Idiopathic Parkinson DiseasePRO-GoNCT03944785

Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)

An observational study of Idiopathic Parkinson Disease, run by Supernus Pharmaceuticals, Inc. at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase IV, prospective, observational, post-marketing study designed to obtain additional data on the effect of XADAGO on motor and non-motor symptoms in Parkinson's Disease patients newly prescribed XADAGO. Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Idiopathic Parkinson Disease
What is being tested?: XADAGO (safinamide)
How many people: 164 participants
Where: 30 sitesUnited States
Study dates: 30 Nov 2017to 10 Jan 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Parkinson's Disease patients who have been newly prescribed XADAGO

Who may be able to join

Patient (and Care Partner, if required per Inclusion Criterion 6) is able to understand and provide signed informed consent and HIPAA authorization in English.
Patient with diagnosis of idiopathic PD (all stages).
Independent of the study, clinician's and patient's choice of treatment is XADAGO in accordance with the Package Insert indication.
Patient is willing and able to participate in the study and complete study-related assessments for 2 months and, patients can continue for an optional 4-month study extension.
Patient has access to an electronic device for the interim completion of PROs.
Patient has an available Care Partner who is able and willing to assist with clinic attendance and completion of study assessments (e.g., PROs, health outcomes, etc.), if in the PI's opinion, assistance is needed to comply with all study visits and procedures.

Who cannot join

Any of the warnings, precautions, or contraindications listed in the XADAGO Package Insert that in the opinion of the PI would prevent appropriate treatment with XADAGO or impair study participation (e.g., pregnancy, lactation, severe hepatic impairment, etc.).
Participation in any other clinical trial of an investigational drug or device within 4 weeks prior to the Baseline Visit or at any time during the study.
Patient is currently receiving chemotherapy or radiation for any form of cancer (if history of cancer, must be in clinical remission at study entry) or currently receiving immunotherapy.
Patients with conditions that are likely to prevent them from accurately and reliably completing study assessments, including evidence of moderate or severe dementia as determined by the clinician (not to include mild cognitive impairment [MCI]); major psychiatric illness (specifically diagnosis of schizophrenia, bipolar disorder or a history of attempted suicide); and/or severe and progressive medical illness (including terminal cancer, end-stage renal disease +/- undergoing dialysis).
Severe or unpredictable dyskinesia at the time of the Baseline Visit.
Previous participation in this study; a patient may not re-enroll after prior discontinuation or completion

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Inova Medical Group- Neurology I
Alexandria, Virginia, 22311
Movement Disorders Neurology, Inc.
Bakersfield, California, 93312
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
Southeast Neuroscience Center, LLC
Gray, Louisiana, 70359
Prisma Health
Greenville, South Carolina, 29615
FryeCare Neurology
Hickory, North Carolina, 28602
Alabama Neurology Associates
Homewood, Alabama, 35244
University of Kansas Medical Center
Kansas City, Kansas, 66160
B.E.S.T. Center of Orange County
Laguna Hills, California, 92653
Neurological Associates of Long Island, PC
Lake Success, New York, 11042
Neurology and Stroke Associates
Lititz, Pennsylvania, 17543
Valley Parkinson Clinic
Los Gatos, California, 95032
Covenant Medical Group
Lubbock, Texas, 79410
NYU Winthrop Hospital
Mineola, New York, 11501
Neuron Research
Naples, Florida, 34108
Meridian Clinical Research, LLC
Norfolk, Virginia, 23502
Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida, 33980
Baptist Health System
Richmond, Kentucky, 40475
UC Davis Medical Center
Sacramento, California, 95817
Sarasota Memorial Hospital Clinical Research Cener
Sarasota, Florida, 34239
Texas Institute for Neurological Disorders
Sherman, Texas, 75092
Lester and Cox Medical Center
Springfield, Missouri, 65807
Houston Methodist - Sugar Land
Sugar Land, Texas, 77479
Puget Sound Neurology
Tacoma, Washington, 98409
Baylor Scott and White Health
Temple, Texas, 76508
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74137
Hartford Healthcare
Vernon, Connecticut, 06066
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Central DuPage Hospital
Winfield, Illinois, 60190

Other trials in United States

About this study

Official title: A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets

Read the detailed description

This Phase IV, multicenter, prospective, observational study to evaluate clinician-reported outcomes and patient-reported outcomes related to motor and non-motor symptoms, health status, quality of life and treatment satisfaction in PD patients who have been newly prescribed XADAGO according to Package Insert indication.

