Parkinson DiseaseTRANSCEND 1NCT05779475
An Observational Study of Patients With Moderate Parkinson's Disease
An observational study of Parkinson Disease, run by Novo Nordisk A/S at 8 sites in 4 countries.
Trial summary
The main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. Read more about this study
- Who is it for?
- Ages 50 to 68 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- No treatment given
- How many people
- 96 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 5 Apr 2023to 11 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with Parkinson's disease will be included. The participants will not receive any investigational treatment in this study.
Who may be able to join
- Male or female, aged 50-68 years (both inclusive) at the time of signing informed consent.
- Diagnosed with Parkinson's disease using the Movement Disorder Society (MDS) criteria (fulfilling the definition of clinically probable Parkinson's disease).
- Moderate Parkinson's disease, e.g. as defined by i) modified Hoehn and Yahr stage 2-3 in OFF state and ii) MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score greater than or equal to (≥) 30 in OFF state, both as judged by the investigator.
- Patient has symptoms that are not adequately controlled by existing oral anti-Parkinson's disease medications, i.e., having both ON and OFF periods, as judged by the investigator.
- Parkinson's disease duration greater than (>) 5 years and lesser than or equal to (≤) 12 years from diagnosis at the time of signing informed consent.
- Potential candidate for a future cell therapy transplantation, as judged by the investigator.
- Life expectancy >7 years as judged by the investigator.
Who cannot join
- Any atypical or secondary Parkinson's disease, or non-Parkinson's disease-suspected cause(s) of, or contributors to, parkinsonism, as judged by the investigator.
- Significant drug-induced dyskinesias as judged by the investigator, e.g., as defined by a score of > 2 in the Abnormal Involuntary Movement Scale (AIMS), in any body part in the ON state.
- Tremor-dominant Parkinson's disease, as judged by the investigator.
- Cognitive impairment predictive of dementia (including Parkinson's disease dementia) or other cognitive dysfunction as judged by the investigator, e.g., as defined by Montreal Cognitive Assessment (MoCA) score ≤ 24, or evidence of major neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria.
- Major medical or psychiatric disorder (e.g., depression (Montgomery-Asberg Depression Rating Scale (MADRS) >20) or psychosis), or other disease making the patient unsuited for participation in the study, as judged by the investigator.
- Treatment for dystonia or spasticity within 3 months of screening (Botox for a focal dystonia is allowed).
- Substantial neurological symptoms not accounted for by Parkinson's disease, including active seizure disorder, as judged by the investigator.
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
United States3 sites
Joe C.Wen & Fam CTR for Adv Care
Irvine, California, 92612
NYU Langone Health
New York, New York, 10016
NY Presbyt Hosp-W Cornell Med
New York, New York, 10021
Sweden2 sites
Neurologimottagningen Lund
Lund, 222 42
Region Skane Skanes Universitetssjukhus
Lund, 222 42
United Kingdom2 sites
Clinical Neuroscience
Cambridge, CB2 0PY
University of Cambridge - Clinical Neuroscience
Cambridge, CB2 0PY
About this study
The main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. However, the study doctor may recommend adjustments to their medication to provide a better treatment of their Parkinson's disease. Participation will last from 3 up to 24 months. During visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of Parkinson's disease using several different assessments. At a minimum of 2 visits participants will be asked to undergo 'off'-assessments.
