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| ID | Type | Description | Link |
|---|---|---|---|
| APO-4PD-01 |
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| Name | Class |
|---|---|
| INC Research Limited | INDUSTRY |
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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®
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trimethobenzamide (Tigan®) | Experimental |
| |
| Inactive substance | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tigan® | Drug | Oral capsule, 300mg three times daily |
| |
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nausea and/or Vomiting for Period 1 | Days 1-28 | |
| Incidence of Nausea and/or Vomiting for Period 2 | Days 29-56 | |
| Incidence of Nausea and/or Vomiting for Period 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Movement Disorder Clinic | Phoenix | Arizona | 85013 | United States | ||
| Mayo Clinic |
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.
Patients were recruited at 24 investigational sites in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Trimethobenzamide (Tigan®) | Tigan® : Oral capsule, 300mg three times daily. |
| FG001 | Tigan:Placebo | Placebo : Oral capsule, three times daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening and Initial Randomization |
|
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| Placebo |
| Drug |
Oral capsule, three times daily |
|
| Days 57-84 |
| 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. | Days 1-28 |
| 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. | Days 29-56 |
| 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. | Days 57-84 |
| 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. | Day 28 (Visit 3) |
| 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. | Day 56 (Visit 4) |
| 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. | Day 84 (Visit 5) |
| 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. | Day 1 (Visit 2) |
| 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. | Day 1 (Visit 2) |
| 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. | Day 28 |
| 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. | Day 56 (Visit 4) |
| 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. | Day 84 (Visit 5) |
| 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. | Day 1 (Visit 2) |
| 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. | Day 28 |
| 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. | Day 28 |
| 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. | Day 56 (Visit 4) |
| 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. | Day 56 (Visit 4) |
| 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. | Day 84 (Visit 5) |
| 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. | Day 56 (Visit 4) |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Coastal Neurological Medical Group Inc. | La Jolla | California | 78258 | United States |
| Neurosearch, Inc. | Reseda | California | 91335 | United States |
| Neurosearch II, Inc. | Ventura | California | 93003 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Neurology at Shands Medical Center | Gainesville | Florida | 32608 | United States |
| University of Florida at Jacksonville | Jacksonville | Florida | 32209 | United States |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | United States |
| Charlotte Neurological Services | Port Charlotte | Florida | 33952 | United States |
| Suncoast Neuroscience Associates, Inc. | St. Petersburg | Florida | 33701 | United States |
| USF Parkinson's Disease and Movement Disorders Center of Excellence | Tampa | Florida | 33606 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| NorthShore University Health System | Glenview | Illinois | 60026 | United States |
| Iowa Health Physicians | Des Moines | Iowa | 50309 | United States |
| Parkinson's & Movements Disorders Center of Maryland | Elkridge | Maryland | 21075 | United States |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | United States |
| Henry Ford Health System - Franklin Point | Southfield | Michigan | 48034 | United States |
| Parkinson's Disease and Movement Disorders Center of Long Island | Commack | New York | 11725 | United States |
| Kingston Neurological Associates | Kingston | New York | 12401 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| Neurological Institute, Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Neurology Specialist of Dallas P.A | Dallas | Texas | 75231 | United States |
| Parkinson's Disease and Movement Disorders Center, Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Neurology Associates, P.A. | San Antonio | Texas | 78258 | United States |
| East Texas Medical Center | Tyler | Texas | 75701 | United States |
| Sentara Neurological Associates | Virginia Beach | Virginia | 23456 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 1: Days 1 to 28 |
|
|
| Period 2: Days 29 to 56 |
|
|
| Period 3: Days 57 to 84 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trimethobenzamide (Tigan®) | Tigan® : Oral capsule, 300mg three times daily. |
| BG001 | Placebo | Placebo : Oral capsule, three times daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Period 1: Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 134. Overall Number of Baseline Participants in 'Placebo' arm is 46. | Median | Full Range | years |
| ||||||||||||||
| Age, Continuous | Period 2 (Re-randomized patients): Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 64. Overall Number of Baseline Participants in 'Placebo' arm is 30 (re-randomized) and 59 (all placebo). | Median | Full Range | years |
| ||||||||||||||
| Age, Continuous | Period 3 (Re-randomized patients): Overall Number of Baseline Participants in 'Trimethobenzamide (Tigan®)' arm is 28. Overall Number of Baseline Participants in 'Placebo' arm is is 30 (re-randomized) and 82 (all placebo). | Median | Full Range | years |
| ||||||||||||||
| Sex: Female, Male | Data for Period 1. Period 2 & 3 are as follows: Period 2, Re-randomized patients Female: 19 participants in 'Trimethobenzamide (Tigan®)' arm and 11 participants in 'Placebo' arm. Male: 45 participants in 'Trimethobenzamide (Tigan®)' arm and 19 participants in 'Placebo' arm. Period 3, Re-randomized patients Female: 7 participants in 'Trimethobenzamide (Tigan®)' arm and 8 participants in 'Placebo' arm. Male: 21 participants in 'Trimethobenzamide (Tigan®)' arm and 22 participants in 'Placebo' arm. | Count of Participants | Participants |
| |||||||||||||||
| Unified Parkinson's Disease Rating Scale (UPDRS) total score for Period 1 | The UPDRS is a 4-part rating tool to follow the longitudinal course of Parkinson's disease. The four sections in the scale are 1. Mentation, Behavior and Mood, 2. Activities of Daily Living (ADL), 3. Motor Exam and 4. Complications of Therapy. UPDRS total score range from 0 to 199, with 199 indicative of the worst and 0 no disability. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| UPDRS motor score for Period 1 | Part III (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. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| UPDRS total score for Period 2 | The UPDRS is a 4-part rating tool to follow the longitudinal course of Parkinson's disease. The four sections in the scale are 1. Mentation, Behavior and Mood, 2. Activities of Daily Living (ADL), 3. Motor Exam and 4. Complications of Therapy. UPDRS total score range from 0 to 199, with 199 indicative of the worst and 0 no disability. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| UPDRS motor score for Period 2 | Part III (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. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| UPDRS total score for Period 3 | The UPDRS is a 4-part rating tool to follow the longitudinal course of Parkinson's disease. The four sections in the scale are 1. Mentation, Behavior and Mood, 2. Activities of Daily Living (ADL), 3. Motor Exam and 4. Complications of Therapy. UPDRS total score range from 0 to 199, with 199 indicative of the worst and 0 no disability. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| UPDRS motor score for Period 3 | Part III (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. | Mean | Standard Deviation | Score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 | Primary efficacy analyses performed on the Intention-to-Treat (ITT) population. | Posted | Number | participants | Day 1 (Period 1, Visit 2) |
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| Secondary | Incidence of Nausea and/or Vomiting for Period 1 | Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population. | Posted | Number | participants | Days 1-28 |
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| Secondary | Incidence of Nausea and/or Vomiting for Period 2 | Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population. | Posted | Number | participants | Days 29-56 |
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| Secondary | Incidence of Nausea and/or Vomiting for Period 3 | Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population. | Posted | Number | participants | Days 57-84 |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Days 1-28 |
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| 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. | Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Days 29-56 |
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| 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. | Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Days 57-84 |
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| 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. | This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population. | Posted | Number | participants | Day 28 (Visit 3) |
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| 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. | This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population. | Posted | Number | participants | Day 56 (Visit 4) |
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| 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. | This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population. | Posted | Number | participants | Day 84 (Visit 5) |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | minutes | Day 1 (Visit 2) |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | minutes | Day 1 (Visit 2) |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | minutes | Day 28 |
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| 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. | Posted | Median | 95% Confidence Interval | minutes | Day 56 (Visit 4) |
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| 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. | Posted | Median | 95% Confidence Interval | minutes | Day 84 (Visit 5) |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (Visit 2) |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Day 28 |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Day 28 |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Day 56 (Visit 4) |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Day 56 (Visit 4) |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Day 84 (Visit 5) |
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| 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. | This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population. | Posted | Mean | Standard Deviation | score on a scale | Day 56 (Visit 4) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trimethobenzamide (Tigan®) | Tigan® : Oral capsule, 300mg three times daily. | 4 | 134 | 86 | 134 | ||
| EG001 | Placebo | Placebo : Oral capsule, three times daily. | 6 | 106 | 57 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Back injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Hyperhydrosis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Neurology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100146 | trimethobenzamide |
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| Physician Decision |
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| Noncompliance |
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| Lost to Follow-up |
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| Male |
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