This study also will gather "real world" data from a PD population in the US regarding their overall experience and degree of satisfaction with the use of XADAGO as an add-on treatment to their L-dopa regimen. Treatment experience will be captured using patient self-rating assessments as well as clinician ratings on assessments.

Conditions: Idiopathic Parkinson Disease
Being tested: XADAGO (safinamide)
Keywords: Parkinson's disease, Safinamide, Xadago, MAO-B inhibitor, off, non-motor symptoms, motor symptoms, levodopa, PD
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XADAGO (safinamide)Drug
Also called XADAGO, safinamide
XADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.

Study groups in NCT03944785
Study group	Role	What they receive
Parkinson's Disease Patients		PD patients who have been newly prescribed safinamide (XADAGO) for the treatment of OFF episodes as described in the XADAGO Package Insert Receives: Drug: XADAGO (safinamide)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score.
Measured: Baseline to Study Day 60
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores
PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes.
Measured: Baseline to Study Day 60
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score.
MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.
Measured: Baseline to Study Day 60
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.
Measured: Study Day 60
Clinical Global Impression of Change (CGI-C)
CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse).
Measured: Study Day 60
Patient Global Impression of Change (PGI-C)
PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).
Measured: Study Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 201710 Jan 2020

First posted10 May 2019
Study start30 Nov 2017
Primary completion23 Dec 2019
Study completion10 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Idiopathic Parkinson 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: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03944785
Sponsor's protocol ID: USWM-SA1-4001
Acronym: PRO-Go
Status last verified: Jul 2021
First submitted: 1 May 2019
Last updated: 7 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Idiopathic Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets
ClinicalTrials.gov ID: NCT03944785
Acronym / sponsor ID: PRO-Go / USWM-SA1-4001
Conditions: Idiopathic Parkinson Disease
Keywords: Parkinson's disease, Safinamide, Xadago, MAO-B inhibitor, off, non-motor symptoms, motor symptoms, levodopa
Study type: Observational
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 30 Nov 2017 (actual)
Primary completion: 23 Dec 2019 (actual)
Study completion: 10 Jan 2020 (actual)
First posted: 10 May 2019 (actual)
Results: Posted 18 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Parkinson's Disease Patients	–	Drug: XADAGO (safinamide)PD patients who have been newly prescribed safinamide (XADAGO) for the treatment of OFF episodes as described in the XADAGO Package Insert

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Parkinson's Disease patients who have been newly prescribed XADAGO

Key inclusion criteria (6 listed)

Patient (and Care Partner, if required per Inclusion Criterion 6) is able to understand and provide signed informed consent and HIPAA authorization in English.
Patient with diagnosis of idiopathic PD (all stages).
Independent of the study, clinician's and patient's choice of treatment is XADAGO in accordance with the Package Insert indication.
Patient is willing and able to participate in the study and complete study-related assessments for 2 months and, patients can continue for an optional 4-month study extension.
Patient has access to an electronic device for the interim completion of PROs.