- Conditions
- Parkinson Disease
- Being tested
- No treatment given
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Participants will not receive any investigational treatment in this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Parkinson's disease | Participants will not receive any investigational treatment in this study. The participants will be treated with anti-Parkinson's disease medication according to local standard of care. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF state
Measured as score. MDS-UPDRS consists of 4 parts - has 65 items/questions in total. Part III assesses the motor function of the patient at the time of the visit conducted in both the OFF and ON state. Each item will receive a score ranging from 0 to 4, where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
Measured: From baseline (week 0) to end of study (13 to 104 weeks from baseline)
Secondary outcomes (2)
Change in MDS-UPDRS Part III (motor score) in OFF state
Measured as score. MDS-UPDRS consists of 4 parts - has 65 items/questions in total. Part III assesses the motor function of the patient at the time of the visit conducted in both the OFF and ON state. Each item will receive a score ranging from 0 to 4, where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
Measured: From last medication adjustment (between week 0 and week 104) to end of study (13 to 104 weeks from baseline)
Is the patient interested in being considered for participation in a cell therapy transplantation study (yes/no)
Measured as count of participants
Measured: At end of study (13 to 104 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start5 Apr 2023
- Primary completion11 Mar 2030 (estimated)
- Study completion11 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779475
- Sponsor's protocol ID
- NN9001-4704
- Other IDs
- U1111-1254-1741
- Acronym
- TRANSCEND 1
- Status last verified
- Dec 2025
- First submitted
- 9 Mar 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Moderate Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05779475
- Acronym / sponsor ID
- TRANSCEND 1 / NN9001-4704
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 11 Mar 2030 (estimated)
- Study completion
- 11 Mar 2030 (estimated)
- First posted
- 22 Mar 2023 (actual)
- 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 main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. However, the study doctor may recommend adjustments to their medication to provide a better treatment of their Parkinson's disease. Participation will last from 3 up to 24 months. During visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of Parkinson's disease using several different assessments. At a minimum of 2 visits participants will be asked to undergo 'off'-assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Parkinson's disease | – | Other: No treatment givenParticipants will not receive any investigational treatment in this study. The participants will be treated with anti-Parkinson's disease medication according to local standard of care. |
Who may qualify
- Ages
- 50 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Parkinson's disease will be included. The participants will not receive any investigational treatment in this study.
Key inclusion criteria (7 listed)
- Male or female, aged 50-68 years (both inclusive) at the time of signing informed consent.
- Diagnosed with Parkinson's disease using the Movement Disorder Society (MDS) criteria (fulfilling the definition of clinically probable Parkinson's disease).
- Moderate Parkinson's disease, e.g. as defined by i) modified Hoehn and Yahr stage 2-3 in OFF state and ii) MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score greater than or equal to (≥) 30 in OFF state, both as judged by the investigator.
- Patient has symptoms that are not adequately controlled by existing oral anti-Parkinson's disease medications, i.e., having both ON and OFF periods, as judged by the investigator.
- Parkinson's disease duration greater than (>) 5 years and lesser than or equal to (≤) 12 years from diagnosis at the time of signing informed consent.
Key exclusion criteria (7 listed)
- Any atypical or secondary Parkinson's disease, or non-Parkinson's disease-suspected cause(s) of, or contributors to, parkinsonism, as judged by the investigator.
- Significant drug-induced dyskinesias as judged by the investigator, e.g., as defined by a score of > 2 in the Abnormal Involuntary Movement Scale (AIMS), in any body part in the ON state.
- Tremor-dominant Parkinson's disease, as judged by the investigator.
- Cognitive impairment predictive of dementia (including Parkinson's disease dementia) or other cognitive dysfunction as judged by the investigator, e.g., as defined by Montreal Cognitive Assessment (MoCA) score ≤ 24, or evidence of major neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria.
- Major medical or psychiatric disorder (e.g., depression (Montgomery-Asberg Depression Rating Scale (MADRS) >20) or psychosis), or other disease making the patient unsuited for participation in the study, as judged by the investigator.
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 |
|---|---|---|
| No treatment givenParticipants will not receive any investigational treatment in this study. | Other | Participants with Parkinson's disease |
Primary outcome
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF state
Time frame: From baseline (week 0) to end of study (13 to 104 weeks from baseline)
Measured as score. MDS-UPDRS consists of 4 parts - has 65 items/questions in total. Part III assesses the motor function of the patient at the time of the visit conducted in both the OFF and ON state. Each item will receive a score ranging from 0 to 4, where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
2 secondary outcomes
Change in MDS-UPDRS Part III (motor score) in OFF state
Time frame: From last medication adjustment (between week 0 and week 104) to end of study (13 to 104 weeks from baseline)
Is the patient interested in being considered for participation in a cell therapy transplantation study (yes/no)
Time frame: At end of study (13 to 104 weeks from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Novo Nordisk A/S at 8 sites in 4 countries.
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 7 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Sweden, United Kingdom, Japan. 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?
This study is still under way. Results are not available in the source record yet.
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 in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF state (time frame: From baseline (week 0) to end of study (13 to 104 weeks from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.