Parkinson's DiseasePhase 2NCT02439125
A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients
A Phase 2 study testing Eltoprazine HCl in people with Parkinson's Disease and Dyskinesia, run by Amarantus BioScience Holdings, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of eltoprazine to treat levodopa-induced dyskinesia in patients with Parkinson's disease Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson's Disease, Dyskinesia
- What is being tested?
- Eltoprazine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2017
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatient with idiopathic PD
- stable dose of anti-parkinsonian medication for at least four weeks before the Screening Visit
- daily levodopa dose ≥300 mg per day divided into at least three doses
- treated with levodopa for at least three years prior to study entry
- moderate to severely disabling levodopa-induced dyskinesia for at least three months prior to study entry
- dyskinesia for, on average, >25% of the waking day
Who cannot join
- inability to use the motion sensors or electronic diaries correctly
- surgical treatment for PD, e.g. Deep Brain Stimulation, within the last six months or planned during the study
- unstable co-existing psychiatric disease including psychosis, depression or cognitive impairment
- Mini Mental State Examination score of <24
- moderate or severe renal, or severe hepatic, impairment
- treatment with selective serotonin re-uptake inhibitors (SSRI) or any combined serotonin-norepinephrine re-uptake inhibitors (SNRI), such as tryptizol, citalopram, escitalopram, sertraline, mianserin, mirtazapin, paroxetin, venlafaxine and St John's Wort, within four weeks prior to the Screening Visit
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- treatment with medications with the potential for drug-interactions (MAO-A inhibitors, apomorphine, aripiprazol, carbamazepine, clozapine, phenytoin, tramadol, quetiapine, varfaine, valproic acid). Patients taking amantadine will comprise no more than 25% of the study population
- current history of a clinically significant and uncontrolled medical condition that may affect the safety of the patient or preclude adequate participation in the study
- pregnant or breast-feeding
- received any other investigational medicinal product within 30 days of Screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkinson's Disease and Movement Disorders Center, Boca Raton
Boca Raton, Florida, 33486
About this study
Official title: Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease
The purpose of this study is to evaluate the safety, tolerability and efficacy of eltoprazine to treat levodopa-induced dyskinesia in patients with Parkinson's disease
Read the detailed description
A double-blind, placebo-controlled, crossover, dose-range finding study in patients with Parkinson's disease and levodopa-induced dyskinesia. The study will examine the effects of three different doses of eltoprazine HCl, compared to placebo, on severity of dyskinesia, parkinsonian symptoms, patient function, safety and tolerability, using Parkinson's disease rating scales, patient diaries and physiological measurement of abnormal movement by means of motion sensors.
- Conditions
- Parkinson's Disease, Dyskinesia
- Being tested
- Eltoprazine HCl, Placebo
- Keywords
- levodopa, dyskinesia, parkinsons disease, PD
- 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.
Eltoprazine HClDrug
2.5 mg b.i.d. orally for 3 weeks
Eltoprazine HClDrug
5.0 mg b.i.d. orally for 3 weeks
Eltoprazine HClDrug
7.5 mg b.i.d. orally for 3 weeks
PlaceboDrug
b.i.d. orally for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Eltoprazine HCl 2.5 mg | Experimental | Eltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) for 3 weeks Receives: Drug: Eltoprazine HCl |
| Eltoprazine HCl 5.0 mg | Experimental | Eltoprazine HCl 5.0 mg capsules to be taken orally b.i.d. (ie, 10 mg/day) for 3 weeks Receives: Drug: Eltoprazine HCl |
| Eltoprazine HCl 7.5 mg | Experimental | Eltoprazine HCl 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks Receives: Drug: Eltoprazine HCl |
| Placebo | Placebo comparator | Placebo capsules to be taken orally b.i.d. for 3 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
Clinical impact on dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score at the end of each Treatment Period on Days 21, 42, 63 and 84
Measured: 84 days
Secondary outcomes (4)
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
- PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
Measured: 84 days
Dyskinesia severity using physiological motion sensor system
Dyskinesia severity using physiological motion sensor system
Measured: 84 days
Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.
Patient function using MDS-UPDRS and UDysRS questionnaires
Measured: 84 days
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
Measured: 94 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amarantus BioScience Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlotte Keywood, MBBS,MRCP,, Study director, Amarantus BioScience Holdings, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439125
- Sponsor's protocol ID
- AMBS-ELTO-201
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2015
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Svenningsson P, Rosenblad C, Af Edholm Arvidsson K, Wictorin K, Keywood C, Shankar B, Lowe DA, Bjorklund A, Widner H. Eltoprazine counteracts l-DOPA-induced dyskinesias in Parkinson's disease: a dose-finding study. Brain. 2015 Apr;138(Pt 4):963-73. doi: 10.1093/brain/awu409. Epub 2015 Feb 10.
