Open-label Trial in Parkinson's Disease (PD)

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified November 2025 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT04760769
Other Study ID Numbers:
CVL-751-PD-004
First Submitted
February 11, 2021
First Posted
February 17, 2021
Last Update Posted
December 22, 2025
Last Verified
November 2025

ClinicalTrials.gov processed this data on December 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Parkinson Disease
Drug: Tavapadon

Study Design

Study TypeInterventional
Actual Enrollment992 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official Title58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
Study Start DateFebruary 23, 2021
Actual Primary Completion DateNovember 30, 2025
Actual Study Completion DateNovember 30, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Tavapadon
Participants will receive a Tavapadon tablet at a dose of 5 milligrams (mg) to 15 mg once daily (QD) orally during 58-week treatment period.
Drug: Tavapadon
Participants will receive Tavapadon at a dose of (5 to 15) mg QD, orally during a 58-week treatment period.

Outcome Measures

Primary Outcome Measures
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, Vital Signs, Physical and Neurological evaluations and ECGs will be reported as TEAEs.
  2. Number of Participants Who Discontinued Study Treatment
    A participant may discontinue the study treatment due to any of the following reasons: adverse event, death, worsening of PD symptoms to such an extent that, in the judgement of the investigator, the participant requires additional anti-PD medications, treatment with a prohibited concomitant medication, noncompliance with the trial schedule or procedures, withdrawal of consent, pregnancy, investigator discretion.
  3. Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS)
    QUIP-RS is a global screening instrument that assesses impulse control disorders (ICDs) and related disorders (punding, hobbyism, and dopamine dysregulation syndrome) in participants with PD. 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.
  4. Epworth Sleepiness Scale (ESS)
    ESS is a scale 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 as 0 = would never nod off, 1 = slight chance of nodding off, 2 = moderate chance of nodding off, or 3 = high chance of nodding off. A score greater than or equal to (\> =) 10 indicates that the participant may need to get more sleep, improve sleep practices, or seek medical attention to determine why he or she is sleepy.
  5. Columbia-Suicide Severity Rating Scale (C-SSRS)
    C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
  6. Study Medication Withdrawal Questionnaire (SMWQ)
    SMWQ is a questionnaire to assess withdrawal symptoms subsequent to completion of dosing with Investigational medicinal product (IMP). The SMWQ is a modification of the Amphetamine Withdrawal Questionnaire, in which the first question "Have you been craving amphetamine or methamphetamine?" is replaced with "Have you been craving the trial medication?" This change is intended to prevent bias by implying that the trial medication might be an amphetamine or amphetamine-like stimulant when presented with the survey. Participants will complete the SMWQ onsite when they are at a designated trial visit; on days when the participant is not onsite, they will complete the SMWQ remotely.
  7. Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III
    The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Part I, non-motor aspects of experiences of daily living, comprises 13 items, 6 of which are rated by the physician (Part IA) and 7 of which are rated by the participant (Part IB). Part II, motor aspects of experiences of daily living, comprises 13 items that are rated by the participant. Part III, motor examination, comprises 18 items that are assessed by the investigator (resulting in 33 scores by location and lateralization). Part IV, motor complications, comprises 6 item (3 items for dyskinesia and 3 items for fluctuation) and requires the physician to use historical and objective information to assess dyskinesia and motor fluctuations. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Change from baseline in MDS-UPDRS parts I, II and III combined score will be assessed.
  8. Change From Baseline in the Hauser diary
    The Hauser diary (Hauser et al, 2000) assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep.
  9. Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index
