Parkinson DiseasePhase 2NCT00600093
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
A Phase 2 study testing Amantadine in people with Parkinson Disease and Perioperative Care, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Perioperative Care
- 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
- 1 siteIsrael
- Study dates
- Jan 2008to Jul 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with a diagnosis of Parkinson Disease refered for surgery at our institution.
Who cannot join
- Cardiac and neurosurgical procedures
- Inability to sign informed Consent
- allergy to Amantadine
- Congestive heart failure
- Arrythmia (including bradycardia below 55 bpm)
- renal failure (creatinin above 1.5)
- If a patient will develop agitation or delirium lasting longer then 8 hours he will not receive the second dose of amantadine.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment.
- Conditions
- Parkinson Disease, Perioperative Care
- Being tested
- Amantadine
- Keywords
- Amantadine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
Also called PK MERZ
IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).
Measured: 28 days
Secondary outcomes (2)
UPDRS score
Measured: 2,28 days
Pain (vas score), Analgetic drugs requirement
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: PI leaving the institute for a fellowship.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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
- Investigators
- Aeyal Raz, MD,PhD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600093
- Sponsor's protocol ID
- 4332
- Status last verified
- Jul 2011
- First submitted
- 13 Jan 2008
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Raz A, Lev N, Orbach-Zinger S, Djaldetti R. Safety of perioperative treatment with intravenous amantadine in patients with Parkinson disease. Clin Neuropharmacol. 2013 Sep-Oct;36(5):166-9. doi: 10.1097/WNF.0b013e31829bd066.
PubMed 24045608
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
- ClinicalTrials.gov ID
- NCT00600093
- Acronym / sponsor ID
- 4332
- Conditions
- Parkinson Disease, Perioperative Care
- Keywords
- Amantadine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving the institute for a fellowship.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Jan 2008 (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 administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Amantadine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with a diagnosis of Parkinson Disease refered for surgery at our institution.
Key exclusion criteria (7 listed)
- Cardiac and neurosurgical procedures
- Inability to sign informed Consent
- allergy to Amantadine
- Congestive heart failure
- Arrythmia (including bradycardia below 55 bpm)
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 MERZIV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery | Drug | A |
Primary outcome
Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).
Time frame: 28 days
2 secondary outcomes
UPDRS score
Time frame: 2,28 days
Pain (vas score), Analgetic drugs requirement
Time frame: 2 days
Results and safety
The study was stopped early (reason given: PI leaving the institute for a fellowship.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
- Derived from this study: PubMed 24045608Raz A, Lev N, Orbach-Zinger S, Djaldetti R. Safety of perioperative treatment with intravenous amantadine in patients with Parkinson disease. Clin Neuropharmacol. 2013 Sep-Oct;36(5):166-9. doi: 10.1097/WNF.0b013e31829bd066.
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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.
Aeyal Raz, MD,PhD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amantadine in people with Parkinson Disease and Perioperative Care, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 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 was stopped early (reason given: PI leaving the institute for a fellowship.). 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?
Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA). (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600093, which also lists 1 linked publication.
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 26 Jul 2011.