Parkinson's DiseasePhase 2Safinamide-LIDNCT01113320
Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects
A Phase 2 study testing Safinamide in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA at 11 sites in 5 countries.
Trial summary
Approximately twenty four (24) subjects will participate in this research trial. The research trial will be conducted in approximately twelve (12) medical centers in the following countries: Germany, France, South Africa, Austria and Canada. The research trial will last until December 2011. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Safinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Apr 2010to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has given his/her written informed consent to participate in the trial.
- The subject presents with a diagnosis of idiopathic Parkinson's disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria
- The subject is an out-patient aged 30 years or above.
- PD subjects with a Hoehn and Yahr disease staging of II-IV (in the ON state).
- PD subjects experiencing levodopa induced dyskinesias, specifically predictable peak-dose dyskinesia.
- Peak-dose dyskinesia must be considered by the subject to be problematic and/or disabling.
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- Peak-dose dyskinesia must warrant medical treatment in the Investigator's opinion.
- The subject has participated successfully in a diary-card training session.
- In the judgment of the Investigator based on the subject's history, previous treatments, and the clinical presentation, the subject is considered as being optimally treated at screening (i.e., further adjustments of current medication will not further improve the subject's symptoms of Parkinson's disease).
- Stable dose of PD drugs for at least 4 weeks before Screening Visit. This may include: levodopa dopamine agonists, c-ortho methyl transferase (COMT) inhibitors, and anticholinergics.
- The dose of levodopa and all PD drugs used during the trial must remain unchanged throughout the trial.
- Female subjects must be neither pregnant or breast-feeding and must lack child-bearing potential, as defined either by:
- be either post menopausal for at least 2 years , surgically sterilised or have undergone hysterectomy, or
- if of child bearing potential, be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
- The subject shows adequate compliance with the schedule for intake of trial medication and the completion of the diaries.
Who cannot join
- The subject has participated in any safinamide clinical trial before.
- The subject is experiencing exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesias without peak dose dyskinesia.
- (For female subjects) The subject is pregnant or lactating.
- Treatment with a MAO-B inhibitor within the eight weeks prior to the screening visit.
- Treatment with amantadine in the four weeks prior to the screening visit or budipine in the eight weeks prior to the screening visit.
- Treatment with opioids (e.g., tramadol, meperidine derivatives), serotonin norepinephrine reuptake inhibitors (SNRIs) (e.g. venlafaxine, duloxetine), tri- or tetra-cyclic antidepressants, in the past 8 weeks prior to the screening visit. Dextromethorphan will be permitted if used for treating cough.
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- The subject has received neurosurgical intervention related to PD (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the trial period.
- Current clinically significant gastro-intestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and unstable Type I diabetes. Subjects with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion.
- Neoplastic disorder, which is either currently active or has been in remission for less than one year.
- Diagnosis of HIV, or positive test for Hepatitis C antibodies, or Hepatitis B surface antigen.
- Concomitant disease likely to interfere with trial medication (e.g. capable of altering absorption, metabolism, or elimination of the trial drug).
- The subject has any clinically significant illness that, in the Investigator's opinion, might interfere with the subject's ability to participate in the trial.
- Second- or third-degree atrio-ventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or a significant ECG abnormality, including corrected QT interval (QTc) - 450 msec (males) or - 470 msec (females), where QTc is based on Bazett's correction method.
- Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy
- The subject is suffering from any dementia or other psychiatric illness that prevents him/her from giving informed consent, i.e. Montreal Cognitive Assessment (MoCA) <23 points.
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- Known hypersensitivity to the trial treatment(s), including placebo or other comparator drug(s).
- The subject has legal incapacity or limited legal capacity.
- The subject is participating in another clinical trial or has done so within the past 30 days
- Treatment with a drug that has hepatotoxic potential, e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g, chemotherapy, within one year prior to the screening visit.
