Skip to main content
OpenTrials
Completed

NCT Number: NCT00936676

ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects

Eligible participants, who participated in the ADAGIO trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations. participants who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical benefit from restarting treatment can also be considered for enrollment in the Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed necessary by the treating physician (according to the participants clinical status).

Completed

Looking for future studies?

Notify Me

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Teva Investigational Site 7160, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who participated in the ADAGIO study, and who entered the active phase of the study and
  • Subjects who are currently on rasagiline treatment (or subjects who have stopped rasagiline treatment, are willing to restart treatment, and in the opinion of the investigator will gain clinical benefit from restarting treatment) and
  • Subjects with a diagnosis of Parkinson's disease and
  • Subjects willing and able to give written informed consent

Exclusion criteria

  • Subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently.
  • Subjects who cannot be given rasagiline due to any exclusion based on the local label (including pregnancy or nursing women) or due to the use of medications contraindicated for concomitant use with rasagiline according to local label
  • Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation

Treatment and study plan

rasagiline mesylate

Drug

During the Core follow-up study period, subjects will continue to receive 1 mg rasagiline once a day. During the Extended follow-up study period, only subjects who are still on rasagiline at Visit 9 will continue to receive treatment with rasagiline 1 mg per day. Tablets will be supplied by the Sponsor and given according to the label.

Other names: Azilect

Primary outcomes

  1. PD Functional Status Questionnaire

    Time frame: 36 months

    Assess Benefits of rasagiline treatment using yes/no questions; Milestones of time to treatment-Dopaminergic treatment, levodopa, surgery for PD, time to -dyskinesia, hallucinations, functional decline using an aggregate of the responses to PD Functional Status Questionnaire

  2. UPDRS scores

    Time frame: 36 months

    Part I is designed to rate mentation, behavior and mood (questions 1-4). Part II (questions 5-17) is designed to rate activities of daily life. Both parts I and II are to be collected as historical information. Part III (questions 18-31) is done as a motor examination at the time of a visit as defined in this protocol. The various items to be rated are scored using a 5-point system (i.e., 0 is normal and 4 indicates a severe abnormality, half point scores are allowed for Part III questions).

  3. EDL scale

    Time frame: 36 months

  4. Hoehn and Yahr scale

    Time frame: 36 months

    0 indicates asymptomatic to 5 which indicates wheelchair bound

  5. Parkinson's Fatigue Scale

    Time frame: 36 months

    1 indicates strongly disagree to 5 which indicates strongly agree

  6. Montreal Cognitive Assessment (MoCA) Scale

    Time frame: 36 months

    assessment of mild cognitive deficits

  7. Non-motor symptom questionnaire of the PD Society

    Time frame: 36 months

    Yes/No questions

  8. Quality of Life Questionnaire

    Time frame: 36 months

    Qualitative questions using Never to Always answers

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Collaborators

  • H. Lundbeck A/S
  • Teva Neuroscience, Inc.

Registry information

Official study title

An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects Who Participated in the ADAGIO Study

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2009
Registry last updated
Apr 11, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.