DyskinesiasPhase 1/2NCT00036296
Effects of Talampanel on Patients With Advanced Parkinson's Disease
A Phase 1/2 study testing talampanel in people with Dyskinesias and Parkinson Disease, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
The purpose of this research study is to test the safety and effectiveness of the study drug, Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a result of treatment to Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Dyskinesias, Parkinson Disease, Movement Disorders
- What is being tested?
- talampanel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Feb 2007
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Troublesome on-period dyskinesias as defined by a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia sub-score >25% of Duration of dyskinesia during waking hours and 33 must have moderate disability
- Lang-Fahn dyskinesia rating score more than 2 for at least two of the 5 tasks
- Must have Dyskinesia on average 25% of waking hours/day based on Patient Diaries
- Have been diagnosed with Parkinson's disease > 5 years at Screening
Who cannot join
- Previous surgical therapies for PD
- Isolated or predominantly diphasic dyskinesias
- Moderate Dementia
- On disallowed concomitant medications including CYP3A4 inhibitors and inducers, amantadine, etc.
About this study
Official title: Effects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements)
The purpose of this research study is to test the safety and effectiveness of the study drug, Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a result of treatment to Parkinson's disease.
It is not clear why people with Parkinson's disease develop involuntary movements (dyskinesias) but studies show that blocking receptors in the brain for a chemical called glutamate decreases these movements. Talampanel is a drug which blocks these receptors.
- Conditions
- Dyskinesias, Parkinson Disease, Movement Disorders
- Being tested
- talampanel
- Keywords
- Involuntary Movements, Abnormal Movements, Advanced Parkinson's disease, Levodopa induced dyskinesia
- Medical subject headings
- Dyskinesias, Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talampanelDrug
75mg per day divided into 3 doses for 22 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 75mg per day (in 3 doses) Talampanel for 22 days Receives: Drug: talampanel |
| 2 | Placebo comparator | 3 doses a day for 22 days Receives: Drug: talampanel |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study startDec 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyskinesiasStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036296
- Sponsor's protocol ID
- IXL-202-18-189
- Status last verified
- Oct 2009
- First submitted
- 8 May 2002
- Last updated
- 13 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements)
- ClinicalTrials.gov ID
- NCT00036296
- Acronym / sponsor ID
- IXL-202-18-189
- Conditions
- Dyskinesias, Parkinson Disease, Movement Disorders
- Keywords
- Involuntary Movements, Abnormal Movements, Advanced Parkinson's disease, Levodopa induced dyskinesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 9 May 2002 (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 research study is to test the safety and effectiveness of the study drug, Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a result of treatment to Parkinson's disease.
It is not clear why people with Parkinson's disease develop involuntary movements (dyskinesias) but studies show that blocking receptors in the brain for a chemical called glutamate decreases these movements. Talampanel is a drug which blocks these receptors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: talampanel75mg per day (in 3 doses) Talampanel for 22 days |
| 2 | Placebo comparator | Drug: talampanel3 doses a day for 22 days |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Troublesome on-period dyskinesias as defined by a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia sub-score >25% of Duration of dyskinesia during waking hours and 33 must have moderate disability
- Lang-Fahn dyskinesia rating score more than 2 for at least two of the 5 tasks
- Must have Dyskinesia on average 25% of waking hours/day based on Patient Diaries
- Have been diagnosed with Parkinson's disease > 5 years at Screening
Key exclusion criteria (4 listed)
- Previous surgical therapies for PD
- Isolated or predominantly diphasic dyskinesias
- Moderate Dementia
- On disallowed concomitant medications including CYP3A4 inhibitors and inducers, amantadine, etc.
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 |
|---|---|---|
| talampanel75mg per day divided into 3 doses for 22 days | Drug | 1, 2 |
Primary outcome
Not reported in the source record.
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 13 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing talampanel in people with Dyskinesias and Parkinson Disease, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 4 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 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 13 Apr 2011.