- Subjects with current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past three months.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Germany3 sites
Neurologie Berlin Praxen
Berlin
St. Josef Hospital, Klinik für Neurologie
Bochum
Facharzt für Neurologie und Psychiatrie
Düsseldorf
South Africa3 sites
Medical and Dental center (ZAF)
Johannesburg
Sunninghill Hospital
Johannesburg
Willows Medical Centre
Pretoria
Austria2 sites
Medical University Graz, Klinische Abteilung für Spezielle Neurologie
Graz
Medical University Innsbruck, Dept. of Neurology
Innsbruck
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias
Approximately twenty four (24) subjects will participate in this research trial. The research trial will be conducted in approximately twelve (12) medical centers in the following countries: Germany, France, South Africa, Austria and Canada. The research trial will last until December 2011.
- Conditions
- Parkinson's Disease
- Being tested
- Placebo, Safinamide
- Keywords
- Safinamide - Parkinson's disease - Levodopa induced dyskinesia, Advanced idiopathic PD patients treated with L-dopa and suffering from temporally predictable L-dopa induced peak-dose dyskinesia.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide and identical Placebo will be provided in tablets equivalent of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths
SafinamideDrug
Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide will be provided in tablets of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Safinamide | Active comparator | Not described Receives: Drug: Safinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum reduction in Unified Dyskinesia Rating Score (UDysRS) compared to baseline across all post-baseline dose visits.
Measured: Day 66
Secondary outcomes (36)
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Measured: At each individual post-dose visit: Baseline
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Measured: At each individual post-dose visit: Day 8
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Measured: At each individual post-dose visit: Day 22
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Measured: At each individual post-dose visit: Day 36
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Measured: At each individual post-dose visit: Day 66
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Measured: At each individual post-dose visit: Day 101
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Measured: At each individual visit: Baseline
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Measured: At each individual visit: Day 8
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Measured: At each individual visit: Day 22
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Measured: At each individual visit: Day 36
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Measured: At each individual visit: Day 66
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Measured: At each individual visit: Day 101
Patient's diary (Hauser diary, all parts)
Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period.
Measured: At each trial visit: Baseline
Patient's diary (Hauser diary, all parts)
Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period.
Measured: At each trial visit: Day 8
Patient's diary (Hauser diary, all parts)
Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period.
Measured: At each trial visit: Day 22
Patient's diary (Hauser diary, all parts)
Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period.
Measured: At each trial visit: Day 36
Patient's diary (Hauser diary, all parts)
Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period.
Measured: At each trial visit: Day 66
Patient's diary (Hauser diary, all parts)
Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period.
Measured: At each trial visit: Day 101
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Measured: At each trial visit: Baseline
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Measured: At each trial visit: Day 8
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Measured: At each trial visit: Day 22
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Measured: At each trial visit: Day 36
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Measured: At each trial visit: Day 66
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Measured: At each trial visit: Day 101
Clinical Global Impression (CGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Baseline
Clinical Global Impression (CGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 8
Clinical Global Impression (CGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 22
Clinical Global Impression (CGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 36
Clinical Global Impression (CGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 66
Clinical Global Impression (CGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 101
Patient Global Impression (PGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Baseline
Patient Global Impression (PGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 8
Patient Global Impression (PGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 22
Patient Global Impression (PGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 36
Patient Global Impression (PGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 66
Patient Global Impression (PGI) (dyskinesia specific)
Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy.
Measured: At each trial visit: Day 101
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Willmer, MD, Study director, Merck Serono S.A., Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113320
- Sponsor's protocol ID
- EMR701165_023
- Acronym
- Safinamide-LID
- Status last verified
- Jan 2012
- First submitted
- 8 Apr 2010
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias
- ClinicalTrials.gov ID
- NCT01113320
- Acronym / sponsor ID
- Safinamide-LID / EMR701165_023
- Conditions
- Parkinson's Disease
- Keywords
- Safinamide - Parkinson's disease - Levodopa induced dyskinesia, Advanced idiopathic PD patients treated with L-dopa and suffering from temporally predictable L-dopa induced peak-dose dyskinesia.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Apr 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.
Approximately twenty four (24) subjects will participate in this research trial. The research trial will be conducted in approximately twelve (12) medical centers in the following countries: Germany, France, South Africa, Austria and Canada. The research trial will last until December 2011.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Safinamide | Active comparator | Drug: Safinamide |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject has given his/her written informed consent to participate in the trial.
- The subject presents with a diagnosis of idiopathic Parkinson's disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria
- The subject is an out-patient aged 30 years or above.
- PD subjects with a Hoehn and Yahr disease staging of II-IV (in the ON state).
- PD subjects experiencing levodopa induced dyskinesias, specifically predictable peak-dose dyskinesia.
Key exclusion criteria (21 listed)
- The subject has participated in any safinamide clinical trial before.
- The subject is experiencing exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesias without peak dose dyskinesia.
- (For female subjects) The subject is pregnant or lactating.
- Treatment with a MAO-B inhibitor within the eight weeks prior to the screening visit.
- Treatment with amantadine in the four weeks prior to the screening visit or budipine in the eight weeks prior to the screening visit.
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 |
|---|---|---|
| PlaceboEvaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide and identical Placebo will be provided in tablets equivalent of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths | Drug | Placebo |
| SafinamideEvaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide will be provided in tablets of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths | Drug | Safinamide |
Primary outcome
The maximum reduction in Unified Dyskinesia Rating Score (UDysRS) compared to baseline across all post-baseline dose visits.
Time frame: Day 66
36 secondary outcomes
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Time frame: At each individual post-dose visit: Baseline
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Time frame: At each individual post-dose visit: Day 8
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Time frame: At each individual post-dose visit: Day 22
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Time frame: At each individual post-dose visit: Day 36
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Time frame: At each individual post-dose visit: Day 66
Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales
Time frame: At each individual post-dose visit: Day 101
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Time frame: At each individual visit: Baseline
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Time frame: At each individual visit: Day 8
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Time frame: At each individual visit: Day 22
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Time frame: At each individual visit: Day 36
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Time frame: At each individual visit: Day 66
Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective)
Time frame: At each individual visit: Day 101
Patient's diary (Hauser diary, all parts)
Time frame: At each trial visit: Baseline
Patient's diary (Hauser diary, all parts)
Time frame: At each trial visit: Day 8
Patient's diary (Hauser diary, all parts)
Time frame: At each trial visit: Day 22
Patient's diary (Hauser diary, all parts)
Time frame: At each trial visit: Day 36
Patient's diary (Hauser diary, all parts)
Time frame: At each trial visit: Day 66
Patient's diary (Hauser diary, all parts)
Time frame: At each trial visit: Day 101
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Time frame: At each trial visit: Baseline
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Time frame: At each trial visit: Day 8
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Time frame: At each trial visit: Day 22
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Time frame: At each trial visit: Day 36
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Time frame: At each trial visit: Day 66
Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire)
Time frame: At each trial visit: Day 101
Clinical Global Impression (CGI) (dyskinesia specific)
Time frame: At each trial visit: Baseline
Clinical Global Impression (CGI) (dyskinesia specific)
Time frame: At each trial visit: Day 8
Clinical Global Impression (CGI) (dyskinesia specific)
Time frame: At each trial visit: Day 22
Clinical Global Impression (CGI) (dyskinesia specific)
Time frame: At each trial visit: Day 36
Clinical Global Impression (CGI) (dyskinesia specific)
Time frame: At each trial visit: Day 66
Clinical Global Impression (CGI) (dyskinesia specific)
Time frame: At each trial visit: Day 101
Patient Global Impression (PGI) (dyskinesia specific)
Time frame: At each trial visit: Baseline
Patient Global Impression (PGI) (dyskinesia specific)
Time frame: At each trial visit: Day 8
Patient Global Impression (PGI) (dyskinesia specific)
Time frame: At each trial visit: Day 22
Patient Global Impression (PGI) (dyskinesia specific)
Time frame: At each trial visit: Day 36
Patient Global Impression (PGI) (dyskinesia specific)
Time frame: At each trial visit: Day 66
Patient Global Impression (PGI) (dyskinesia specific)
Time frame: At each trial visit: Day 101
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 29 Mar 2013.
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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.
Jonathan Willmer, MD study director
Merck Serono S.A., Geneva
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Safinamide in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA at 11 sites in 5 countries.
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 15 inclusion and 21 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: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, South Africa, Austria, France, Canada. 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?
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?
The maximum reduction in Unified Dyskinesia Rating Score (UDysRS) compared to baseline across all post-baseline dose visits. (time frame: Day 66). 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 2013.