Parkinson DiseasePhase 3TEMPO-2NCT04223193
Flexible-Dose Trial in Early Parkinson's Disease (PD)
A Phase 3 study testing Tavapadon in people with Parkinson Disease, run by AbbVie at 53 sites in 13 countries.
Trial summary
The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Tavapadon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 53 sitesin 13 countries
- Study dates
- 6 Jan 2020to 1 Oct 2024
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF).
- Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment.
- Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria.
- Participants with modified Hoehn and Yahr stage 1, 1.5, or 2.
- Participants with disease duration (from time of diagnosis) of less than (<) 3 years and disease progression in the 3 years before signing the ICF.
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- Participants with an MDS-UPDRS Part II score >=2 and Part III score >=10 at the Screening Visit and at the Baseline Visit.
- Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management.
- Participants who are treatment naive or have a history of prior incidental treatment with dopaminergic agents (including L-Dopa and dopamine receptor agonist medications) for <3 months in total but not within 2 months of the Baseline Visit. Prior and concurrent use of MAO-B inhibitors is permitted if use was initiated >90 days before the Baseline Visit and the dosage will remain stable for the duration of the trial (ie, no change in the MAO-B inhibitor dose is permitted during the trial).
- Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.
Who cannot join
- Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post stroke parkinsonism).
- Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages.
- Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5).
- Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures.
- Participants with a history of psychosis or hallucinations within the previous 12 months.
- Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
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- Participants with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days).
- Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial.
- Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding).
- Participants who have a positive result for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies at screening.
- Participants with a history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical intervention; second- or third-degree atrioventricular block; sick sinus syndrome; severe or unstable angina; or congestive heart failure within the last 12 months. A recent (less than or equal to [<=] 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control.
- Participants with a history of neuroleptic malignant syndrome.
- Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration).
- Participants with a positive urine drug screen for illicit drugs are excluded and may not be retested or rescreened. Participants with a positive urine drug screen resulting from use of marijuana (any Tetrahydrocannabinol [THC]-containing product), prescription, or over-the-counter medications or products that, in the investigator's documented opinion, do not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor.
- Participants with a Montreal Cognitive Assessment (MoCA) score <26.
- Participants with clinically significant orthostatic hypotension (eg, syncope).
- Participants with a 12-lead ECG demonstrating a QTcF interval >450 msec.
- Participants with moderate or severe renal impairment (creatinine clearance as estimated by Cockcroft-Gault formula <30 mL/min or on dialysis).
- Participants with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary:
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >=3 × Upper Limit Normal (ULN).
- Total bilirubin >=1.5 × ULN. Participants with a history of Gilbert's syndrome may be eligible provided they have a value <ULN for direct bilirubin.
- Participants with other abnormal laboratory test results, vital sign results, or ECG findings unless, in the judgment of the investigator, the findings are not medically significant and would not impact the safety of the participants or the interpretation of the trial results.
Trial locations and contacts
53 sites in 13 countries.