Key exclusion criteria (6 listed)

Any of the warnings, precautions, or contraindications listed in the XADAGO Package Insert that in the opinion of the PI would prevent appropriate treatment with XADAGO or impair study participation (e.g., pregnancy, lactation, severe hepatic impairment, etc.).
Participation in any other clinical trial of an investigational drug or device within 4 weeks prior to the Baseline Visit or at any time during the study.
Patient is currently receiving chemotherapy or radiation for any form of cancer (if history of cancer, must be in clinical remission at study entry) or currently receiving immunotherapy.
Patients with conditions that are likely to prevent them from accurately and reliably completing study assessments, including evidence of moderate or severe dementia as determined by the clinician (not to include mild cognitive impairment [MCI]); major psychiatric illness (specifically diagnosis of schizophrenia, bipolar disorder or a history of attempted suicide); and/or severe and progressive medical illness (including terminal cancer, end-stage renal disease +/- undergoing dialysis).
Severe or unpredictable dyskinesia at the time of the Baseline Visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
XADAGO (safinamide)Also: XADAGO, safinamideXADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.	Drug	Parkinson's Disease Patients

Primary outcome

Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline to Study Day 60
MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score.
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores
Time frame: Baseline to Study Day 60
PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes.
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score.
Time frame: Baseline to Study Day 60
MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Time frame: Study Day 60
TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.
Clinical Global Impression of Change (CGI-C)
Time frame: Study Day 60
CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse).
Patient Global Impression of Change (PGI-C)
Time frame: Study Day 60
PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).

Results and safety

Results posted to the registry on 18 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DA Switchers	2	2
MAO-B Switchers	34	30
MAO-B Naive	128	123

Primary outcome: Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Time frame: Baseline to Study Day 60. Mean (Standard Deviation). Unit: score on a scale

Measure	DA Switchers n = 2	MAO-B Switchers n = 28	MAO-B Naive n = 120
Part 1	-5.0 (5.66)	-1.0 (5.13)	-1.9 (6.16)
Part 2	0.0 (2.83)	-2.3 (5.40)	-2.6 (5.28)
Part 3	1.5 (2.12)	-3.3 (7.78)	-4.5 (11.10)
Part 4	-0.5 (3.54)	-0.3 (3.28)	-0.2 (3.05)

Population analysed: Overall Number of Participants Analyzed represented by initial number analyzed at study visit Day 60; Number may differ for each Part (1-4) due to availability of score data. Evaluable Population: all subjects in the safety population who complete at least the MDS-UPDRS assessment at the Study Day 60 visit. Evaluable population will be used to analyze MDS-UPDRS endpoint.

Primary outcome: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores

Time frame: Baseline to Study Day 60. Mean (Standard Deviation). Unit: score on a scale

Measure	DA Switchers n = 1	MAO-B Switchers n = 25	MAO-B Naive n = 97
Value	-1.8	0.5 (9.73)	-0.5 (9.90)

Population analysed: Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS.

Primary outcome: Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score.

Time frame: Baseline to Study Day 60. Mean (Standard Deviation). Unit: score on a scale

Measure	DA Switchers n = 2	MAO-B Switchers n = 28	MAO-B Naive n = 119
Value	0.0 (1.41)	0.9 (2.41)	0.4 (2.45)

Primary outcome: Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores

Time frame: Study Day 60. Mean (Standard Deviation). Unit: score on a scale

Measure	DA Switchers n = 1	MAO-B Switchers n = 25	MAO-B Naive n = 99
Value	56.0	38.9 (7.73)	41.0 (9.81)

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DA Switchers	0 of 2 (0%)	1 of 2 (50%)	0 of 2
MAO-B Switchers	2 of 34 (5.9%)	8 of 34 (23.5%)	0 of 34
MAO-B Naive	8 of 128 (6.3%)	17 of 128 (13.3%)	2 of 128

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Idiopathic Parkinson Disease

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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.

Najeebah Abdul-Musawir, MD,MBA study director

Supernus Pharmaceuticals, Inc.

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Parkinson Disease, run by Supernus Pharmaceuticals, Inc. at 30 sites in United States.

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 6 inclusion and 6 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. 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?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: Baseline to Study Day 60). The study lists 6 primary outcomes in all. 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 NCT03944785.

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 7 Jun 2023.