Phase 4
Completed N=194
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
Source: ClinicalTrials.gov NCT00489255 ↗Enrolled (actual)
194
Serious AEs
4.2%
Results posted
May 2013
Primary outcomePrimary: Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 — 21; 10; 109; 34 participants — p=0.09
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®
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 |
21; 10; 109; 34 | 0.09 |
| SECONDARY Incidence of Nausea and/or Vomiting for Period 1 |
48; 24; 82; 20 | 0.025 sig |
| SECONDARY Incidence of Nausea and/or Vomiting for Period 2 |
15; 14; 48; 16 | 0.005 sig |
| SECONDARY Incidence of Nausea and/or Vomiting for Period 3 |
9; 10; 18; 20 | 0.65 |
| SECONDARY Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1 |
0.51; 0.80 | 0.32 |
| SECONDARY Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2 |
0.19; 1.27 | 0.001 sig |
| SECONDARY Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3 |
0.27; 0.21 | 0.95 |
| SECONDARY Subject Global Evaluation of Randomized Study Medication for Period 1 |
61; 20; 23; 5; 10; 3 | 0.88 |
| SECONDARY Subject Global Evaluation of Randomized Study Medication for Period 2 |
38; 15; 16; 4; 2; 2 | 0.019 sig |
| SECONDARY Subject Global Evaluation of Randomized Study Medication for Period 3 |
17; 24; 4; 2; 3; 0 | 0.29 |
| SECONDARY Median Time to 'on' for Visit 2/Period 1 Injection 1 |
25.0; 20.0 | 0.17 |
| SECONDARY Median Time to 'on' for Visit 2/Period 1 Injection 2 |
20.0; 16.5 | 0.008 sig |
| SECONDARY Median Time to 'on' for Visit 3/End of Period 1 Injection |
12.0; 10.0 | 0.49 |
| SECONDARY Median Time to 'on' for Visit 4/End of Period 2 Injection |
10.0; 12.0 | 0.4 |
| SECONDARY Median Time to 'on' for Visit 5/End of Period 3 Injection |
10.0; 10.0 | 0.62 |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1 |
35.5; 35.3 | 0.96 |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1 |
34.0; 34.2 | 0.93 |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1 |
20.8; 21.1 | 0.84 |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2 |
37.1; 33.3 | 0.25 |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2 |
20.9; 19.0 | 0.46 |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3 |
37.7; 34.3 | 0.33 |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3 |
22.6; 21.4 | 0.93 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00489255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.