Parkinson's DiseaseFipamezoleNCT01140841
A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa
An observational study of Parkinson's Disease, run by Bausch Health Americas, Inc. at 4 sites in United States.
Trial summary
The purpose of this clinical trial is to determine the maximum tolerated dose of Fipamezole in adult patients with Parkinson's disease who are receiving levodopa. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Fipamezole ODT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2010to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's Disease on stable regimen of levodopa
Who may be able to join
- Subject is a man or woman between 30 and 75 years of age, inclusive, with intact oral mucosa at Screening (Visit 1) and Randomization (Visit 2).
- Subject has a diagnosis of idiopathic Parkinson's disease defined according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria.
- Subject has been receiving a stable regimen of at least three daily administrations of levodopa (with a peripheral dopa decarboxylase inhibitor), with no dose changes for at least 4 weeks prior to Randomization (Visit 2).
- Subject is rated at stage 2 to 4 on the Hoehn and Yahr scale.
- If currently taking other medications (other than levodopa), subject must be on a stable regimen, defined as no dose changes for at least 1 month prior to Randomization (Visit 2).
- Subject demonstrates the ability to comprehend the study procedures and provide informed consent.
- Female subjects must be either postmenopausal for at least 1 year or surgically sterilized at least 3 months prior to Randomization (Visit 2). Male subjects must either be sterile or willing to use 2 approved methods of contraception when engaged in sexual intercourse with a female partner from Randomization (Visit 2) until 30 days after the last dose of study drug.
- Subject has an upper arm circumference of not less than 24 cm and not more than 42 cm for both arms.
Who cannot join
- Subject participated in an investigational medication study within the 3 months prior to Randomization (Visit 2).
- Subject has immediate family members who are site Investigators or sponsor employees.
- Subject has a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Subject has impaired renal function (defined as a creatinine level of ≥ 1.5 times the upper limit of normal) at Screening (Visit 1).
- Subject has impaired hepatic function (defined as SGOT/AST or SGPT/ALT levels ≥ 1.5 times the upper limit of normal) at Screening (Visit 1).
- Subject has second- or third-degree atrioventricular block or sick sinus syndrome, atrial fibrillation, atrial flutter, severe or unstable angina, congestive heart failure, or myocardial infarction within 3 months of the screening visit or a significant ECG abnormality, including a QRS > 110 msec, a PR interval > 230 msec, a QTc ≥ 450 msec for male subjects, or a QTc ≥ 470 msec for female subjects.
Show all 14Show fewer
- Subject has a history of risk factors for Torsades de Pointes, including unexplained syncope, known long QT syndrome, or a clinically significant abnormal laboratory assessment such as hypokalemia, hypercalcemia, or hypomagnesemia. Subjects with a family history of long QT syndrome or Brugada syndrome will also be excluded.
- Subject is at immediate risk of requiring hospitalization.
- Subject has significant tremor or dyskinesia which, in the opinion of the Investigator, might interfere with reliable assessment of continuous Holter ECG and ABPM.
- Subject has, in the opinion of the Investigator, a clinically important abnormality on his/her physical examination, electrocardiography, vital sign measurements, or laboratory assessment.
- Subject is being treated with a disallowed medication that cannot be discontinued prior to Randomization (Visit 2) (See Table 6).
- Subject has a current diagnosis of substance abuse or history of alcohol or drug abuse in the past 2 years prior to Screening (Visit 1).
- Subject has positive findings on urine drug screen at Screening (Visit 1).
- Subject has an allergy to fipamezole or its excipients.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Quest Research Institute
Bingham Farms, Michigan, 48025
Duke University Medical Center
Durham, North Carolina, 27705
CNS Network, Inc.
Torrance, California, 90502
Clinical Research Integrity Worldwide LLC
Willingboro, New Jersey, 08046
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose-Escalation Study of Safety and Tolerability of Oromucosal Fipamezole ODT in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa
The purpose of this clinical trial is to determine the maximum tolerated dose of Fipamezole in adult patients with Parkinson's disease who are receiving levodopa.
Read the detailed description
Parkinson's Disease is the second most common neurodegenerative disorder worldwide. While treatment with dopaminergic agents like levodopa, the mainstay of treatment, is effective in the early phases of the disease, their benefits decrease with disease progression, and problems such as dyskinesia and on-off phenomenon begin to manifest. In this study, fipamezole, a new antagonist of an adrenergic receptor, is being investigated to better understand the safety and side-effect profile in patients with Parkinson's Disease.
The sampling method used was simple random sampling.
