Azilect® In Wearing-Off (AIWO)

Sponsor

Teva Pharma GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT02384512

Collaborator

Anfomed GmbH (Industry)

261

Enrollment

140

Locations

Duration (Months)

1.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

End-of-dose fluctuations e. g. wearing-off are defined as a recurrence of motor and non-motor Parkinson's Disease (PD) symptoms that precedes a scheduled dose and improves with the next dose of anti-parkinsonian medication. Azilect® is approved and recommended for therapy of wearing-off-/End-of-dose fluctuations and improves motor fluctuations significantly in combination therapy with L-dopa and other parkinsonian medication.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Azilect®

Detailed Description

The aim of the non-interventional study is to document efficacy and tolerability of rasagiline as a combination therapy in patients with wearing-off-/End-of-dose fluctuations and the effect of rasagiline on individual wearing-off symptoms, recognized by wearing-off questionnaire 32 (WOQ-32).

Study Design

Study Type:

Observational

Actual Enrollment :

261 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Azilect® In Wearing-Off (AIWO) Non-interventional Study on Efficacy and Tolerability of Rasagiline (1mg/d) add-on in Ambulatory Parkinson's Disease Patients With Wearing-off Symptoms Diagnosed by Wearing-off Questionnaire (WOQ-32)

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Jan 1, 2015

Outcome Measures

Primary Outcome Measures

Wearing-off Questionnaire-32 (WOQ-32) [12 weeks]
Alterations of 32 different wearing-off symptoms (Patient questionnaire)

Secondary Outcome Measures

WHO-5 [12 weeks]
Alterations of patient's Quality of life (patient questionnaire)
GI-I [12 weeks]
Self-Assessment of global improvement (patient questionnaire)
Columbia University Rating Scale (CURS) [12 weeks]
Alteration of PD symptoms (physician rated questionnaires)
Clinical global impression improvement (CGI-I) [12 weeks]
(physician rated questionnaires)
Percentage of participants with adverse events [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion:

idiopathic Parkinson's disease based on the UK Brain Bank criteria,
Wearing-off / end-of-dose akinesia
at least 18 years old,
written consent to participate in the study.

Exclusion:

contraindications according to the SmPC of Azilect®,
treatment with Azilect® in the past 3 months and / or
suffering from a relevant cognitive impairment and therefore neither understand the patient information, nor can give their consent to participate.