53 sites in 13 countries
United States18 sites
Albany, New York
Albany, New York, 12208
Boca Raton, Florida
Boca Raton, Florida, 33487
Cincinnati, Ohio
Cincinnati, Ohio, 45212
Cleveland, Ohio
Cleveland, Ohio, 44195
Cypress, Texas
Cypress, Texas, 77429
Fresno, California
Fresno, California, 93710
Houston, Texas
Houston, Texas, 77030
Kirkland, Washington
Kirkland, Washington, 98034
Lubbock, Texas
Lubbock, Texas, 79410
Maitland, Florida
Maitland, Florida, 32751
Memphis, Tennessee
Memphis, Tennessee, 38157
Boston Neuro Research Center
North Dartmouth, Massachusetts, 02747
Ocala, Florida
Ocala, Florida, 34470
Richmond, Virginia
Richmond, Virginia, 23229
Richmond, Virginia
Richmond, Virginia, 23233
Round Rock, Texas
Round Rock, Texas, 78681
Syracuse, New York
Syracuse, New York, 13210
Winter Park, Florida
Winter Park, Florida, 32792
Italy5 sites
Cassino
Cassino, Cassino, 03043
Milano
Milan, Milano, 20132
Rome
Rome, Rome, 00133
Rozzano Milano
Rozzano, 20089
Torino
Torino, 10126
Poland5 sites
Centrum Medyczne NEUROMED
Bydgoszcz, 85-163
Katowice
Katowice, Katowice, 40-097
Cracow
Krakow, Cracow, 31-505
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, 20-701
Siemianowice Slaskie
Siemianowice Śląskie, Siemianowice Slaskie, 41-100
Germany4 sites
Berlin
Berlin, State of Berlin, 12163
Bochum
Bochum, Bochum, 44791
Gera
Gera, Gera, 07551
Muenchen
München, Muenchen, 81377
France3 sites
Marseille, France
Marseille, France, 13385
Nantes CEDEX 1
Nantes, Nantes, 44093
Toulouse Cedex 9
Toulouse, Toulouse, 31059
Hungary3 sites
Budapest
Budapest, Budapest, 1135
Pecs
Pécs, Hungary, 7623
Tatabanya
Tatabánya, 2800
South Korea3 sites
Haeundae-gu, Busan
Busan, Haeundae-gu, 48108
Dongdaemun-gu, Seoul
Seoul, Dongdaemun-gu, 02447
Songpa-gu, Seoul
Seoul, Songpa-gu, 05505
Thailand3 sites
Khlong Luang, Pathum Thani
Khlong Luang, Changwat Pathum Thani, 12120
Nai Muang, Ubon Ratchathani
Nai Muang, Changwat Ubon Ratchathani, 34000
Ratchathewi, Bangkok
Ratchathewi, Bangkok, 10400
Ukraine3 sites
Kiev
Kiev, Kyiv City, 04114
Lviv
Lviv, Lviv Oblast, 79010
Vinnitsa
Vinnitsa, Vinnitsa, 21050
Spain2 sites
Barcelona
Barcelona, Barcelona, 08035
Móstoles, Madrid
Madrid, Madrid, 28938
Taiwan2 sites
Zhongzheng, Taipei
Zhongzheng, Taipei, 100225
Zhongzheng, Taipei
Zhongzheng, Taipei, 112062
Australia1 site
Macquarie Park, New South Wales
Sydney, New South Wales, 2109
About this study
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)
The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.
- Conditions
- Parkinson Disease
- Being tested
- Tavapadon, Placebo
- Keywords
- Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TavapadonDrug
Also called PF-06649751, CVL-751
Participants will be randomized to receive tavapadon 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks.
PlaceboDrug
Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tavapadon | Experimental | Participants will receive tavapadon tablet titrated up to 15 milligram (mg) once daily (QD) orally for 27 weeks. Receives: Drug: Tavapadon |
| Placebo | Placebo comparator | Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
Measured: Week 26
Secondary outcomes (12)
Change From Baseline in the MDS-UPDRS Part II Score
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function.
Measured: Week 26
Percentage of Responders With "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC)
The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed.
Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Measured: Week 26
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
Measured: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 1, 2, and 3 combined is the sum of Part 1, Part 2, and Part 3 scores at each assessment time for each participant. The combined score assesses 44 items with score range: 0-236.
Measured: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function.
Measured: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
The Global Impression - Severity of Illness (CGI-S) Score is a clinician's impression of a participant's severity of illness on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (normal) to 7 (among the most extremely ill participants).
Higher values represent a worse outcome.
Measured: Week 5, 8, 11, 14, 18, 22, 26, and 27
Clinical Global Impression - Improvement (CGI-I) Score
The Clinical Global Impression - Improvement (CGI-I) Score is a clinician's impression of how much the participant's illness has improved or worsened relative to the baseline on a 7-point scale. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Measured: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the PGIC Score
The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" was assessed.
Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Measured: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the Epworth Sleepiness Scale (ESS)
The ESS is an 8-question, participant questionnaire that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated on a 4-point (0-3) scale with scores ranging from 0 (would never nod off) to 3 (high chance of nodding off). Higher values represent a worse outcome. A negative change from baseline represents an improvement in daytime sleepiness. The total ESS score range was 0 - 24.
