Trial · NCT00974974
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
NCT00974974, Phase 3, Completed, Impax Laboratories, LLC; results first posted 2016-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD). Trials, record NCT00974974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00974974
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
- NCT number
- NCT00974974
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 471 participants, actual
- Lead sponsor
- Impax Laboratories, LLC
- Conditions
- Parkinson's Disease
- Interventions
- IPX066, IR CD-LD
- First posted
- 2009-09-11
- Last updated
- 2020-08-11
- Results first posted
- 2016-01-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of "Off" Time During Waking Hours at End of Study | 22 weeks | Percentage of "off" time during waking hours at end of study is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)." |
| Secondary | "Off" Time | 22 weeks | "Off" time hours is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)." |
| Secondary | "On" Time Without Troublesome Dyskinesia | 22 weeks | "On" time without troublesome dyskinesiais measured by using the Parkinson's disease diary. "On" time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living." |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Off Time During Waking Hours at End of Study | 22 weeks | All randomized subjects | percentage | MEAN |
| SECONDARY | Off Time | 22 weeks | All randomized subjects | hours | MEAN |
| SECONDARY | On Time Without Troublesome Dyskinesia | 22 weeks | All randomized subjects | hours | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Off Time During Waking Hours at End of Study | IPX066 | 23.82 | Standard Deviation 14.91 | percentage | |
| Percentage of Off Time During Waking Hours at End of Study | IR CD-LD (Active Comparator) | 29.79 | Standard Deviation 15.81 | percentage | |
| Off Time | IPX066 | 3.87 | Standard Deviation 2.46 | hours | |
| Off Time | IR CD-LD (Active Comparator) | 4.88 | Standard Deviation 2.71 | hours | |
| On Time Without Troublesome Dyskinesia | IPX066 | 11.84 | Standard Deviation 2.96 | hours | |
| On Time Without Troublesome Dyskinesia | IR CD-LD (Active Comparator) | 10.91 | Standard Deviation 2.82 | hours |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| IR CD-LD Dose Adjustment | STARTED | IPX066 | 0 | |
| IR CD-LD Dose Adjustment | STARTED | IR CD-LD (Active Comparator) | 471 | |
| IR CD-LD Dose Adjustment | COMPLETED | IPX066 | 0 | |
| IR CD-LD Dose Adjustment | COMPLETED | IR CD-LD (Active Comparator) | 450 | |
| IR CD-LD Dose Adjustment | NOT COMPLETED | IPX066 | 0 | |
| IR CD-LD Dose Adjustment | NOT COMPLETED | IR CD-LD (Active Comparator) | 21 | |
| IPX066 Dose Conversion | STARTED | IPX066 | 450 | |
| IPX066 Dose Conversion | STARTED | IR CD-LD (Active Comparator) | 0 | |
| IPX066 Dose Conversion | COMPLETED | IPX066 | 393 | |
| IPX066 Dose Conversion | COMPLETED | IR CD-LD (Active Comparator) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events96
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 | Insomnia | Psychiatric disorders | IPX066 | 7 | 201 | |
| other | Insomnia | Psychiatric disorders | Carbidopa-Levodopa | 2 | 192 | |
| other | nausea | Gastrointestinal disorders | IPX066 | 6 | 201 | |
| other | nausea | Gastrointestinal disorders | Carbidopa-Levodopa | 3 | 192 | |
| other | Fall | Injury, poisoning and procedural complications | IPX066 | 6 | 201 | |
| other | Fall | Injury, poisoning and procedural complications | Carbidopa-Levodopa | 4 | 192 | |
| other | Dizziness | Nervous system disorders | IPX066 | 5 | 201 | |
| other | Dizziness | Nervous system disorders | Carbidopa-Levodopa | 2 | 192 | |
| other | Dyskinesia | Nervous system disorders | IPX066 | 5 | 201 | |
| other | Dyskinesia | Nervous system disorders | Carbidopa-Levodopa | 2 | 192 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IPX066 | ||
| Total, all-cause mortality | Carbidopa-Levodopa | ||
| Total, other adverse events | IPX066 | 57 | 201 |
| Total, other adverse events | Carbidopa-Levodopa | 50 | 192 |
| Total, serious adverse events | IPX066 | 11 | 201 |
| Total, serious adverse events | Carbidopa-Levodopa | 5 | 192 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| IPX066 vs Carbidopa-Levodopa: serious adverse events |
Source 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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT00974974
GET https://conductscience.org/api/trials/v1/NCT00974974/events?page=2