Contacts and Locations

Locations

	Site	City	Country
1	Teva Investigational Sites	Aalen	Germany
2	Teva Investigational Sites	Achim	Germany
3	Teva Investigational Sites	Altenburg	Germany
4	Teva Investigational Sites	Altenholz	Germany
5	Teva Investigational Sites	Alzenau	Germany
6	Teva Investigational Sites	Apolda	Germany
7	Teva Investigational Sites	Aschaffenburg	Germany
8	Teva Investigational Sites	Bad Honnef	Germany
9	Teva Investigational Sites	Bad Kissingen	Germany
10	Teva Investigational Sites	Bad Mergentheim	Germany
11	Teva Investigational Sites	Bad Schwartau	Germany
12	Teva Investigational Sites	Bad Waldsee	Germany
13	Teva Investigational Sites	Bad Wörishofen	Germany
14	Teva Investigational Sites	Bensheim	Germany
15	Teva Investigational Sites	Bergisch Gladbach	Germany
16	Teva Investigational Sites	Berlin	Germany
17	Teva Investigational Sites	Bernburg	Germany
18	Teva Investigational Sites	Bielefeld	Germany
19	Teva Investigational Sites	Bochum	Germany
20	Teva Investigational Sites	Bockhorn	Germany
21	Teva Investigational Sites	Bogen	Germany
22	Teva Investigational Sites	Bonn	Germany
23	Teva Investigational Sites	Butzbach	Germany
24	Teva Investigational Sites	Buxtehude	Germany
25	Teva Investigational Sites	Chemnitz	Germany
26	Teva Investigational Sites	Cloppenburg	Germany
27	Teva Investigational Sites	Cottbus	Germany
28	Teva Investigational Sites	Dessau	Germany
29	Teva Investigational Sites	Dillingen	Germany
30	Teva Investigational Sites	Düsseldorf	Germany
31	Teva Investigational Sites	Eisleben	Germany
32	Teva Investigational Sites	Erbach	Germany
33	Teva Investigational Sites	Erfurt	Germany
34	Teva Investigational Sites	Essen	Germany
35	Teva Investigational Sites	Flensburg	Germany
36	Teva Investigational Sites	Frankfurt	Germany
37	Teva Investigational Sites	Fürth	Germany
38	Teva Investigational Sites	Gadebusch	Germany
39	Teva Investigational Sites	Gelsenkirchen	Germany
40	Teva Investigational Sites	Gera	Germany
41	Teva Investigational Sites	Gladenbach	Germany
42	Teva Investigational Sites	Greifswald	Germany
43	Teva Investigational Sites	Großbeeren	Germany
44	Teva Investigational Sites	Grünstadt	Germany
45	Teva Investigational Sites	Göppingen	Germany
46	Teva Investigational Sites	Göttingen	Germany
47	Teva Investigational Sites	Hagen	Germany
48	Teva Investigational Sites	Halsbrücke	Germany
49	Teva Investigational Sites	Hamburg	Germany
50	Teva Investigational Sites	Hannover	Germany
51	Teva Investigational Sites	Heidenheim	Germany
52	Teva Investigational Sites	Herne	Germany
53	Teva Investigational Sites	Hettstedt	Germany
54	Teva Investigational Sites	Hildesheim	Germany
55	Teva Investigational Sites	Hoppegarten	Germany
56	Teva Investigational Sites	Ilmenau	Germany
57	Teva Investigational Sites	Immenstadt	Germany
58	Teva Investigational Sites	Iserlohn	Germany
59	Teva Investigational Sites	Itzehoe	Germany
60	Teva Investigational Sites	Jülich	Germany
61	Teva Investigational Sites	Kaiserslautern	Germany
62	Teva Investigational Sites	Karlstadt	Germany
63	Teva Investigational Sites	Kastellaun	Germany
64	Teva Investigational Sites	Katzenelnbogen	Germany
65	Teva Investigational Sites	Kaufbeuren	Germany
66	Teva Investigational Sites	Kempten	Germany
67	Teva Investigational Sites	Kiel	Germany
68	Teva Investigational Sites	Kleve	Germany
69	Teva Investigational Sites	Krefeld	Germany
70	Teva Investigational Sites	Köln	Germany
71	Teva Investigational Sites	Königsbrück	Germany
72	Teva Investigational Sites	Ladenburg	Germany
73	Teva Investigational Sites	Landshut	Germany
74	Teva Investigational Sites	Lappersdorg	Germany
75	Teva Investigational Sites	Lauf	Germany
76	Teva Investigational Sites	Leer	Germany
77	Teva Investigational Sites	Leipzig	Germany
78	Teva Investigational Sites	Leverkusen	Germany
79	Teva Investigational Sites	Limburg	Germany
80	Teva Investigational Sites	Lingen	Germany
81	Teva Investigational Sites	Lohr	Germany
82	Teva Investigational Sites	Ludwigshafen	Germany
83	Teva Investigational Sites	Magdeburg	Germany
84	Teva Investigational Sites	Mainz	Germany
85	Teva Investigational Sites	Mannheim	Germany
86	Teva Investigational Sites	Markkleeberg	Germany
87	Teva Investigational Sites	Menden	Germany
88	Teva Investigational Sites	Mittweida	Germany
89	Teva Investigational Sites	Mönchengladbach	Germany
90	Teva Investigational Sites	Mühlhausen	Germany
91	Teva Investigational Sites	München	Germany
92	Teva Investigational Sites	Naumburg	Germany
93	Teva Investigational Sites	Neu-Ulm	Germany
94	Teva Investigational Sites	Neuburg	Germany
95	Teva Investigational Sites	Neunkirchen	Germany
96	Teva Investigational Sites	Neupotz	Germany
97	Teva Investigational Sites	Neusäß	Germany
98	Teva Investigational Sites	Nürnberg	Germany
99	Teva Investigational Sites	Oberhausen	Germany
100	Teva Investigational Sites	Oldenburg	Germany
101	Teva Investigational Sites	Osnabrück	Germany
102	Teva Investigational Sites	Ostfildern	Germany
103	Teva Investigational Sites	Pulheim	Germany
104	Teva Investigational Sites	Ravensburg	Germany
105	Teva Investigational Sites	Regensburg	Germany
106	Teva Investigational Sites	Ribnitz-Damgarten	Germany
107	Teva Investigational Sites	Rostock	Germany
108	Teva Investigational Sites	Rotenburg	Germany
109	Teva Investigational Sites	Saalouis	Germany
110	Teva Investigational Sites	Sande	Germany
111	Teva Investigational Sites	Schirgiswalkde-Kirschau	Germany
112	Teva Investigational Sites	Schleiden	Germany
113	Teva Investigational Sites	Schongau	Germany
114	Teva Investigational Sites	Schwarzenbruck	Germany
115	Teva Investigational Sites	Schweich	Germany
116	Teva Investigational Sites	Schweinfurt	Germany
117	Teva Investigational Sites	Schwerin	Germany
118	Teva Investigational Sites	Schwetzingen	Germany
119	Teva Investigational Sites	Seelow	Germany
120	Teva Investigational Sites	Siegen	Germany
121	Teva Investigational Sites	Sinsheim	Germany
122	Teva Investigational Sites	Solingen	Germany
123	Teva Investigational Sites	Sondershausen	Germany
124	Teva Investigational Sites	Sprockhövel	Germany
125	Teva Investigational Sites	Stade	Germany
126	Teva Investigational Sites	Stralsund	Germany
127	Teva Investigational Sites	Stuttgart	Germany
128	Teva Investigational Sites	Treuenbrietzen	Germany
129	Teva Investigational Sites	Troisdorg-Sieglar	Germany
130	Teva Investigational Sites	Tübingen	Germany
131	Teva Investigational Sites	Ulm	Germany
132	Teva Investigational Sites	Varel	Germany
133	Teva Investigational Sites	Vellmar	Germany
134	Teva Investigational Sites	Weißenfels	Germany
135	Teva Investigational Sites	Wismar	Germany
136	Teva Investigational Sites	Wolfach	Germany
137	Teva Investigational Sites	Wolfratshausen	Germany
138	Teva Investigational Sites	Wuppertal	Germany
139	Teva Investigational Sites	Zossen	Germany
140	Teva Investigational Sites	Zwickau	Germany