Clinical trial NCT01736891: Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations
Official title: Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson´s Disease
Keywords: Motor fluctuations
Parkinson´s Disease
Rasagiline
Lead sponsor: Chongqing Fortune Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2012-11-29
Enrollment: 268
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

Detailed description: Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.

The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic PD
* Patients receiving at least 300 mg daily doses of levodopa and not less than 8 daily doses of levodopa with the stable dose
* Patient with a Modified Hoehn and Yahr stage between 2 to 4 in the OFF state
* Patient with motor fluctuations averaging at least 2 hour daily in the OFF state
* Patients who have demonstrated the ability to keep accurate 24-hour diaries

Exclusion Criteria:

* Patients with Parkinsonian syndrome induced by medicine, metabolic disease, Encephalitis and central nervous system degenerative diseases or Disease of basal ganglia
* Patients with severe cognitive impairment judged by a Mini Mental State Examination
* Patients with a clinically significant psychiatric illness
* Patients with Hamilton Depression Rating Scale (HAMD): total score ≤10
* Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation
* Patients with a clinically significant or unstable vascular disease
* Patients with severe disabling dyskinesias Other inclusion and exclusion criteria may apply

Primary outcomes:
measure: Efficacy of rasagiline vs placebo as assessed by the change from baseline to week 14 in mean total daily OFF time measured by patients' home diaries in levodopa-treated PD patients with motor fluctuations.
timeFrame: 0, 14 weeks
Secondary outcomes:
measure: Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries.
timeFrame: 0, 6, 10, 16 weeks
measure: Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.
timeFrame: 0, 6, 14, 16 weeks
measure: Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) Ⅱ- Ⅵ Activities of Daily Living.
timeFrame: 0, 6, 14, 16 weeks
measure: Change from baseline to week 6/10/14/16 in mean total daily ON time measured by patients' home diaries.
timeFrame: 0, 6, 10, 14, 16 weeks
measure: Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.
timeFrame: 0, 6, 14, 16 weeks
measure: The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.
timeFrame: 0, 2, 6, 14, 16 weeks
measure: BP、 temperature、 breath and heart rate after 5 minutes of stasis.
timeFrame: -2, 0, 2, 6, 10, 14, 16 weeks
measure: Physical examination.
timeFrame: -2, 16 weeks
measure: Adverse Events: the occurrence of melanoma.
timeFrame: 0, 2, 6, 10, 14, 16 weeks
measure: Grade of UPDRS I
timeFrame: 0, 6, 14, 16 weeks
measure: Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.
timeFrame: 0, 6, 16 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: CN002
city: Chenzhou
country: China
facility: CN005
city: Chongqing
country: China
facility: CN007
city: Guilin
country: China
facility: CN003
city: Lanzhou
country: China
facility: CN004
city: Luzhou
country: China
facility: CN006
city: Nanjing
country: China
facility: CN008
city: Xi'an
country: China
facility: CN001
Study officials:
affiliation: The First Affiliated Hospital of the Fourth Military Medical University
name: Gang Zhao
role: PRINCIPAL_INVESTIGATOR
References: