Trial Outcomes & Findings for Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) (NCT NCT01770145)
NCT ID: NCT01770145
Last Updated: 2023-08-14
Results Overview
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".
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
127 participants
Primary outcome timeframe
L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
APOKYN
Subjects will complete an L-Dopa Baseline Period in which they record daily "time to on" following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record "time to on" following the APOKYN injection.
|
|---|---|
|
Baseline
STARTED
|
127
|
|
Baseline
COMPLETED
|
101
|
|
Baseline
NOT COMPLETED
|
26
|
|
Treatment
STARTED
|
101
|
|
Treatment
COMPLETED
|
97
|
|
Treatment
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
APOKYN
Subjects will complete an L-Dopa Baseline Period in which they record daily "time to on" following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record "time to on" following the APOKYN injection.
|
|---|---|
|
Baseline
Adverse Event
|
20
|
|
Baseline
Withdrawal by Subject
|
1
|
|
Baseline
Lost to Follow-up
|
1
|
|
Baseline
Unable to define optimal dose
|
4
|
|
Treatment
Adverse Event
|
3
|
|
Treatment
Withdrawal by Subject
|
1
|
Baseline Characteristics
Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)
Baseline characteristics by cohort
| Measure |
APOKYN
n=127 Participants
Subjects will complete an L-Dopa Baseline Period in which they record daily "time to on" following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record "time to on" following the APOKYN injection.
|
|---|---|
|
Age, Continuous
|
65.20 years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
121 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 participants
n=5 Participants
|
|
Duration of Parkinson's Disease (years)
0-5 years
|
21 participants
n=5 Participants
|
|
Duration of Parkinson's Disease (years)
6-10 years
|
48 participants
n=5 Participants
|
|
Duration of Parkinson's Disease (years)
11-15 years
|
34 participants
n=5 Participants
|
|
Duration of Parkinson's Disease (years)
15+ years
|
24 participants
n=5 Participants
|
|
Duration of Akinesia (years)
<2 years
|
44 participants
n=5 Participants
|
|
Duration of Akinesia (years)
2-4 years
|
35 participants
n=5 Participants
|
|
Duration of Akinesia (years)
5-6 years
|
16 participants
n=5 Participants
|
|
Duration of Akinesia (years)
>6 years
|
28 participants
n=5 Participants
|
|
Duration of Akinesia (years)
Unknown
|
4 participants
n=5 Participants
|
|
Average Daily Time to On
|
59.13 minutes
STANDARD_DEVIATION 18.13 • n=5 Participants
|
PRIMARY outcome
Timeframe: L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7Patients 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".
Outcome measures
| Measure |
APOKYN
n=88 Participants
In the study, subjects will complete an L-Dopa Baseline Period in which they record daily "time to on" following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record "time to on" following the APOKYN injection.
|
|---|---|
|
Change From Baseline in Average Daily "Time to on" ("TTO") by Subject Diary.
Baseline
|
60.86 minutes
Standard Deviation 18.11
|
|
Change From Baseline in Average Daily "Time to on" ("TTO") by Subject Diary.
Treatment Period
|
23.72 minutes
Standard Deviation 14.55
|
|
Change From Baseline in Average Daily "Time to on" ("TTO") by Subject Diary.
Change from Baseline
|
37.14 minutes
Standard Deviation 20.51
|
SECONDARY outcome
Timeframe: L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-8Population: 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)
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.
