Idiopathic Parkinson's DiseasePhase 1NCT00115427
Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
A Phase 1 study testing Liatermin (r-metHuGDNF) in people with Idiopathic Parkinson's Disease, run by Amgen.
Trial summary
This randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic, levodopa-response Parkinson's disease. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Liatermin (r-metHuGDNF)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2003to not given
- Phase
- Phase 1
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
This randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic, levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period followed by implantation of the IPu delivery system and then a 6-month double-blind treatment period.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Liatermin (r-metHuGDNF)
- Keywords
- Bilateral, 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.
Liatermin (r-metHuGDNF)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
United Parkinson's Disease Rating Scale
Secondary outcomes (4)
Timed Motor Tests
Dyskinesia ratings
Diary ratings
Patient reported outcomes measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2005 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115427
- Sponsor's protocol ID
- 20020168
- Status last verified
- Jan 2008
- First submitted
- 22 Jun 2005
- Last updated
- 11 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00115427
- Acronym / sponsor ID
- 20020168
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Bilateral, Idiopathic Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- First posted
- 23 Jun 2005 (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 randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic, levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period followed by implantation of the IPu delivery system and then a 6-month double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 70 years
- 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 |
|---|---|---|
| Liatermin (r-metHuGDNF) | Drug | – |
Primary outcome
United Parkinson's Disease Rating Scale
4 secondary outcomes
Timed Motor Tests
Dyskinesia ratings
Diary ratings
Patient reported outcomes measures
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 11 Jan 2008.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liatermin (r-metHuGDNF) in people with Idiopathic Parkinson's Disease, run by Amgen.
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 11 Jan 2008. 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. 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 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.
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?
United Parkinson's Disease Rating Scale. 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 11 Jan 2008.