Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Anti-emetic, Nausea, Vomiting
Brief summary
The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
Detailed description
Initial randomization is Tigan or Placebo (3:1) with phased withdrawal of Tigan to Placebo after 4 and 8 weeks. Subjects completing 4 weeks Tigan re-randomized to Tigan or Placebo (2:1) with patients completing 8 weeks Tigan re-randomized to receive Tigan or Placebo (1:1). Subjects randomized to Placebo over the previous 4 weeks assigned to continue on Placebo for the remainder of the study.
Interventions
DRUGTigan®
Oral capsule, 300mg three times daily
DRUGPlacebo
Oral capsule, three times daily
Sponsors
INC Research Limited
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged 18 years or over * Subjects with advanced Parkinson's disease with disabling hypomobility (off episodes) who are to be initiated with Apokyn® by intermittent subcutaneous injection * Able to swallow Tigan®/placebo capsules * Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures * Women of child bearing potential must have a negative serum pregnancy test (beta hCG) prior to receiving study drug and must be using an appropriate form of contraception * Willing and able to provide informed consent
Exclusion criteria
* Hypersensitive to apomorphine hydrochloride or any of the ingredients of Apokyn® (notably sodium metabisulfite) * Hypersensitive to trimethobenzamide or any of the ingredients of Tigan® * Previous treatment with Apokyn® * Participation in any other clinical trial within 14 days of the present trial * Contraindications to Apokyn® or Tigan® * Currently taking, or likely to need to take at any time during the course of the study, any 5HT3 antagonist (ondansetron, alosetron, granisetron, palonosetron or dolasetron) * Malignant melanoma or a history of previously treated malignant melanoma * Pregnancy or breast feeding * Receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial * Any significant medical disorder, condition, concomitant medication or psychiatric disorder according to DSM-IV criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 | Day 1 (Period 1, Visit 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Nausea and/or Vomiting for Period 2 | Days 29-56 | — |
| Incidence of Nausea and/or Vomiting for Period 3 | Days 57-84 | — |
| Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1 | Days 1-28 | The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom. |
| Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2 | Days 29-56 | The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom. |
| Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3 | Days 57-84 | The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom. |
| Subject Global Evaluation of Randomized Study Medication for Period 1 | Day 28 (Visit 3) | The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor. |
| Subject Global Evaluation of Randomized Study Medication for Period 2 | Day 56 (Visit 4) | The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor. |
| Subject Global Evaluation of Randomized Study Medication for Period 3 | Day 84 (Visit 5) | The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor. |
| Median Time to 'on' for Visit 2/Period 1 Injection 1 | Day 1 (Visit 2) | Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection. |
| Median Time to 'on' for Visit 2/Period 1 Injection 2 | Day 1 (Visit 2) | Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection. |
| Incidence of Nausea and/or Vomiting for Period 1 | Days 1-28 | — |
| Median Time to 'on' for Visit 4/End of Period 2 Injection | Day 56 (Visit 4) | Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection. |
| Median Time to 'on' for Visit 5/End of Period 3 Injection | Day 84 (Visit 5) | Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1 | Day 1 (Visit 2) | Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1 | Day 28 | Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1 | Day 28 | Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2 | Day 56 (Visit 4) | Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2 | Day 56 (Visit 4) | Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3 | Day 84 (Visit 5) | Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3 | Day 56 (Visit 4) | Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability. |
| Median Time to 'on' for Visit 3/End of Period 1 Injection | Day 28 | Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited at 24 investigational sites in the United States (US).
Pre-assignment details
Number of participants STARTED does not match Enrollment, Actual (in protocol section) due to re-randomization design of the study & phased withdrawal of subjects from Tigan to placebo. Some subjects were included on one treatment in one period and re-randomized to a different treatment in a later period.
