Parkinson's DiseasePhase 2FjordNCT00559871
Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease
A Phase 2 study testing fipamezole in people with Parkinson's Disease, run by Juvantia Pharma Ltd at 36 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether Fipamezole is effective in the treatment of levodopa-induced dyskinesia in advanced Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- fipamezole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Oct 2007to May 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Idiopathic Parkinson's disease.
- Levodopa/DDI associated peak-dose dyskinesia which is at least moderately disabling and present for ≥25% of the waking day (UPDRS part IV, items 32 and 33, each ≥ 2).
- Stable Parkinson's medication for at least 1 month prior to randomization.
- Hoehn and Yahr Stages 1 to 4 during 'Off' period.
- Demonstrated ability to comprehend and give informed consent.
- Ability to complete patient diary.
Main Exclusion Criteria:
- Other clinically significant conditions apart from those typically associated with Parkinson's disease.
- Intake of medication associated with exacerbation of dyskinesia or with extrapyramidal side effects and tardive dyskinesia or induction of liver enzymes; neuroleptics; or specified drugs known to be substantially metabolized through the following cytochrome P450 isoenzymes: 1A2, 2B6, 2C19, 2C9, 2D6, and 2E1.
- Use of St. John's Wort or Ginkgo Biloba within 48 hrs prior to randomization and until the last treatment day with the study medication.
- Intake of an investigational drug within 30 days prior to initial screening.
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States29 sites
Emory Healthcare
Atlanta, Georgia, 30329
Medical College of Georgia
Augusta, Georgia, 30912
Maryland Parkinson's Disease and Movement Disorder Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, 33486
Rush University Medical Center
Chicago, Illinois, 60612
Duke Health Center at Morreene Road
Durham, North Carolina, 27705
Colorado Neurological Institute
Englewood, Colorado, 80113
Biomedical Research Alliance of New York
Forest Hills, New York, 11375
Parkinson and Movement Disorder Institute
Fountain Valley, California, 92708
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
Sunrise Clinical Research
Hollywood, Florida, 33021
Baylor College of Medicine
Houston, Texas, 77030
University of California Irvine
Irvine, California, 92697
Parkinson Disease Center - University of Kansas Medical Center
Kansas City, Kansas, 66160
Coastal Neurological Medicine Group
La Jolla, California, 92037
Semmes Murphey Neurologic and Spine Institute
Memphis, Tennessee, 38104
Pharmax Research Clinic
Miami, Florida, 33126
University of Miami
Miami, Florida, 33136
Collier Neurological Clinic
Naples, Florida, 34102
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Neurology Clinic PC
Northport, Alabama, 35476
Oregon Health and Science University
Portland, Oregon, 97239-3098
Neurology Group of Bergen County
Ridgewood, New Jersey, 07450
Neurology Associates
San Antonio, Texas, 78258
Henry Ford Health Systems, Franklin Pointe Medical Center
Southfield, Michigan, 48034
University of South Florida, Parkinson's Disease and Movement Center
Tampa, Florida, 33606
University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5023
U Mass Memorial Medical Center
Worcester, Massachusetts, 01655-0318
India7 sites
Neurology centre
Ahmedabad, 380006
St John's Medical College & Hospital
Bangalore, 560 034
M S Ramaiah Medical College Hospital
Bangalore, 560 054
Nizam's Institute of Medical Sciences
Hyderabaad, 500 082
Chatrapati Sahuji Maharaj Medical University
Lucknow, 226003
J.S.S. Medical College and Hospital
Mysore, 570 004
Max Superspecialty Hospital
Sāket, New Delhi, 110017
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Efficacy, Safety and Tolerability of Fipamezole as an Oromucosal Fast Dissolving Tablet in the Treatment of Parkinson's Disease Patients.
The purpose of this study is to determine whether Fipamezole is effective in the treatment of levodopa-induced dyskinesia in advanced Parkinson's disease.
Read the detailed description
This study is a multi-center, double-blind, placebo-controlled, multiple dose escalating, safety, tolerance, pharmacokinetics, and efficacy study of fipamezole administered in Parkinson's disease patients who are concomitantly being treated with a combination product of levodopa with a dopamine decarboxylase inhibitor (DDI) and possible other antiparkinson medication. Approximately 30 sites in the US and India will participate in this study. The patients will be randomized into one of four treatment arms to receive either fixed or ascending doses of Fipamezole (from 30 to 90 mg tid) or placebo. For efficacy assessments, levodopa-induced dyskinesia is assessed using a standardised rating scale. Time spent in 'Off' state or in 'On' state without dyskinesia, 'On' with non-troublesome dyskinesia or 'On' with troublesome dyskinesia, is assessed using patient diaries. Impact of dyskinesia on daily activities is quantified using a PDYS-26 questionnaire. To explore potential positive or negative impact of Fipamezole on cognitive functions, the study includes two cognitive tests. Finally, the study includes investigator assessments of CGI-I scales for dyskinesia, Parkinson's disease, and clinical condition in general.
