Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
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| ClinicalTrials.gov Identifier: NCT00489255 |
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Recruitment Status :
Completed
First Posted : June 21, 2007
Results First Posted : May 20, 2013
Last Update Posted : January 30, 2019
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Sponsor:
Ipsen
Collaborator:
INC Research Limited
Information provided by (Responsible Party):
Ipsen
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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®
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease | Drug: Tigan® Drug: Placebo | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 117 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo |
| Study Start Date : | May 2007 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | March 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Parkinson disease
| Arm | Intervention/treatment |
|---|---|
| Experimental: Trimethobenzamide (Tigan®) |
Drug: Tigan®
Oral capsule, 300mg three times daily |
| Placebo Comparator: Inactive substance |
Drug: Placebo
Oral capsule, three times daily |
Primary Outcome Measures :
- 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) ]
Secondary Outcome Measures :
- Incidence of Nausea and/or Vomiting for Period 1 [ Time Frame: Days 1-28 ]
- Incidence of Nausea and/or Vomiting for Period 2 [ Time Frame: Days 29-56 ]
- Incidence of Nausea and/or Vomiting for Period 3 [ Time Frame: Days 57-84 ]
- Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 3/End of Period 1 Injection [ Time Frame: 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.
- Median Time to 'on' for Visit 4/End of Period 2 Injection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489255
Locations
Show 27 study locations
Sponsors and Collaborators
Ipsen
INC Research Limited
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00489255 |
| Other Study ID Numbers: |
Y-47-52844-003 APO-4PD-01 |
| First Posted: | June 21, 2007 Key Record Dates |
| Results First Posted: | May 20, 2013 |
| Last Update Posted: | January 30, 2019 |
| Last Verified: | January 2019 |
Keywords provided by Ipsen:
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Parkinson's disease Anti-emetic Nausea Vomiting |
Additional relevant MeSH terms:
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Parkinson Disease Nausea Vomiting Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Signs and Symptoms, Digestive |