- Conditions
- Parkinson's Disease
- Being tested
- Fipamezole ODT, Placebo
- Keywords
- Dyskinesia
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fipamezole ODTDrug
Subjects take three daily doses of Fipamezole ODT, with each dose escalating from 30 to 60, 90, 120, 150 and up to 180 mg over 8 weeks.
PlaceboDrug
1 to 2 tablets three times per day to be taken according to the same schedule as the active study drug.
| Study group | Role | What they receive |
|---|---|---|
| Fipamezole ODT | Not described Receives: Drug: Fipamezole ODT | |
| Placebo | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Maximum Tolerated Dose (MTD) of Fipamezole orally disintegrating tablets (ODT) in adult patients with Parkinson's disease.
Measured: Days -28 to 56
Secondary outcomes (3)
To assess cardiovascular safety of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease.
Measured: Days -28 to 56
To evaluate pharmacokinetics (PK) of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease.
Measured: Days -28 to 56
To assess incidence and severity of Adverse Events
Measured: Days -28 to 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Briegs, Study director, Biovail Technologies, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140841
- Sponsor's protocol ID
- BVF-025-101
- Acronym
- Fipamezole
- Status last verified
- Aug 2011
- First submitted
- 8 Jun 2010
- Last updated
- 31 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose-Escalation Study of Safety and Tolerability of Oromucosal Fipamezole ODT in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa
- ClinicalTrials.gov ID
- NCT01140841
- Acronym / sponsor ID
- Fipamezole / BVF-025-101
- Conditions
- Parkinson's Disease
- Keywords
- Dyskinesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to determine the maximum tolerated dose of Fipamezole in adult patients with Parkinson's disease who are receiving levodopa.
Detailed description
Parkinson's Disease is the second most common neurodegenerative disorder worldwide. While treatment with dopaminergic agents like levodopa, the mainstay of treatment, is effective in the early phases of the disease, their benefits decrease with disease progression, and problems such as dyskinesia and on-off phenomenon begin to manifest. In this study, fipamezole, a new antagonist of an adrenergic receptor, is being investigated to better understand the safety and side-effect profile in patients with Parkinson's Disease.
The sampling method used was simple random sampling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fipamezole ODT | – | Drug: Fipamezole ODT |
| Placebo | – | Drug: Placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease on stable regimen of levodopa
Key inclusion criteria (8 listed)
- Subject is a man or woman between 30 and 75 years of age, inclusive, with intact oral mucosa at Screening (Visit 1) and Randomization (Visit 2).
- Subject has a diagnosis of idiopathic Parkinson's disease defined according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria.
- Subject has been receiving a stable regimen of at least three daily administrations of levodopa (with a peripheral dopa decarboxylase inhibitor), with no dose changes for at least 4 weeks prior to Randomization (Visit 2).
- Subject is rated at stage 2 to 4 on the Hoehn and Yahr scale.
- If currently taking other medications (other than levodopa), subject must be on a stable regimen, defined as no dose changes for at least 1 month prior to Randomization (Visit 2).
Key exclusion criteria (14 listed)
- Subject participated in an investigational medication study within the 3 months prior to Randomization (Visit 2).
- Subject has immediate family members who are site Investigators or sponsor employees.
- Subject has a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Subject has impaired renal function (defined as a creatinine level of ≥ 1.5 times the upper limit of normal) at Screening (Visit 1).
- Subject has impaired hepatic function (defined as SGOT/AST or SGPT/ALT levels ≥ 1.5 times the upper limit of normal) at Screening (Visit 1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fipamezole ODTSubjects take three daily doses of Fipamezole ODT, with each dose escalating from 30 to 60, 90, 120, 150 and up to 180 mg over 8 weeks. | Drug | Fipamezole ODT |
| Placebo1 to 2 tablets three times per day to be taken according to the same schedule as the active study drug. | Drug | Placebo |
Primary outcome
To determine the Maximum Tolerated Dose (MTD) of Fipamezole orally disintegrating tablets (ODT) in adult patients with Parkinson's disease.
Time frame: Days -28 to 56
3 secondary outcomes
To assess cardiovascular safety of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease.
Time frame: Days -28 to 56
To evaluate pharmacokinetics (PK) of ascending doses of Fipamezole ODT in adult patients with Parkinson's disease.
Time frame: Days -28 to 56
To assess incidence and severity of Adverse Events
Time frame: Days -28 to 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Briegs study director
Biovail Technologies, Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Bausch Health Americas, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Maximum Tolerated Dose (MTD) of Fipamezole orally disintegrating tablets (ODT) in adult patients with Parkinson's disease. (time frame: Days -28 to 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2011.