Parkinson's DiseaseReMePARKNCT01865877
Motor, Non-motor and Genetic Determinants of Progression in Parkinson's Disease: A Mexican Multicenter Cohort Study
An observational study of Parkinson's Disease, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 7 sites in Mexico.
Trial summary
The objective of the study is to assess the effect of motor, non-motor and genetic factors on the progression of Parkinson's disease as well as its impact on complications rates. A large sample of Mexican subjects with Parkinson's disease attending several referral centers will be included. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 550 participants
- Where
- 7 sitesMexico
- Study dates
- Aug 2012to Aug 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with idiopathic or genetic Parkinson's disease attending any of the participant sites in Mexico.
Who may be able to join
- Diagnosis of Parkinson's disease by the United Kingdom Parkinson's disease Society Brain Bank Criteria
- Any gender
- Any Hoehn and Yahr stage
- Written informed consent
Who cannot join
- Severe comorbidity that may limit proper neurological evaluation as judged by the investigator
- Subjects with atypical or secondary parkinsonism
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Mexico7 sites
Hospital Civil de Guadalajara
Guadalajara, Jalisco, 44280
Hospital Regional #1
Mérida, Yucatán, 97134
Hospital General de México
Mexico City, Mexico City, 06726
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico City, 14269
Hospital Universitario
Monterrey, Nuevo León, 64460
Hospital Universitario
San Luis Potosí City, San Luis Potosí, 23000
Hospital General de Zacatecas
Zacatecas City, Zacatecas, 11340
About this study
Official title: Motor, Non-motor and Genetic Determinants of Progression and Complications in Parkinson's Disease: A Multicenter Cohort Study in Mexican Population (ReMePArk)
The objective of the study is to assess the effect of motor, non-motor and genetic factors on the progression of Parkinson's disease as well as its impact on complications rates.
A large sample of Mexican subjects with Parkinson's disease attending several referral centers will be included.
Data collected will include disease severity and motor scales, non-motor scales as well as genotyping for monogenic forms of the disease.
Assessments will be performed every 6 months for two years.
Read the detailed description
Demographic and clinical data will be collected after obtaining a signed informed consent.
Recruitment will be competitive. Data collected includes age, gender, motor phenotype, age at onset, age at diagnosis, smoking history, family history, antiparkinsonic treatment, other treatments and a complete neurological evaluation.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Motor, Non-motor, Progression, Complications
- Medical subject headings
- Parkinson Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD Cohort | Subjects diagnosed with Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess motor scale change over time
Motor symptoms will be assessed by proper and validated motor scales; also minimal clinically important change will be determined.
Measured: Every 6 months for 2 years
Secondary outcomes (3)
To assess non-motor symptoms over time
Non-motor symptoms will be assessed using proper validated scales. Frequency and severity will be recorded.
Measured: Every 6 months for 2 years
To assess quality of life change over time.
Health-related quality of life will be assessed with proper validated clinimetric instruments.
Measured: Every 6 months for 2 years
To assess caregiver burden as disease progresses
Caregiver burden will be assessed by proper validated scales.
Measured: Every 12 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Amin Cervantes-Arriaga, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Investigators
- Amin Cervantes-Arriaga, MD,MSc, Principal investigator, Instituto Nacional de Neurología y Neurocirugía
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865877
- Sponsor's protocol ID
- INNN 35/12
- Other IDs
- 182133
- Acronym
- ReMePARK
- Status last verified
- Mar 2017
- First submitted
- 28 May 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cervantes-Arriaga A, Rodriguez-Violante M, Lopez-Ruiz M, Estrada-Bellmann I, Zuniga-Ramirez C, Otero-Cerdeira E, Camacho-Ordonez A, Gonzalez-Latapi P, Morales-Briceno H, Martinez-Ramirez D. [Profile characterization of Parkinson's disease in Mexico: ReMePARK study]. Gac Med Mex. 2013 Sep-Oct;149(5):497-501. Spanish.
PubMed 24108335Cervantes Arriaga A, Rodriguez Violante M, Camacho Ordonez A, Gonzalez Latapi P, Lopez Ruiz M, Estrada Bellmann I, Zuniga Ramirez C, Otero Cerdeira E. [Time from motor symptoms onset to diagnosis of Parkinson's disease in Mexico]. Gac Med Mex. 2014 Dec;150 Suppl 2:242-7. Spanish.
PubMed 25643785
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor, Non-motor and Genetic Determinants of Progression and Complications in Parkinson's Disease: A Multicenter Cohort Study in Mexican Population (ReMePArk)
- ClinicalTrials.gov ID
- NCT01865877
- Acronym / sponsor ID
- ReMePARK / INNN 35/12
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Motor, Non-motor, Progression, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Aug 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess the effect of motor, non-motor and genetic factors on the progression of Parkinson's disease as well as its impact on complications rates.
A large sample of Mexican subjects with Parkinson's disease attending several referral centers will be included.
Data collected will include disease severity and motor scales, non-motor scales as well as genotyping for monogenic forms of the disease.
Assessments will be performed every 6 months for two years.
Detailed description
Demographic and clinical data will be collected after obtaining a signed informed consent.
Recruitment will be competitive. Data collected includes age, gender, motor phenotype, age at onset, age at diagnosis, smoking history, family history, antiparkinsonic treatment, other treatments and a complete neurological evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD Cohort | – | –Subjects diagnosed with Parkinson's disease |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with idiopathic or genetic Parkinson's disease attending any of the participant sites in Mexico.
Key inclusion criteria (4 listed)
- Diagnosis of Parkinson's disease by the United Kingdom Parkinson's disease Society Brain Bank Criteria
- Any gender
- Any Hoehn and Yahr stage
- Written informed consent
Key exclusion criteria (2 listed)
- Severe comorbidity that may limit proper neurological evaluation as judged by the investigator
- Subjects with atypical or secondary parkinsonism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess motor scale change over time
Time frame: Every 6 months for 2 years
Motor symptoms will be assessed by proper and validated motor scales; also minimal clinically important change will be determined.
3 secondary outcomes
To assess non-motor symptoms over time
Time frame: Every 6 months for 2 years
To assess quality of life change over time.
Time frame: Every 6 months for 2 years
To assess caregiver burden as disease progresses
Time frame: Every 12 months for 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Results publication: PubMed 24108335Cervantes-Arriaga A, Rodriguez-Violante M, Lopez-Ruiz M, Estrada-Bellmann I, Zuniga-Ramirez C, Otero-Cerdeira E, Camacho-Ordonez A, Gonzalez-Latapi P, Morales-Briceno H, Martinez-Ramirez D. [Profile characterization of Parkinson's disease in Mexico: ReMePARK study]. Gac Med Mex. 2013 Sep-Oct;149(5):497-501. Spanish.
- Results publication: PubMed 25643785Cervantes Arriaga A, Rodriguez Violante M, Camacho Ordonez A, Gonzalez Latapi P, Lopez Ruiz M, Estrada Bellmann I, Zuniga Ramirez C, Otero Cerdeira E. [Time from motor symptoms onset to diagnosis of Parkinson's disease in Mexico]. Gac Med Mex. 2014 Dec;150 Suppl 2:242-7. Spanish.
- Instituto Nacional de Neurología y NeurocirugíaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amin Cervantes-Arriaga, MD,MSc principal investigator
Instituto Nacional de Neurología y Neurocirugía
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 7 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess motor scale change over time (time frame: Every 6 months for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01865877, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.