Parkinson's DiseasePhase 1/2NCT00407212
A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
A Phase 1/2 study testing TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt) in people with Parkinson's Disease, run by Novartis at 45 sites in 9 countries.
Trial summary
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
- How many people
- 301 participants
- Where
- 45 sitesin 9 countries
- Study dates
- Jan 2002to Nov 2003
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female ,aged 30-80 years
- Clinical diagnosis of early stage idiopathic Parkinson's disease
- Experiencing two of the three following signs; bradykinesia, rigidity, and tremor
- Not currently taking any antiparkinson medication
Who cannot join
- A history of alcohol or drug abuse in the past year
- A diagnosis psychiatric illness
- Patients who currently are taking MAO inhibitors within 30 days of entering the study
- Patients who are hypersensitive to selegiline, MAO-B inhibitors, or tricyclic antidepressants
- Additional inclusion/exclusion criteria may apply
Trial locations and contacts
45 sites in 9 countries.
45 sites in 9 countries
United States11 sites
Study site
Berkley, California
Study site
Chicago, Illinois
Study site
Columbus, Ohio
Study site
Fountain Valley, California
Study site
Great Falls, Montana
Study site
Houston, Texas
Study site
New Haven, Connecticut
Study site
Pawtucket, Rhode Island
Study site
Phoenix, Arizona
Study site
Southfield, Michigan
Study site
Sunnyvale, California
Canada6 sites
Novartis Investigative Site
Caligary
Novartis Investigative Site
Hallifax
Novartis Investigative Site
Markham
Novartis Investigative Site
Montreal
Novartis Investigative Site
Vancouver
Novartis Investigative Site
Winnipeg
Netherlands6 sites
Study site
's-Hertogenbosch
Study site
Amsterdam
Study site
Bedra
Study site
Biaricum
Study site
Dordrecht
Study site
Groningen
France5 sites
Novartis Investigative Site
Clermont
Study site
Marseille
Novartis Investigative Site
Paris
Study site
Saint-Herblain
Study site
Tours
Italy5 sites
Study site
Genova
Study site
Lido di Camaiore
Study site
Maples
Study site
Milan
Study site
Pescara
Brazil4 sites
Novartis Investigative Site
Belo Horizonte
Novartis Investigative Site
Curitiba
Novartis Investigative Site
Fortaleza
Novartis Investigative Site
São Paulo
Germany4 sites
Study site
Berlin
Study site
Bochum
Study site
Leipzig
Study site
Wiesbaden
United Kingdom3 sites
Study site
Birmingham
Study site
Cambridge
Study site
Sheffield
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
Read the detailed description
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
- Conditions
- Parkinson's Disease
- Being tested
- TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)
- Keywords
- early stage idiopathic Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the need for symptomatic treatment with dopaminergic agents", defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator
Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.
Secondary outcomes (3)
Annual change rates for Unified Parkinsons Disease Rating Scalescore
Changes in UPDRS score after 4 weeks and after withdrawal of study treatment
Percentage of patients needing symptomatic treatment within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startJan 2002
- Primary completionNov 2003
- Study completionNov 2003
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407212
- Sponsor's protocol ID
- TCH346B103
- Status last verified
- Nov 2011
- First submitted
- 30 Nov 2006
- Last updated
- 23 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00407212
- Acronym / sponsor ID
- TCH346B103
- Conditions
- Parkinson's Disease
- Keywords
- early stage idiopathic Parkinson's disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 4 Dec 2006 (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.
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
Detailed description
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ,aged 30-80 years
- Clinical diagnosis of early stage idiopathic Parkinson's disease
- Experiencing two of the three following signs; bradykinesia, rigidity, and tremor
- Not currently taking any antiparkinson medication
Key exclusion criteria (5 listed)
- A history of alcohol or drug abuse in the past year
- A diagnosis psychiatric illness
- Patients who currently are taking MAO inhibitors within 30 days of entering the study
- Patients who are hypersensitive to selegiline, MAO-B inhibitors, or tricyclic antidepressants
- Additional inclusion/exclusion criteria may apply
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 |
|---|---|---|
| TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt) | Drug | – |
Primary outcome
Time to the need for symptomatic treatment with dopaminergic agents", defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator
Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.
3 secondary outcomes
Annual change rates for Unified Parkinsons Disease Rating Scalescore
Changes in UPDRS score after 4 weeks and after withdrawal of study treatment
Percentage of patients needing symptomatic treatment within 12 months
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 23 Nov 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt) in people with Parkinson's Disease, run by Novartis at 45 sites in 9 countries.
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 4 inclusion and 5 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 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada, Netherlands, France, Italy and 4 more countries. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Time to the need for symptomatic treatment with dopaminergic agents", defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator. The study lists 2 primary outcomes in all. 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 23 Nov 2011.