Trial · NCT04542499
Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)
NCT04542499, Phase 3, Completed, AbbVie; results first posted 2025-03-25
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3). Trials, record NCT04542499. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04542499
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)
- NCT number
- NCT04542499
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 507 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Parkinson Disease
- Interventions
- Tavapadon, Placebo
- First posted
- 2020-09-09
- Last updated
- 2025-04-04
- Other registries' IDs
- eudract:2019-002951-40
- Results first posted
- 2025-03-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Week 26 | The Hauser diary 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. The total "on" time without troublesome dyskinesia will be assessed and reported at endpoint. |
| Secondary | Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | Week 26 | The Hauser diary 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. The total daily "Off" time will be assessed and reported at endpoint. |
| Secondary | Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Week 2, 5, 8, 11, 14, 18, 22, and 26 | The Hauser diary 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. The total "on" time without troublesome dyskinesia will be assessed and reported at different time points. |
| Secondary | Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | Week 2, 5, 8, 11, 14, 18, 22, and 26 | The Hauser diary 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. The total daily "Off" time will be assessed and reported at different time points. |
| Secondary | Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score | Week 26 | The 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Week 26 | Population includes subjects who received at least one dose of study drug and had available data for analysis. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Daily Off Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | Week 26 | Population includes subjects who received at least one dose of study drug and had available data for analysis. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Week 2, 5, 8, 11, 14, 18, 22, and 26 | Population includes subjects who received at least one dose of study drug and had available data for analysis. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Daily Off Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | Week 2, 5, 8, 11, 14, 18, 22, and 26 | Population includes subjects who received at least one dose of study drug and had available data for analysis. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score | Week 26 | Population includes subjects who received at least one dose of study drug and had available data for analysis. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Placebo | 0.619 | Standard Error 0.188 | hours | |
| Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Tavapadon | 1.721 | Standard Error 0.207 | hours | |
| Change From Baseline in Total Daily Off Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | Placebo | -0.933 | Standard Error 0.182 | hours | |
| Change From Baseline in Total Daily Off Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary) | Tavapadon | -1.876 | Standard Error 0.200 | hours | |
| Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Placebo | Week 2 | 0.535 | Standard Error 0.133 | hours |
| Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Tavapadon | Week 2 | 0.305 | Standard Error 0.133 | hours |
| Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Placebo | Week 5 | 0.516 | Standard Error 0.148 | hours |
| Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Tavapadon | Week 5 | 0.616 | Standard Error 0.151 | hours |
| Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Placebo | Week 8 | 0.470 | Standard Error 0.162 | hours |
| Change From Baseline in the Total On Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) | Tavapadon | Week 8 | 1.052 | Standard Error 0.168 | hours |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 255 | |
| Overall Study | STARTED | Tavapadon | 252 | |
| Overall Study | COMPLETED | Placebo | 206 | |
| Overall Study | COMPLETED | Tavapadon | 159 | |
| Overall Study | NOT COMPLETED | Placebo | 49 | |
| Overall Study | NOT COMPLETED | Tavapadon | 93 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo | 1 | 255 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Tavapadon | 6 | 252 | 6 |
| other | CONSTIPATION | Gastrointestinal disorders | Placebo | 8 | 255 | 9 |
| other | CONSTIPATION | Gastrointestinal disorders | Tavapadon | 10 | 252 | 10 |
| other | DRY MOUTH | Gastrointestinal disorders | Placebo | 2 | 255 | 2 |
| other | DRY MOUTH | Gastrointestinal disorders | Tavapadon | 7 | 252 | 7 |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 11 | 255 | 14 |
| other | NAUSEA | Gastrointestinal disorders | Tavapadon | 36 | 252 | 44 |
| other | ASTHENIA | General disorders | Placebo | 0 | 255 | 0 |
| other | ASTHENIA | General disorders | Tavapadon | 8 | 252 | 8 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 255 |
| Total, all-cause mortality | Tavapadon | 1 | 252 |
| Total, other adverse events | Placebo | 90 | 255 |
| Total, other adverse events | Tavapadon | 130 | 252 |
| Total, serious adverse events | Placebo | 14 | 255 |
| Total, serious adverse events | Tavapadon | 17 | 252 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41860544 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tavapadon vs Placebo: deaths from any cause | Trial comparisons |
| Tavapadon vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04542499
GET https://conductscience.org/api/trials/v1/NCT04542499/results?page=2