Participants by arm
| Arm | Count |
|---|---|
| Trimethobenzamide (Tigan®) Tigan® : Oral capsule, 300mg three times daily. | 134 |
| Placebo Placebo : Oral capsule, three times daily. | 46 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: Days 1 to 28 | Adverse Event | 21 | 8 |
| Period 1: Days 1 to 28 | Noncompliance | 2 | 0 |
| Period 1: Days 1 to 28 | Physician Decision | 1 | 4 |
| Period 1: Days 1 to 28 | Withdrawal by Subject | 5 | 0 |
| Period 2: Days 29 to 56 | Adverse Event | 3 | 1 |
| Period 2: Days 29 to 56 | Withdrawal by Subject | 0 | 3 |
| Period 3: Days 57 to 84 | Adverse Event | 3 | 3 |
| Period 3: Days 57 to 84 | Lost to Follow-up | 0 | 1 |
| Period 3: Days 57 to 84 | Withdrawal by Subject | 1 | 0 |
| Screening and Initial Randomization | Discontinued prior to taking study drug | 9 | 3 |
Baseline characteristics
| Characteristic | Placebo | Trimethobenzamide (Tigan®) | Total |
|---|---|---|---|
| Age, Continuous | 63.0 years | 66.5 years | 64.0 years |
| Sex: Female, Male Female | 13 Participants | 42 Participants | 55 Participants |
| Sex: Female, Male Male | 33 Participants | 92 Participants | 125 Participants |
| Unified Parkinson's Disease Rating Scale (UPDRS) total score for Period 1 | 47.8 Score on a scale STANDARD_DEVIATION 17.83 | 49.2 Score on a scale STANDARD_DEVIATION 21.26 | 48.8 Score on a scale STANDARD_DEVIATION 20.4 |
| UPDRS motor score for Period 1 | 25.2 Score on a scale STANDARD_DEVIATION 12.25 | 25.7 Score on a scale STANDARD_DEVIATION 15.07 | 25.6 Score on a scale STANDARD_DEVIATION 14.37 |
| UPDRS motor score for Period 2 | 25.5 Score on a scale STANDARD_DEVIATION 12.6 | 24.3 Score on a scale STANDARD_DEVIATION 15.5 | 24.9 Score on a scale STANDARD_DEVIATION 14.14 |
| UPDRS motor score for Period 3 | 25.1 Score on a scale STANDARD_DEVIATION 14.69 | 25.5 Score on a scale STANDARD_DEVIATION 13.58 | 25.2 Score on a scale STANDARD_DEVIATION 14.35 |
| UPDRS total score for Period 2 | 47.6 Score on a scale STANDARD_DEVIATION 18.83 | 46.7 Score on a scale STANDARD_DEVIATION 21.32 | 47.1 Score on a scale STANDARD_DEVIATION 20.09 |
| UPDRS total score for Period 3 | 47.5 Score on a scale STANDARD_DEVIATION 20.87 | 48.1 Score on a scale STANDARD_DEVIATION 17.84 | 47.6 Score on a scale STANDARD_DEVIATION 20.06 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 86 / 134 | 57 / 106 |
| serious Total, serious adverse events | 4 / 134 | 6 / 106 |
Outcome results
Primary
Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1
Time frame: Day 1 (Period 1, Visit 2)
Population: Primary efficacy analyses performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 | Subjects who experienced nausea &/or vomiting[Yes] | 21 participants |
| Trimethobenzamide (Tigan®) | Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 | Subjects who experienced nausea &/or vomiting [No] | 109 participants |
| Placebo | Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 | Subjects who experienced nausea &/or vomiting[Yes] | 10 participants |
| Placebo | Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 | Subjects who experienced nausea &/or vomiting [No] | 34 participants |
Comparison: The null hypothesis was no difference between treatments.p-value: 0.0995% CI: [0.17, 1.11]Cochran-Mantel-Haenszel
Secondary
Incidence of Nausea and/or Vomiting for Period 1
Time frame: Days 1-28
Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Incidence of Nausea and/or Vomiting for Period 1 | Yes | 48 participants |
| Trimethobenzamide (Tigan®) | Incidence of Nausea and/or Vomiting for Period 1 | No | 82 participants |
| Placebo | Incidence of Nausea and/or Vomiting for Period 1 | Yes | 24 participants |
| Placebo | Incidence of Nausea and/or Vomiting for Period 1 | No | 20 participants |
p-value: 0.02595% CI: [0.21, 0.9]Cochran-Mantel-Haenszel
Secondary
Incidence of Nausea and/or Vomiting for Period 2
Time frame: Days 29-56
Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Incidence of Nausea and/or Vomiting for Period 2 | Yes | 15 participants |
| Trimethobenzamide (Tigan®) | Incidence of Nausea and/or Vomiting for Period 2 | No | 48 participants |
| Placebo | Incidence of Nausea and/or Vomiting for Period 2 | Yes | 14 participants |
| Placebo | Incidence of Nausea and/or Vomiting for Period 2 | No | 16 participants |
p-value: 0.00595% CI: [0.09, 0.7]Cochran-Mantel-Haenszel
Secondary
Incidence of Nausea and/or Vomiting for Period 3
Time frame: Days 57-84
Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Incidence of Nausea and/or Vomiting for Period 3 | Yes | 9 participants |
| Trimethobenzamide (Tigan®) | Incidence of Nausea and/or Vomiting for Period 3 | No | 18 participants |
| Placebo | Incidence of Nausea and/or Vomiting for Period 3 | Yes | 10 participants |
| Placebo | Incidence of Nausea and/or Vomiting for Period 3 | No | 20 participants |
p-value: 0.6595% CI: [0.23, 2.48]Cochran-Mantel-Haenszel
Secondary
Median Time to 'on' for Visit 2/Period 1 Injection 1
Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection.
Time frame: Day 1 (Visit 2)
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trimethobenzamide (Tigan®) | Median Time to 'on' for Visit 2/Period 1 Injection 1 | 25.0 minutes |
| Placebo | Median Time to 'on' for Visit 2/Period 1 Injection 1 | 20.0 minutes |
p-value: 0.1795% CI: [0.5, 1.1]Regression, Cox
Secondary
Median Time to 'on' for Visit 2/Period 1 Injection 2
Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection.
Time frame: Day 1 (Visit 2)
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trimethobenzamide (Tigan®) | Median Time to 'on' for Visit 2/Period 1 Injection 2 | 20.0 minutes |
| Placebo | Median Time to 'on' for Visit 2/Period 1 Injection 2 | 16.5 minutes |
p-value: 0.00895% CI: [0.1, 0.7]Regression, Cox
Secondary
Median Time to 'on' for Visit 3/End of Period 1 Injection
Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection.
Time frame: Day 28
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trimethobenzamide (Tigan®) | Median Time to 'on' for Visit 3/End of Period 1 Injection | 12.0 minutes |
| Placebo | Median Time to 'on' for Visit 3/End of Period 1 Injection | 10.0 minutes |
p-value: 0.4995% CI: [0.6, 1.3]Regression, Cox
Secondary
Median Time to 'on' for Visit 4/End of Period 2 Injection
Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection.
Time frame: Day 56 (Visit 4)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trimethobenzamide (Tigan®) | Median Time to 'on' for Visit 4/End of Period 2 Injection | 10.0 minutes |
| Placebo | Median Time to 'on' for Visit 4/End of Period 2 Injection | 12.0 minutes |
p-value: 0.495% CI: [0.7, 2.1]Regression, Cox
Secondary
Median Time to 'on' for Visit 5/End of Period 3 Injection
Time to on (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of on and time of injection.
Time frame: Day 84 (Visit 5)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trimethobenzamide (Tigan®) | Median Time to 'on' for Visit 5/End of Period 3 Injection | 10.0 minutes |
| Placebo | Median Time to 'on' for Visit 5/End of Period 3 Injection | 10.0 minutes |
p-value: 0.6295% CI: [0.6, 2.3]Regression, Cox
Secondary
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Time frame: Days 1-28
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1 | 0.51 score on a scale | Standard Deviation 1.504 |
| Placebo | Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1 | 0.80 score on a scale | Standard Deviation 1.755 |
p-value: 0.3295% CI: [-0.64, 0.21]ANOVA
Secondary
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Time frame: Days 29-56
Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2 | 0.19 score on a scale | Standard Deviation 0.491 |
| Placebo | Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2 | 1.27 score on a scale | Standard Deviation 2.568 |
p-value: 0.00195% CI: [-1.71, -0.43]ANOVA
Secondary
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Time frame: Days 57-84
Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3 | 0.27 score on a scale | Standard Deviation 0.684 |
| Placebo | Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3 | 0.21 score on a scale | Standard Deviation 0.392 |
p-value: 0.9595% CI: [-0.2, 0.19]ANOVA
Secondary
Subject Global Evaluation of Randomized Study Medication for Period 1
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor.