    EQ-5D-5L is a survey instrument used for participant-reported outcome that measures health in 5 dimensions. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels of perceived problems (1 = no problem, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = extreme problems). Participant selects an answer for each of 5 dimensions considering the response that best matches his/her health "today". The digits for the 5 dimensions are combined into a 5-digit number that describes the participant's health state.
  10. Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS)
    EQ-5D-5L VAS is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. The EQ-5D-5L VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Rollover participants are eligible for the study if they met the following inclusion criteria:
Participants who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 (NCT04201093) or Trial CVL-751 PD-003 (NCT04542499) or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 (NCT04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover participants from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
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 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.
Participant who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial. Key
Exclusion Criteria
Key Inclusion Criteria: Rollover participants are eligible for the study if they met the following inclusion criteria:
Participants who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 (NCT04201093) or Trial CVL-751 PD-003 (NCT04542499) or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 (NCT04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover participants from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
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 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.
Participant who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial. Key Exclusion criteria: Rollover participants are excluded from the trial if any of the following met:
Participants who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial
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.
Participants who had previously been enrolled in this open-label trial and had subsequently withdrawn.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
Birmingham, Alabama | Birmingham Alabama, United States, 35233Pheonix, Arizona | Phoenix Arizona, United States, 85004Little Rock, Arkansas | Little Rock Arkansas, United States, 72205Fountain Valley, California | Fountain Valley California, United States, 92708Fresno, California | Fresno California, United States, 93710Los Angeles, California | Los Angeles California, United States, 90048Pasadena, California | Pasadena California, United States, 91105Reseda, California | Reseda California, United States, 91335Englewood, Colorado | Englewood Colorado, United States, 80113Florida, United States | Adventura Florida, United States, 33180Boca Raton, Florida | Boca Raton Florida, United States, 33486Coral Springs, Florida | Coral Springs Florida, United States, 33067Maitland, Florida | Maitland Florida, United States, 32751Naples, Florida | Naples Florida, United States, 34102Ocala, Florida | Ocala Florida, United States, 34470Port Charlotte, Florida | Port Charlotte Florida, United States, 33980Port Orange, Florida | Port Orange Florida, United States, 32127Tampa, Florida | Tampa Florida, United States, 33615Winter Park, Florida | Winter Park Florida, United States, 32792Augusta, Georgia | Augusta Georgia, United States, 30912Chicago, Illinois | Chicago Illinois, United States, 60612Winfield, Illinois | Winfield Illinois, United States, 60190Kansas City | Kansas City Kansas, United States, 66160Lexington, Kentucky | Lexington Kentucky, United States, 40536Scarborough, Maine | Scarborough Maine, United States, 04074Boston, Massachusettes | Boston Massachusetts, United States, 02215Lawrence, Massachusetts | Lawrence Massachusetts, United States, 01843East Lansing, Michigan | East Lansing Michigan, United States, 48824West Bloomfield | West Bloomfield Michigan, United States, 48322Las Vegas, Nevada | Las Vegas Nevada, United States, 89106Camden, New Jersey | Camden New Jersey, United States, 08103Albany, New York | Albany New York, United States, 12208Syracuse, New York | Syracuse New York, United States, 13210Asheville, North Carolina | Asheville North Carolina, United States, 28806Durham, North Carolina | Durham North Carolina, United States, 27705Cincinnati, Ohio | Cincinnati Ohio, United States, 45212Cleveland, Ohio | Cleveland Ohio, United States, 44195Columbus, Ohio | Columbus Ohio, United States, 43221Dayton, Ohio | Dayton Ohio, United States, 45459Toledo, Ohio | Toledo Ohio, United States, 43614Philadelphia, Pennsylvania | Philadelphia Pennsylvania, United States, 19107Memphis, Tennessee | Memphis Tennessee, United States, 38157Georgetown, Texas | Georgetown Texas, United States, 78628Houston, Texas | Houston Texas, United States, 77030Lubbock, Texas | Lubbock Texas, United States, 79410Round Rock, Texas | Round Rock Texas, United States, 78681Burlington, Vermont | Burlington Vermont, United States, 05401Richmond, Virginia | Richmond Virginia, United States, 23229Richmond, Virginia | Richmond Virginia, United States, 23233Virginia Beach, Virginia | Virginia Beach Virginia, United States, 23456Kirkland, Washington | Kirkland Washington, United States, 98034Spokane, Washington | Spokane Washington, United States, 99202Erina, New South Wales | Erina New South Wales, Australia, 2250Kogarah | Kogarah New South Wales, Australia, 2217Macquarie Park, New South Wales | Sydney New South Wales, Australia, 2109Woolloongabba, Queensland | Woolloongabba Queensland, Australia, 4102Clayton, Victoria | Clayton Victoria, Australia, 3168Parkville, Victoria | Parkville Victoria, Australia, 3050Medical center VITA1, Pleven | Pleven , Bulgaria, 5800Pleven, Bulgaria | Pleven , Bulgaria, 5800Pleven | Pleven , Bulgaria, 5800Multiprofile Hospital, Sofia | Sofia , Bulgaria, 1113Sofia | Sofia , Bulgaria, 1142Sofia | Sofia , Bulgaria, 1407Sofia | Sofia , Bulgaria, 1431Ottawa, Ontario | Ottawa Ontario, Canada, K1Y4E9Toronto, Ontario | Toronto Ontario, Canada, M5T 2S8Chocen | Choceň Chocen, Czechia, 56501Prague, Czech Republic | Prague Czech Republic, Czechia, 150 00Prague, | Prague , Czechia, 100 00Prague, | Prague , Czechia, 160 00Rychnov nad Kněžnou | Rychnov nad Kněžnou , Czechia, 516 01Creteil, | Créteil Creteil, France, 94010Boulevard Pinel, Bron | Bron , France, 69500Grenoble cedex | Grenoble , France, 38043Nancy | Nancy , France, 54035Nîmes cedex 09 | Nîmes , France, 30029Strasbourg | Strasbourg , France, 67098Toulouse Cedex 9 | Toulouse , France, 31059Muenster | Münster Muenster, Germany, 48149Bad Homburg | Bad Homburg , Germany, 61348Berlin | Berlin , Germany, 12163Bochum | Bochum , Germany, 44791Gera | Gera , Germany, D-07551Haag in Oberbayern | Haag in Oberbayern , Germany, 83527Klinikum rechts der Isar der TU München | Munich , Germany, 81675Muenchen | München , Germany, 81377Stadtroda | Stadtroda , Germany, 07646Budapest | Budapest , Hungary, 1135Pecs | Pécs , Hungary, 7623Tatabanya | Tatabánya , Hungary, 2800Haifa | Haifa , Israel, 3109601Petah Tiqva | Petah Tikva , Israel, 49100Ramat Gan | Ramat Gan , Israel, 5265601Shoham | Shoham , Israel, 6083531Tel Aviv | Tel Aviv , Israel, 6100000Ancona | Ancona , Italy, 60126Cassino | Cassino , Italy, 03043Milano, Italy | Milan , Italy, 20126Milano | Milan , Italy, 20132Padova | Padova , Italy, 35128Pisa | Pisa , Italy, 56126Rome | Rome , Italy, 00133Rome | Rome , Italy, 00163Rome | Rome , Italy, 00179Torino | Torino , Italy, 10126Cracow | Krakow Cracow, Poland, 31-505Siemianowice Slaskie | Siemianowice Śląskie Siemianowice Slaskie, Poland, 41-100Centrum Medyczne NEUROMED | Bydgoszcz , Poland, 85-163Katowice | Katowice , Poland, 40-097Katowice | Katowice , Poland, 40-123Kraków | Krakow , Poland, 30-510Krakow | Krakow , Poland, 30-539Krakow | Krakow , Poland, 30-721Lublin | Lublin , Poland, 20-016Centrum Medyczne Hope Clinic Sebastian Szklener | Lublin , Poland, 20-701Warsaw | Warsaw , Poland, 01-868Singua | Warsaw , Poland, 02-777Belgrade, Serbia | Belgrade , Serbia, 11000Belgrade, | Belgrade , Serbia, 11000Belgrade | Belgrade , Serbia, 11000Belgrade, Kragujevac | Belgrade , Serbia, 11060Elche | Elche Alicante, Spain, 03203Barcelona | Barcelona , Spain, 08035Barcelona | Barcelona , Spain, 08041Sant Cugat del Vallés Barcelona | Barcelona , Spain, 08190San Sebastian | Donostia / San Sebastian , Spain, 20009Madrid | Madrid , Spain, 28006Móstoles, Madrid | Madrid , Spain, 28938Pamplona | Pamplona , Spain, 31008Sevilla | Seville , Spain, 41013Terrassa | Terrassa , Spain, 08222Valencia | Valencia , Spain, 46026Zaporiizhzhya | Zaporizhzhya Zaporiizhzhya, Ukraine, 69600Zaporozhya | Zaporizhzhya Zaporozhya, Ukraine, 69000Dnipro | Dnipro , Ukraine, 49005Dnipro | Dnipro , Ukraine, 49027Lviv | Lviv , Ukraine, Vinnitsa | Vinnitsa , Ukraine, 21050Medical Center, Zaporizhzhya | Zaporizhzhya , Ukraine, 69035
Investigators
Study Director: ABBVIE Inc., AbbVie