- Conditions
- Parkinson's Disease
- Being tested
- fipamezole
- Keywords
- dyskinesia, movement disorders, basal ganglia diseases, JP-1730, Parkinson, end-of-dose wearing off, fluctuations
- Medical subject headings
- Parkinson Disease, Dyskinesias, Movement Disorders, Basal Ganglia Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fipamezoleDrug
Also called JP-1730
Fipamezole in Zydis formulation three times per day for up to 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | One placebo tablet administered tid from Day 1 to 28 Receives: Drug: fipamezole |
| 2 | Active comparator | One 30-mg tablet of Fipamezole tid from Day 1 to 28 Receives: Drug: fipamezole |
| 3 | Active comparator | One 30-mg tablet of Fipamezole tid from Day 1 to 7; and one 60-mg tablet of Fipamezole tid from Day 8 to 28 Receives: Drug: fipamezole |
| 4 | Active comparator | One 30-mg tablet of Fipamezole tid from Day 1 to 7; one 60-mg tablet of Fipamezole tid from Day 8 to 14; and one 90-mg tablet of Fipamezole tid from Day 15 to 28 Receives: Drug: fipamezole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale.
Measured: 28-days treatment
Secondary outcomes (1)
To compare efficacy of 3 different doses of fipamezole with that of placebo on the mean daily 'Off' time, as recorded in the patient diary.
Measured: 28-days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2009
- Study completionMay 2009
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juvantia Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Santhera Pharmaceuticals
- Investigators
- Peter A. LeWitt, M.D., Principal investigator, Henry Ford Health Systems, Franklin Pointe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559871
- Sponsor's protocol ID
- SNT-II-004
- Acronym
- Fjord
- Status last verified
- Jun 2009
- First submitted
- 15 Nov 2007
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Efficacy, Safety and Tolerability of Fipamezole as an Oromucosal Fast Dissolving Tablet in the Treatment of Parkinson's Disease Patients.
- ClinicalTrials.gov ID
- NCT00559871
- Acronym / sponsor ID
- Fjord / SNT-II-004
- Conditions
- Parkinson's Disease
- Keywords
- dyskinesia, movement disorders, basal ganglia diseases, JP-1730, Parkinson, end-of-dose wearing off, fluctuations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Juvantia Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Santhera Pharmaceuticals
- Study start
- Oct 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Nov 2007 (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 study is to determine whether Fipamezole is effective in the treatment of levodopa-induced dyskinesia in advanced Parkinson's disease.
Detailed description
This study is a multi-center, double-blind, placebo-controlled, multiple dose escalating, safety, tolerance, pharmacokinetics, and efficacy study of fipamezole administered in Parkinson's disease patients who are concomitantly being treated with a combination product of levodopa with a dopamine decarboxylase inhibitor (DDI) and possible other antiparkinson medication. Approximately 30 sites in the US and India will participate in this study. The patients will be randomized into one of four treatment arms to receive either fixed or ascending doses of Fipamezole (from 30 to 90 mg tid) or placebo. For efficacy assessments, levodopa-induced dyskinesia is assessed using a standardised rating scale. Time spent in 'Off' state or in 'On' state without dyskinesia, 'On' with non-troublesome dyskinesia or 'On' with troublesome dyskinesia, is assessed using patient diaries. Impact of dyskinesia on daily activities is quantified using a PDYS-26 questionnaire. To explore potential positive or negative impact of Fipamezole on cognitive functions, the study includes two cognitive tests. Finally, the study includes investigator assessments of CGI-I scales for dyskinesia, Parkinson's disease, and clinical condition in general.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: fipamezoleOne placebo tablet administered tid from Day 1 to 28 |
| 2 | Active comparator | Drug: fipamezoleOne 30-mg tablet of Fipamezole tid from Day 1 to 28 |
| 3 | Active comparator | Drug: fipamezoleOne 30-mg tablet of Fipamezole tid from Day 1 to 7; and one 60-mg tablet of Fipamezole tid from Day 8 to 28 |
| 4 | Active comparator | Drug: fipamezoleOne 30-mg tablet of Fipamezole tid from Day 1 to 7; one 60-mg tablet of Fipamezole tid from Day 8 to 14; and one 90-mg tablet of Fipamezole tid from Day 15 to 28 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| fipamezoleAlso: JP-1730Fipamezole in Zydis formulation three times per day for up to 28 days | Drug | 1, 2, 3, 4 |
Primary outcome
To compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale.
Time frame: 28-days treatment
1 secondary outcome
To compare efficacy of 3 different doses of fipamezole with that of placebo on the mean daily 'Off' time, as recorded in the patient diary.
Time frame: 28-days treatment
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 3 Jun 2009.
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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.
Peter A. LeWitt, M.D. principal investigator
Henry Ford Health Systems, Franklin Pointe Medical Center
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fipamezole in people with Parkinson's Disease, run by Juvantia Pharma Ltd at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale. (time frame: 28-days treatment). 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 3 Jun 2009.