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NCT Number: NCT01736891

Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor 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.

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Key information

Conditions

Parkinson´s Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CN002, Chengdu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rasagiline

Drug

Tablets, qd

Other names: Azilect

Placebo

Drug

Tablets, qd

Primary outcomes

  1. 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.

    Time frame: 0, 14 weeks

Secondary outcomes

  1. Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries.

    Time frame: 0, 6, 10, 16 weeks

  2. Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.

    Time frame: 0, 6, 14, 16 weeks

  3. Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) Ⅱ- Ⅵ Activities of Daily Living.

    Time frame: 0, 6, 14, 16 weeks

  4. Change from baseline to week 6/10/14/16 in mean total daily ON time measured by patients' home diaries.

    Time frame: 0, 6, 10, 14, 16 weeks

  5. Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.

    Time frame: 0, 6, 14, 16 weeks

  6. The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.

    Time frame: 0, 2, 6, 14, 16 weeks

  7. BP、 temperature、 breath and heart rate after 5 minutes of stasis.

    Time frame: -2, 0, 2, 6, 10, 14, 16 weeks

  8. Physical examination.

    Time frame: -2, 16 weeks

  9. Adverse Events: the occurrence of melanoma.

    Time frame: 0, 2, 6, 10, 14, 16 weeks

  10. Grade of UPDRS I

    Time frame: 0, 6, 14, 16 weeks

  11. Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.

    Time frame: 0, 6, 16 weeks

Sponsors and collaborators

Lead sponsor

Chongqing Fortune Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Beijing Bionovo Medicine Development Co., Ltd.

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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