Levodopa-induced DyskinesiaPhase 1/2NCT00607451
Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia
A Phase 1/2 study testing Neu-120 in people with Levodopa-induced Dyskinesia, run by Neurim Pharmaceuticals Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetic and pharmacodynamic effects of single doses of Neu-120 in Parkinson's disease patients with levodopa-induced dyskinesia. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Levodopa-induced Dyskinesia
- What is being tested?
- Neu-120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to 27 Aug 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 30-80 years old (both ages included).
- Use of adequate and effective birth control measures (not including the rhythm method) during the study period and up to 3 months after the end of study in men and women of child-bearing potential or within two years of menopause (these women will perform a urine pregnancy test at the screening visit)
- Idiopathic Parkinson Disease (UK PD Society Brain Bank Clinical Diagnosis Criteria) diagnosed for at least 3 years.
- Hoehn and Yahr "ON" time (good medication response) stage II-III.
- Treatment with levodopa at an optimized dose alone or with dopamine agonists, MAO-B inhibitors or COMT inhibitors that are stable for at least 4 weeks prior to visit 1
- Use of hypnotics, sedatives, beta-blockers, anxiolytics and antidepressant only if stable for at least 4 weeks prior to visit 1.
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- A minimal baseline Levodopa induced dyskinesia score of 2 or more on question 32 (dyskinesias present during more than 25% of the waking day); a score of 2 or more on question 33 of UPDRS (severely disabling dyskinesias) Part IV (historical information).
- A minimal basal level of motor fluctuations of 25% or more cumulative hours of OFF time every day during waking hours on the UPDRS Part IV (a minimal score of 1 on question 39 of UPDRS, historical information).
- Patients have at least 33% motor improvement in response to their levodopa challenge dose based on UPDRS motor score (Part III) at visit 1.
- Patients experiencing peak-dose dyskinesia with a score of at least 2 on 2 or more (≥2) areas (a score of at least 4) on the modified AIMS scale in response to their levodopa challenge dose at visit 1.
- Patients must be in good general health as determined by medical history, physical examination, ECG, vital signs, serum biochemistry and haematology.
- Patients must have signed an informed consent form .
Who cannot join
- Patient has Non-idiopathic Parkinson's disease (e.g drug-induced or other form of secondary or atypical Parkinsonism).
- Neuropsychiatric exclusions: dementia (Mini Mental State Exam < 23, history or presence of psychosis (such as visual hallucinations while taking dopamine agonists), history of or current Axis I or Axis II mental disorders according to DSM-IV; severe depression (Hamilton scale > 17).
- Any clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
- History or presence of gastrointestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Pregnant or breast feeding women.
- Drug abuse or history of drug abuse (including alcohol), known drug addiction.
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- Patients with severe postural hypotension (> 20 % variability between standing and supine).
- The following medications are forbidden for at least one month prior to visit 1 and during the course of the study: NMDA receptor antagonists (amantadine, memantine, budipine, dextromethorphan), medication with central dopaminergic antagonist activity (neuroleptics), CNS stimulants and sodium valproate (may exacerbate dyskinesias).
- Hoehn and Yahr score V when OFF (wheelchair-bound).
- The patient is participating in another study or has been participating in a study within the last 2 months.
- History of epilepsy and seizures.
- Any history of significant drug allergy.
- A history of unilateral or bilateral intracranial surgical procedures for Parkinson's Disease or any cerebral neurosurgery (except if occurred before the age of 18).
- History of severe pathology likely to recur during or immediately after the study.
- An inability to satisfactorily discontinue any study-forbidden medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo Controlled, Crossover, Ascending Single Dose Safety Tolerability, Pharmacokinetic and Pharmacodynamic Study of Neu-120 in Patients With Advanced Phase Idiopathic Parkinson's Disease With Levodopa Induced Dyskinesia
The purpose of this study is to determine the safety, tolerability, pharmacokinetic and pharmacodynamic effects of single doses of Neu-120 in Parkinson's disease patients with levodopa-induced dyskinesia.
Read the detailed description
Parkinson's disease is a progressive neurological disorder characterized by tremor, bradykinesia, rigidity, gait and postural instability and a variety of nonmotor symptoms. While levodopa effectively alleviates all symptoms of Parkinson's disease and restores motor function, within 3 to 5 years the majority of Parkinsonian patients develop levodopa-induced side effects, mainly dyskinesias (involuntary and uncontrolled movements such as twisting of a hand or a limb) and wearing off (progressive shortening of therapeutic response duration). Dyskinesias are the most disabling side effects of long term levodopa therapy in Parkinsonian patients. There is currently no approved drug for levodopa-induced dyskinesia.
The effects of three single ascending doses of orally administered Neu-120 will be evaluated in a double blind placebo controlled crossover proof of concept study. Following a 1-day screening visit, patients will be randomized to receive three single ascending doses of Neu-120 and placebo.
Patients will be admitted to the clinic on the evening prior to each visit on five occasions, each separated by 7 (-3) days. Levodopa challenges will be performed at baseline (visit 1) and at each treatment visit after withdrawal of all antiparkinsonian medications for 12 hours.
Blood samples will be taken for measurement of Neu-120 and levodopa plasma levels.
