EFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTS

• Register: EUCTR
• Last refreshed on: 31 July 2012
• Main ID: EUCTR2012-001218-40-IT
• Date of registration: 23/07/2012
• Prospective Registration: No
• Primary sponsor: FONDAZIONE SANTA LUCIA
• Public title: EFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTS
• Scientific title: EFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTS
• Date of first enrolment: 21/05/2012
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001218-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Italy

Contacts

• Name: DIREZIONE SCIENTIFICA
• Affiliation: FONDAZIONE SANTA LUCIA

• Name: DIREZIONE SCIENTIFICA
• Affiliation: FONDAZIONE SANTA LUCIA

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patients with idiopathic PD, age range between 50 and 75;
2. Modified Hoehn and Yahr Score either =2 (and therapy only on LD – any formulation, soluble, standard, or prolonged release, i.e.).
3. PD patients willing and able to comply with scheduled visits, treatment plan and other study procedures. They should be able to recognize the off-time and on-time periods during waking hours and fulfill the different self-rated diaries.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion criteria:
1. Atypical parkinsonism syndromes due to drugs or neurodegenerative disease.
2. Dementia, a defined by Mini-Mental State Exam score <24 at Screening visit.
3. PD patients already in treatment with oral dopamine agonists in the last 3 months.
4. any significant comorbility and systemic disease that could prevent compliance or completion of the study.


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

Health Condition(s) or Problem(s) studied

Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning.
MedDRA version: 14.1 Level: PT Classification code 10056242 Term: Parkinsonian gait System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: NEUPRO*7CER 4MG/24H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotina
CAS Number: 92206-54-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 9-

Trade Name: NEUPRO*7CER 6MG/24H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotina
CAS Number: 92206-54-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 13.5-

Trade Name: NEUPRO*7CER 8MG/24H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotina
CAS Number: 92206-54-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 18-

Trade Name: NEUPRO*28CER 2MG/24H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotina
CAS Number: 92206-54-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 4.5-

Trade Name: NEUPRO*28CER 4MG/24H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotina
CAS Number: 92206-54-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 9-

Trade Name: NEUPRO*28CER 6MG/24H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotina
CAS Number: 92206-54-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 13.5-

Trade Name: NEUPRO*28CER 8MG/24H
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotina
CAS Number: 92206-54-7
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 18-

Primary Outcome(s)

Secondary Objective: Assess the significance of the response to rotigotine in terms of clinical scales by UPDRS, W/O scale, Morning Akinesia scale, GCI and time spent in OFF during the day and quality of life (PDQ39) 6 weeks after titration end.

Main Objective: Determine the efficacy of rotigotine (up to 16mg) on gait parameters as well as mean velocity and stride percentages (swing, stance, double stance) 6 weeks after titration end.

Primary end point(s): Evaluation of the efficacy of rotigotine on parkinsonian patients gait performance in the morning time through Gait-Analysis system

Timepoint(s) of evaluation of this end point: Second and fifth week

Secondary Outcome(s)

Secondary end point(s): Evaluation of the effect of rotigotine on clinical scales (UPDRS, W / O scales, scales Morning akinesia, GCI) and quality of life (PDQ39 scales and a clinical diary daily)

Timepoint(s) of evaluation of this end point: first, third, fifth and sixth week

Secondary ID(s)

SC12-02

Source(s) of Monetary Support

UCB PHARMA SPA