Parkinson DiseaseNCT01190553
Pilot Study of Maintenance Therapy With Intravenous AMANTADINE
A study testing Amantadine in people with Parkinson Disease, run by Rabin Medical Center.
Trial summary
This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with PARKINSON'S Disease who are not well balanced with medical treatment. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Amantadine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jun 2012
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with idiopathic Parkinson disease
- Age<80
- Patients with no motor improvement under optimal treatment with anti parkinson medications
- Patients with moderate to severe dyskinesias
- Patients with PD with side effects who can not tolerate anti parkinson medications
Who cannot join
- Age>80
- Patients with Parkinson syndromes, vascular parkinsonism or drug-induced parkinsonism
- Patients with PD who developed adverse reactions to oral amantadine
- Contraindication of amantadine treatment
About this study
Official title: Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications
This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with PARKINSON'S Disease who are not well balanced with medical treatment.
- Conditions
- Parkinson Disease
- Being tested
- Amantadine
- Keywords
- amantadine, parkinson disease, 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.
AmantadineDrug
Also called PK-Merz
Initiation: IV amantadine 200mg/500ml * 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | IV amantadine treatment Receives: Drug: Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of UPDRS scores after 6 months of treatment
Measured: 6 months
Improvement of dyskinesias score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190553
- Sponsor's protocol ID
- 0166-10-RMC
- Status last verified
- Aug 2010
- First submitted
- 26 Aug 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications
- ClinicalTrials.gov ID
- NCT01190553
- Acronym / sponsor ID
- 0166-10-RMC
- Conditions
- Parkinson Disease
- Keywords
- amantadine, parkinson disease, dyskinesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 27 Aug 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.
This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with PARKINSON'S Disease who are not well balanced with medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: AmantadineIV amantadine treatment |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with idiopathic Parkinson disease
- Age<80
- Patients with no motor improvement under optimal treatment with anti parkinson medications
- Patients with moderate to severe dyskinesias
- Patients with PD with side effects who can not tolerate anti parkinson medications
Key exclusion criteria (4 listed)
- Age>80
- Patients with Parkinson syndromes, vascular parkinsonism or drug-induced parkinsonism
- Patients with PD who developed adverse reactions to oral amantadine
- Contraindication of amantadine treatment
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 |
|---|---|---|
| AmantadineAlso: PK-MerzInitiation: IV amantadine 200mg/500ml * 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months | Drug | Treatment |
Primary outcome
Improvement of UPDRS scores after 6 months of treatment
Time frame: 6 months
Improvement of dyskinesias score.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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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 study testing Amantadine in people with Parkinson Disease, run by Rabin Medical Center.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Oct 2010. 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.
Are results available for this study?
Results are not available in the source record.
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?
Improvement of UPDRS scores after 6 months of treatment (time frame: 6 months). 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 13 Oct 2010.