PubMed 25669730McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
PubMed 31356217
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02439125
- Acronym / sponsor ID
- AMBS-ELTO-201
- Conditions
- Parkinson's Disease, Dyskinesia
- Keywords
- levodopa, dyskinesia, parkinsons disease, PD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Amarantus BioScience Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 May 2015 (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 evaluate the safety, tolerability and efficacy of eltoprazine to treat levodopa-induced dyskinesia in patients with Parkinson's disease
Detailed description
A double-blind, placebo-controlled, crossover, dose-range finding study in patients with Parkinson's disease and levodopa-induced dyskinesia. The study will examine the effects of three different doses of eltoprazine HCl, compared to placebo, on severity of dyskinesia, parkinsonian symptoms, patient function, safety and tolerability, using Parkinson's disease rating scales, patient diaries and physiological measurement of abnormal movement by means of motion sensors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eltoprazine HCl 2.5 mg | Experimental | Drug: Eltoprazine HClEltoprazine HCl 2.5 mg capsules to be taken orally b.i.d. (ie, 5 mg/day) for 3 weeks |
| Eltoprazine HCl 5.0 mg | Experimental | Drug: Eltoprazine HClEltoprazine HCl 5.0 mg capsules to be taken orally b.i.d. (ie, 10 mg/day) for 3 weeks |
| Eltoprazine HCl 7.5 mg | Experimental | Drug: Eltoprazine HClEltoprazine HCl 7.5 mg capsules to be taken orally b.i.d. (ie, 15 mg/day) for 3 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules to be taken orally b.i.d. for 3 weeks |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- outpatient with idiopathic PD
- stable dose of anti-parkinsonian medication for at least four weeks before the Screening Visit
- daily levodopa dose ≥300 mg per day divided into at least three doses
- treated with levodopa for at least three years prior to study entry
- moderate to severely disabling levodopa-induced dyskinesia for at least three months prior to study entry
Key exclusion criteria (10 listed)
- inability to use the motion sensors or electronic diaries correctly
- surgical treatment for PD, e.g. Deep Brain Stimulation, within the last six months or planned during the study
- unstable co-existing psychiatric disease including psychosis, depression or cognitive impairment
- Mini Mental State Examination score of <24
- moderate or severe renal, or severe hepatic, impairment
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 |
|---|---|---|
| Eltoprazine HCl2.5 mg b.i.d. orally for 3 weeks | Drug | Eltoprazine HCl 2.5 mg |
| Eltoprazine HCl5.0 mg b.i.d. orally for 3 weeks | Drug | Eltoprazine HCl 5.0 mg |
| Eltoprazine HCl7.5 mg b.i.d. orally for 3 weeks | Drug | Eltoprazine HCl 7.5 mg |
| Placebob.i.d. orally for 3 weeks | Drug | Placebo |
Primary outcome
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
Time frame: 84 days
Clinical impact on dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score at the end of each Treatment Period on Days 21, 42, 63 and 84
4 secondary outcomes
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
Time frame: 84 days
Dyskinesia severity using physiological motion sensor system
Time frame: 84 days
Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.
Time frame: 84 days
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
Time frame: 94 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Results publication: PubMed 25669730Svenningsson P, Rosenblad C, Af Edholm Arvidsson K, Wictorin K, Keywood C, Shankar B, Lowe DA, Bjorklund A, Widner H. Eltoprazine counteracts l-DOPA-induced dyskinesias in Parkinson's disease: a dose-finding study. Brain. 2015 Apr;138(Pt 4):963-73. doi: 10.1093/brain/awu409. Epub 2015 Feb 10.
- Derived from this study: PubMed 31356217McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
- Related InfoLink 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.
Charlotte Keywood, MBBS,MRCP, study director
Amarantus BioScience Holdings, Inc.
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 Eltoprazine HCl in people with Parkinson's Disease and Dyskinesia, run by Amarantus BioScience Holdings, Inc. at 1 site in United States.
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 6 inclusion and 10 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 22 Apr 2016. 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 United States. 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. 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 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?
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?
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score (time frame: 84 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 NCT02439125, which also lists 2 linked publications.
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 22 Apr 2016.