Outcome measures
Outcome data not reported
Adverse Events
APOKYN
Serious events: 0 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
APOKYN
n=127 participants at risk
In the study, subjects will complete an L-Dopa Baseline Period in which they record daily "time to on" following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record "time to on" following the APOKYN injection.
|
|---|---|
|
General disorders
Chills
|
4.7%
6/127 • Number of events 6
|
|
General disorders
Chest Pain
|
0.79%
1/127 • Number of events 1
|
|
General disorders
Chest Discomfort
|
1.6%
2/127 • Number of events 2
|
|
General disorders
Vomiting
|
4.7%
6/127 • Number of events 6
|
|
Gastrointestinal disorders
Toothache
|
0.79%
1/127 • Number of events 1
|
|
Gastrointestinal disorders
Salivary hyper-secretion
|
0.79%
1/127 • Number of events 1
|
|
Gastrointestinal disorders
Retching
|
0.79%
1/127 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
19.7%
25/127 • Number of events 25
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/127
|
|
Eye disorders
Vision blurred
|
0.79%
1/127 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.79%
1/127 • Number of events 1
|
|
Eye disorders
Eyelid ptosis
|
0.79%
1/127 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.79%
1/127 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.79%
1/127 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.79%
1/127 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.79%
1/127 • Number of events 1
|
|
Ear and labyrinth disorders
Ear Pain
|
0.79%
1/127 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.79%
1/127 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
0.00%
0/127
|
|
Injury, poisoning and procedural complications
Stress Fracture
|
0.79%
1/127 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/127
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.79%
1/127 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.79%
1/127 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/127
|
|
Injury, poisoning and procedural complications
Contusion
|
0.79%
1/127 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
1.6%
2/127 • Number of events 2
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/127
|
|
Infections and infestations
Rhinitis
|
0.79%
1/127 • Number of events 1
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/127
|
|
Infections and infestations
Cellulitis
|
0.00%
0/127
|
|
General disorders
Oedema
|
1.6%
2/127 • Number of events 2
|
|
General disorders
Injection Site Pruritus
|
0.79%
1/127 • Number of events 1
|
|
General disorders
Injection site erythema
|
0.79%
1/127 • Number of events 1
|
|
General disorders
Injection site bruising
|
0.00%
0/127
|
|
General disorders
Feeling hot
|
1.6%
2/127 • Number of events 2
|
|
General disorders
Fatigue
|
1.6%
2/127 • Number of events 2
|
|
Psychiatric disorders
Confusional state
|
0.79%
1/127 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/127
|
|
Nervous system disorders
Syncope
|
0.00%
0/127
|
|
Nervous system disorders
Somnolence
|
5.5%
7/127 • Number of events 7
|
|
Nervous system disorders
Paraesthesia
|
0.79%
1/127 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/127
|
|
Nervous system disorders
Hyposaethesia
|
0.79%
1/127 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.6%
2/127 • Number of events 2
|
|
Nervous system disorders
Dyskinesia
|
0.79%
1/127 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.79%
1/127 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.79%
1/127 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/127
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.79%
1/127 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.79%
1/127 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.79%
1/127 • Number of events 1
|
|
Investigations
Heart rate increased
|
0.79%
1/127 • Number of events 1
|
|
Vascular disorders
Pallor
|
2.4%
3/127 • Number of events 3
|
|
Vascular disorders
Orthostatic hypotension
|
0.79%
1/127 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.6%
2/127 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.00%
0/127
|
|
Vascular disorders
Hot flush
|
0.79%
1/127 • Number of events 1
|
|
Vascular disorders
Flushing
|
3.1%
4/127 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.4%
3/127 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.79%
1/127 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.79%
1/127 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
7.9%
10/127 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Sneezing
|
0.79%
1/127 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.79%
1/127 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.79%
1/127 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.79%
1/127 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.79%
1/127 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.79%
1/127 • Number of events 1
|
|
Psychiatric disorders
Restlessness
|
0.79%
1/127 • Number of events 1
|
|
Psychiatric disorders
Delusion
|
0.79%
1/127 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor shall have the first right, within nine months following the Sponsor having in its possession all data related to the Study, to publish the Study lead paper. Following the foregoing, the Institution shall have the right, consistent with academic standards, to publish the results of Study provided the Institution provides a publications committee, comprised of at least the Sponsor, with a draft at least thirty (30) days prior to planned submission.
- Publication restrictions are in place
Restriction type: OTHER