Trial · NCT01770145
Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)
NCT01770145, Phase 4, Completed, MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals; results first posted 2015-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT). Trials, record NCT01770145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01770145
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)
- NCT number
- NCT01770145
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 127 participants, actual
- Lead sponsor
- MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
- Conditions
- Parkinson's Disease, Motor Symptoms, Akinesia, Hypomobility, Delayed Levodopa Onset
- Interventions
- APOKYN, L-dopa, Trimethobenzamide
- First posted
- 2013-01-17
- Last updated
- 2023-08-14
- Results first posted
- 2015-09-07
- Limitations and caveats
Full analysis set (n=88) included patients who completed 5/7 days of diary entries in APOKYN treatment period. The gastroparesis sub-study to assess prevalence and severity of gastroparesis was not analyzed because too few subjects were enrolled.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Daily "Time to on" ("TTO") by Subject Diary. | L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7 | Patients will record daily "time to on" or "TTO" following their regularly scheduled first L-Dopa dose in the baseline period for 7 consecutive days. Following initiation on Apokyn therapy, patients will inject Apokyn at their regularly scheduled L-Dopa time (L-Dopa dosing will be delayed by 40 minutes following Apokyn injection) and record "time to on" or "TTO" from the injection. "Time to on" for both periods will be recorded in a standardized subject diary. Daily "TTO" for the baseline period will be averaged for each subject and compared to the daily "TTO" for the same subject during the treatment period to assess APOKYN's effect on "TTO". |
| Secondary | Change From Baseline in Gastric Emptying Time | L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-8 | A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic on 2 occasions to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period). Note, to do the second gastroparesis assessment, this sub-group of subjects had an extension for one extra day beyond the designated 7 day APOKYN treatment period (i.e., it will be 8 days) in order to keep the 7 day diary recording outpatient scope of work the same as the rest of the subjects in the study. The second inpatient period was also considered the end-of-study visit for this sub group. |
Source ClinicalTrials.gov
Outcomes2
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 Average Daily Time to on (TTO) by Subject Diary. | L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7 | minutes | MEAN | |
| SECONDARY | Change From Baseline in Gastric Emptying Time | L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-8 | A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period) |
Source ClinicalTrials.gov
Results by group3
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 Average Daily Time to on (TTO) by Subject Diary. | APOKYN | Baseline | 60.86 | Standard Deviation 18.11 | minutes |
| Change From Baseline in Average Daily Time to on (TTO) by Subject Diary. | APOKYN | Treatment Period | 23.72 | Standard Deviation 14.55 | minutes |
| Change From Baseline in Average Daily Time to on (TTO) by Subject Diary. | APOKYN | Change from Baseline | 37.14 | Standard Deviation 20.51 | minutes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline | STARTED | APOKYN | 127 | |
| Baseline | COMPLETED | APOKYN | 101 | |
| Baseline | NOT COMPLETED | APOKYN | 26 | |
| Treatment | STARTED | APOKYN | 101 | |
| Treatment | COMPLETED | APOKYN | 97 | |
| Treatment | NOT COMPLETED | APOKYN | 4 |
Source ClinicalTrials.gov
Adverse events70
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 | Chills | General disorders | APOKYN | 6 | 127 | 6 |
| other | Chest Pain | General disorders | APOKYN | 1 | 127 | 1 |
| other | Chest Discomfort | General disorders | APOKYN | 2 | 127 | 2 |
| other | Vomiting | General disorders | APOKYN | 6 | 127 | 6 |
| other | Toothache | Gastrointestinal disorders | APOKYN | 1 | 127 | 1 |
| other | Salivary hyper-secretion | Gastrointestinal disorders | APOKYN | 1 | 127 | 1 |
| other | Retching | Gastrointestinal disorders | APOKYN | 1 | 127 | 1 |
| other | Nausea | Gastrointestinal disorders | APOKYN | 25 | 127 | 25 |
| other | Diarrhea | Gastrointestinal disorders | APOKYN | 0 | 127 | 0 |
| other | Vision blurred | Eye disorders | APOKYN | 1 | 127 | 1 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APOKYN | ||
| Total, other adverse events | APOKYN | 70 | 127 |
| Total, serious adverse events | APOKYN | 0 | 127 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01770145
GET https://conductscience.org/api/trials/v1/NCT01770145/events?page=2