Trial · NCT04223193
Flexible-Dose Trial in Early Parkinson's Disease (PD)
NCT04223193, Phase 3, Completed, AbbVie; results first posted 2025-11-21
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Flexible-Dose Trial in Early Parkinson's Disease (PD). Trials, record NCT04223193. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04223193
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flexible-Dose Trial in Early Parkinson's Disease (PD)
- NCT number
- NCT04223193
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 304 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Parkinson Disease
- Interventions
- Tavapadon, Placebo
- First posted
- 2020-01-10
- Last updated
- 2025-11-21
- Other registries' IDs
- eudract:2019-002950-22
- Results first posted
- 2025-11-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score | 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. |
| Secondary | Change From Baseline in the MDS-UPDRS Part II Score | 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. |
| Secondary | Percentage of Responders With "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC) | Week 26 | 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. |
| Secondary | Change From Baseline in the MDS-UPDRS Parts II and III Combined Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | 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. |
| Secondary | Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | 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. |
| Secondary | Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | 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. |
| Secondary | Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | 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. |
| Secondary | Clinical Global Impression - Improvement (CGI-I) Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | 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. |
| Secondary | Change From Baseline in the PGIC Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | 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. |
| Secondary | Change From Baseline in the Epworth Sleepiness Scale (ESS) | Week 26 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score | Week 26 | mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline MDS-UPDRS assessment, and had available data for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MDS-UPDRS Part II Score | Week 26 | mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline MDS-UPDRS assessment, and had available data for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders With Much Improved or Very Much Improved on Participant Global Impression of Change (PGIC) | Week 26 | mITT Population includes subjects who receive at least 1 dose of study drug and have both a baseline and at least 1 postbaseline PGIC assessment, and had available data for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the MDS-UPDRS Parts II and III Combined Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | mITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MDS-UPDRS Parts I, II and III Combined Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | mITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the MDS-UPDRS Parts I, II and III Individual Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | mITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | mITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression - Improvement (CGI-I) Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | mITT Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the PGIC Score | Week 5, 8, 11, 14, 18, 22, 26, and 27 | mITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Epworth Sleepiness Scale (ESS) | Week 26 | FAS population includes all randomized participants who received at least 1 dose of study drug, and had available data for analysis. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group150
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 Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score | Placebo | -1.2 | Standard Error 0.89 | score on a scale | |
| Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score | Tavapadon | -10.3 | Standard Error 0.99 | score on a scale | |
| Change From Baseline in the MDS-UPDRS Part II Score | Placebo | 0.0 | Standard Error 0.30 | score on a scale | |
| Change From Baseline in the MDS-UPDRS Part II Score | Tavapadon | -1.5 | Standard Error 0.33 | score on a scale | |
| Percentage of Responders With Much Improved or Very Much Improved on Participant Global Impression of Change (PGIC) | Placebo | 25 | Participants | ||
| Percentage of Responders With Much Improved or Very Much Improved on Participant Global Impression of Change (PGIC) | Tavapadon | 46 | Participants | ||
| Change From Baseline in the MDS-UPDRS Parts II and III Combined Score | Placebo | Week 5 | -2.1 | Standard Error 0.58 | score on a scale |
| Change From Baseline in the MDS-UPDRS Parts II and III Combined Score | Tavapadon | Week 5 | -5.5 | Standard Error 0.63 | score on a scale |
| Change From Baseline in the MDS-UPDRS Parts II and III Combined Score | Placebo | Week 8 | -2.4 | Standard Error 0.64 | score on a scale |
| Change From Baseline in the MDS-UPDRS Parts II and III Combined Score | Tavapadon | Week 8 | -8.5 | Standard Error 0.69 | score on a scale |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 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 | 153 | |
| Overall Study | STARTED | Tavapadon | 151 | |
| Overall Study | COMPLETED | Placebo | 130 | |
| Overall Study | COMPLETED | Tavapadon | 94 | |
| Overall Study | NOT COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | Tavapadon | 57 |
Source ClinicalTrials.gov
Adverse events80
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 | CONSTIPATION | GASTROINTESTINAL DISORDERS | Placebo | 3 | 153 | 3 |
| other | CONSTIPATION | GASTROINTESTINAL DISORDERS | Tavapadon | 6 | 151 | 6 |
| other | DIARRHOEA | GASTROINTESTINAL DISORDERS | Placebo | 2 | 153 | 2 |
| other | DIARRHOEA | GASTROINTESTINAL DISORDERS | Tavapadon | 4 | 151 | 5 |
| other | DRY MOUTH | GASTROINTESTINAL DISORDERS | Placebo | 1 | 153 | 1 |
| other | DRY MOUTH | GASTROINTESTINAL DISORDERS | Tavapadon | 5 | 151 | 5 |
| other | DYSPEPSIA | GASTROINTESTINAL DISORDERS | Placebo | 2 | 153 | 3 |
| other | DYSPEPSIA | GASTROINTESTINAL DISORDERS | Tavapadon | 6 | 151 | 6 |
| other | GASTROOESOPHAGEAL REFLUX DISEASE | GASTROINTESTINAL DISORDERS | Placebo | 2 | 153 | 2 |
| other | GASTROOESOPHAGEAL REFLUX DISEASE | GASTROINTESTINAL DISORDERS | Tavapadon | 6 | 151 | 7 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 153 |
| Total, all-cause mortality | Tavapadon | 0 | 151 |
| Total, other adverse events | Placebo | 59 | 153 |
| Total, other adverse events | Tavapadon | 99 | 151 |
| Total, serious adverse events | Placebo | 2 | 153 |
| Total, serious adverse events | Tavapadon | 7 | 151 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42456682 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tavapadon vs Placebo: Percentage of Responders With Much Improved or Very Much Improved on Participant Global Impression of Change (PGIC) | Trial comparisons |
| 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/NCT04223193
GET https://conductscience.org/api/trials/v1/NCT04223193/results?page=2