Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00489255
• Date of registration: 20/06/2007
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
• Scientific 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
• Date of first enrolment: May 2007
• Target sample size: 117
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00489255
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: Tigan®

Primary Outcome(s)

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(s)

Median Time to 'on' for Visit 4/End of Period 2 Injection [Time Frame: Day 56 (Visit 4)]

Subject Global Evaluation of Randomized Study Medication for Period 1 [Time Frame: Day 28 (Visit 3)]

Subject Global Evaluation of Randomized Study Medication for Period 3 [Time Frame: Day 84 (Visit 5)]

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)]

Incidence of Nausea and/or Vomiting for Period 1 [Time Frame: Days 1-28]

Median Time to 'on' for Visit 2/Period 1 Injection 2 [Time Frame: Day 1 (Visit 2)]

Median Time to 'on' for Visit 2/Period 1 Injection 1 [Time Frame: Day 1 (Visit 2)]

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)]

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1 [Time Frame: Day 28]

Median Time to 'on' for Visit 5/End of Period 3 Injection [Time Frame: Day 84 (Visit 5)]

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 3 [Time Frame: Days 57-84]

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)]

Median Time to 'on' for Visit 3/End of Period 1 Injection [Time Frame: Day 28]

Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1 [Time Frame: Days 1-28]

Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1 [Time Frame: Day 28]

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)]

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)]

Incidence of Nausea and/or Vomiting for Period 2 [Time Frame: Days 29-56]

Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2 [Time Frame: Days 29-56]

Subject Global Evaluation of Randomized Study Medication for Period 2 [Time Frame: Day 56 (Visit 4)]

Secondary ID(s)

APO-4PD-01

Y-47-52844-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

INC Research Limited

Results

• Results available: Yes
• Date Posted: 20/05/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00489255