary Outcome(s)

Primary end point(s): • Change from Baseline to the end of Maintenance in early morning UPDRS Part III
score (early morning, prior to any medication intake)
• Change from Baseline to end of Maintenance in Parkinson’s Disease Sleep Scale
(PDSS)

Secondary Objective: In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson’s disease will be evaluated.

Main Objective: The objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinson’s disease.

Secondary ID(s)

SP889