Time frame: Day 28 (Visit 3)
Population: This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 1 | Very good | 23 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 1 | Fair | 6 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 1 | Good | 10 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 1 | Poor | 7 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 1 | Excellent | 61 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 1 | Poor | 3 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 1 | Excellent | 20 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 1 | Very good | 5 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 1 | Good | 3 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 1 | Fair | 3 participants |
p-value: 0.88Cochran-Mantel-Haenszel
Secondary
Subject Global Evaluation of Randomized Study Medication for Period 2
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor.
Time frame: Day 56 (Visit 4)
Population: This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 2 | Very good | 16 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 2 | Fair | 3 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 2 | Good | 2 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 2 | Poor | 2 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 2 | Excellent | 38 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 2 | Poor | 6 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 2 | Excellent | 15 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 2 | Very good | 4 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 2 | Good | 2 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 2 | Fair | 2 participants |
p-value: 0.019Cochran-Mantel-Haenszel
Secondary
Subject Global Evaluation of Randomized Study Medication for Period 3
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question Overall, how would you rate the study medication you received for nausea/vomiting? Response choices were excellent, very good, good, fair, or poor.
Time frame: Day 84 (Visit 5)
Population: This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 3 | Very good | 4 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 3 | Fair | 0 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 3 | Good | 3 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 3 | Poor | 2 participants |
| Trimethobenzamide (Tigan®) | Subject Global Evaluation of Randomized Study Medication for Period 3 | Excellent | 17 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 3 | Poor | 3 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 3 | Excellent | 24 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 3 | Very good | 2 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 3 | Good | 0 participants |
| Placebo | Subject Global Evaluation of Randomized Study Medication for Period 3 | Fair | 0 participants |
p-value: 0.29Cochran-Mantel-Haenszel
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time frame: Day 1 (Visit 2)
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1 | 35.5 score on a scale | Standard Deviation 13.72 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1 | 35.3 score on a scale | Standard Deviation 13.31 |
p-value: 0.9695% CI: [-3.59, 3.76]ANOVA
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time frame: Day 28
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1 | 20.8 score on a scale | Standard Deviation 13.21 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1 | 21.1 score on a scale | Standard Deviation 12.94 |
p-value: 0.8495% CI: [-4.12, 3.34]ANOVA
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time frame: Day 28
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1 | 34.0 score on a scale | Standard Deviation 14.27 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1 | 34.2 score on a scale | Standard Deviation 13.08 |
p-value: 0.9395% CI: [-4.37, 4.02]ANOVA
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time frame: Day 56 (Visit 4)
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2 | 20.9 score on a scale | Standard Deviation 12.86 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2 | 19.0 score on a scale | Standard Deviation 7.01 |
p-value: 0.4695% CI: [-2.47, 5.4]ANOVA
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time frame: Day 56 (Visit 4)
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2 | 37.1 score on a scale | Standard Deviation 15.07 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2 | 33.3 score on a scale | Standard Deviation 11.19 |
p-value: 0.2595% CI: [-2.17, 8.11]ANOVA
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time frame: Day 56 (Visit 4)
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3 | 22.6 score on a scale | Standard Deviation 13.52 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3 | 21.4 score on a scale | Standard Deviation 14.87 |
p-value: 0.9395% CI: [-5.57, 6.11]ANOVA
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Time frame: Day 84 (Visit 5)
Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3 | 37.7 score on a scale | Standard Deviation 13.42 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3 | 34.3 score on a scale | Standard Deviation 14.95 |
p-value: 0.3395% CI: [-3.13, 9.06]ANOVA