Measured: Week 26
Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
QUIP-RS is a questionnaire for impulse-compulsive disorders in Parkinson's disease rating scale to assess impulse control disorders (ICD). The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/ desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 [0 means "never" and 4 means "very often"] for each question) to gauge the frequency of behaviors.
Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112. A higher score indicating greater severity of symptoms. A negative change from baseline represents an improvement in ICDs.
Measured: Week 26
Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation (SI) categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.
Measured: Week 27
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Measured: From first dose of study drug until 190 days following last dose of study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start6 Jan 2020
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223193
- Sponsor's protocol ID
- CVL-751-PD-002
- Other IDs
- 2019-002950-22, 2019
- Acronym
- TEMPO-2
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2020
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez HH, Bhatia P, Cloud L, Fietzek UM, Matarazzo M, Molho E, Peckham E, Tarakad A, Combs C, Leoni M, Chang I, Tringali S, Boiser J, Sanchez R, Zadikoff C. Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial. Lancet Neurol. 2026 Aug;25(8):721-730. doi: 10.1016/S1474-4422(26)00215-2.
PubMed 42456682
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)
- ClinicalTrials.gov ID
- NCT04223193
- Acronym / sponsor ID
- TEMPO-2 / CVL-751-PD-002
- Conditions
- Parkinson Disease
- Keywords
- Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tavapadon | Experimental | Drug: TavapadonParticipants will receive tavapadon tablet titrated up to 15 milligram (mg) once daily (QD) orally for 27 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matching to tavapadon tablet QD orally for 27 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female participants aged 40 to 80 years, inclusive, at the time of signing the informed consent form (ICF).
- Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment.
- Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria.
- Participants with modified Hoehn and Yahr stage 1, 1.5, or 2.
Key exclusion criteria (22 listed)
- Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post stroke parkinsonism).
- Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages.
- Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5).
- Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures.
- Participants with a history of psychosis or hallucinations within the previous 12 months.
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 |
|---|---|---|
| TavapadonAlso: PF-06649751, CVL-751Participants will be randomized to receive tavapadon 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks. | Drug | Tavapadon |
| PlaceboParticipants will receive placebo matching to tavapadon QD orally for 27 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score
Time frame: Week 26
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Part 4 was not collected in this trial). Each item has 0-4 rating on scale from 0 (normal) to 4 (severe). Higher values represent a worse outcome. A negative change from baseline represents an improvement in motor function. Parts 2 and 3 combined is the sum of Part 2 score and Part 3 score at each assessment time for each participant. The combined score assesses 31 items with score range: 0-184.
12 secondary outcomes
Change From Baseline in the MDS-UPDRS Part II Score
Time frame: Week 26
Percentage of Responders With "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC)
Time frame: Week 26
Change From Baseline in the MDS-UPDRS Parts II and III Combined Score
Time frame: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score
Time frame: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score
Time frame: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Time frame: Week 5, 8, 11, 14, 18, 22, 26, and 27
Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the PGIC Score
Time frame: Week 5, 8, 11, 14, 18, 22, 26, and 27
Change From Baseline in the Epworth Sleepiness Scale (ESS)
Time frame: Week 26
Change From Baseline in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
Time frame: Week 26
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Week 27
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug until 190 days following last dose of study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42456682Fernandez HH, Bhatia P, Cloud L, Fietzek UM, Matarazzo M, Molho E, Peckham E, Tarakad A, Combs C, Leoni M, Chang I, Tringali S, Boiser J, Sanchez R, Zadikoff C. Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial. Lancet Neurol. 2026 Aug;25(8):721-730. doi: 10.1016/S1474-4422(26)00215-2.
- Individual participant dataSharing planned: No
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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.
ABBVIE Inc. study director
AbbVie
53 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tavapadon in people with Parkinson Disease, run by AbbVie at 53 sites in 13 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 10 inclusion and 22 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Italy, Poland, Germany, France and 8 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2025). 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 the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score (time frame: Week 26). 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 NCT04223193, which also lists 1 linked publication.
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 21 Nov 2025.