Primary parameter is improvement in levodopa-induced dyskinesia. Secondary parameters are safety, tolerability, pharmacodynamic assessments of dyskinesias and motor function, Neu-120/levodopa pharmacokinetic profiles and correlation between pharmacodynamic effects and Neu-120/levodopa levels.
- Conditions
- Levodopa-induced Dyskinesia
- Being tested
- Neu-120
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neu-120Drug
Capsules of 300, 900 and 2700mg; administered as a single dose with a one week washout between each administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Neu-120 |
| 2 | Experimental | Not described Receives: Drug: Neu-120 |
| 3 | Experimental | Not described Receives: Drug: Neu-120 |
| 4 | Experimental | Not described Receives: Drug: Neu-120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving levodopa-induced dyskinesia
Measured: single day
Secondary outcomes (1)
Safety and toleability
Measured: single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startMar 2008
- Primary completion27 Aug 2016
- Study completion27 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Levodopa-induced DyskinesiaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurim Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tali Nir, Study director, Neurim Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607451
- Sponsor's protocol ID
- PoC_12001
- Other IDs
- POC_120-CTIL
- Status last verified
- Mar 2018
- First submitted
- 22 Jan 2008
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled, Crossover, Ascending Single Dose Safety Tolerability, Pharmacokinetic and Pharmacodynamic Study of Neu-120 in Patients With Advanced Phase Idiopathic Parkinson's Disease With Levodopa Induced Dyskinesia
- ClinicalTrials.gov ID
- NCT00607451
- Acronym / sponsor ID
- PoC_12001
- Conditions
- Levodopa-induced Dyskinesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Neurim Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- 27 Aug 2016 (actual)
- Study completion
- 27 Aug 2016 (actual)
- First posted
- 5 Feb 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 the safety, tolerability, pharmacokinetic and pharmacodynamic effects of single doses of Neu-120 in Parkinson's disease patients with levodopa-induced dyskinesia.
Detailed description
Parkinson's disease is a progressive neurological disorder characterized by tremor, bradykinesia, rigidity, gait and postural instability and a variety of nonmotor symptoms. While levodopa effectively alleviates all symptoms of Parkinson's disease and restores motor function, within 3 to 5 years the majority of Parkinsonian patients develop levodopa-induced side effects, mainly dyskinesias (involuntary and uncontrolled movements such as twisting of a hand or a limb) and wearing off (progressive shortening of therapeutic response duration). Dyskinesias are the most disabling side effects of long term levodopa therapy in Parkinsonian patients. There is currently no approved drug for levodopa-induced dyskinesia.
The effects of three single ascending doses of orally administered Neu-120 will be evaluated in a double blind placebo controlled crossover proof of concept study. Following a 1-day screening visit, patients will be randomized to receive three single ascending doses of Neu-120 and placebo.
Patients will be admitted to the clinic on the evening prior to each visit on five occasions, each separated by 7 (-3) days. Levodopa challenges will be performed at baseline (visit 1) and at each treatment visit after withdrawal of all antiparkinsonian medications for 12 hours.
Blood samples will be taken for measurement of Neu-120 and levodopa plasma levels.
Primary parameter is improvement in levodopa-induced dyskinesia. Secondary parameters are safety, tolerability, pharmacodynamic assessments of dyskinesias and motor function, Neu-120/levodopa pharmacokinetic profiles and correlation between pharmacodynamic effects and Neu-120/levodopa levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Neu-120 |
| 2 | Experimental | Drug: Neu-120 |
| 3 | Experimental | Drug: Neu-120 |
| 4 | Experimental | Drug: Neu-120 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female patients aged 30-80 years old (both ages included).
- Use of adequate and effective birth control measures (not including the rhythm method) during the study period and up to 3 months after the end of study in men and women of child-bearing potential or within two years of menopause (these women will perform a urine pregnancy test at the screening visit)
- Idiopathic Parkinson Disease (UK PD Society Brain Bank Clinical Diagnosis Criteria) diagnosed for at least 3 years.
- Hoehn and Yahr "ON" time (good medication response) stage II-III.
- Treatment with levodopa at an optimized dose alone or with dopamine agonists, MAO-B inhibitors or COMT inhibitors that are stable for at least 4 weeks prior to visit 1
Key exclusion criteria (15 listed)
- Patient has Non-idiopathic Parkinson's disease (e.g drug-induced or other form of secondary or atypical Parkinsonism).
- Neuropsychiatric exclusions: dementia (Mini Mental State Exam < 23, history or presence of psychosis (such as visual hallucinations while taking dopamine agonists), history of or current Axis I or Axis II mental disorders according to DSM-IV; severe depression (Hamilton scale > 17).
- Any clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
- History or presence of gastrointestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Pregnant or breast feeding women.
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 |
|---|---|---|
| Neu-120Capsules of 300, 900 and 2700mg; administered as a single dose with a one week washout between each administration. | Drug | 1, 2, 3, 4 |
Primary outcome
Improving levodopa-induced dyskinesia
Time frame: single day
1 secondary outcome
Safety and toleability
Time frame: single dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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.
Tali Nir study director
Neurim Pharmaceutical Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neu-120 in people with Levodopa-induced Dyskinesia, run by Neurim Pharmaceuticals Ltd. 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 12 inclusion and 15 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 29 Mar 2018. 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 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 was stopped early. 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?
Improving levodopa-induced dyskinesia (time frame: single day). 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 29 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.