Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects
NCT ID: NCT01113320
Last Updated: 2013-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2010-04-30
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
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
Safinamide
Safinamide
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
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
Safinamide
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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
3. The subject is an out-patient aged 30 years or above.
4. PD subjects with a Hoehn and Yahr disease staging of II-IV (in the ON state).
5. PD subjects experiencing levodopa induced dyskinesias, specifically predictable peak-dose dyskinesia.
6. Peak-dose dyskinesia must be considered by the subject to be problematic and/or disabling.
7. Peak-dose dyskinesia must warrant medical treatment in the Investigator's opinion.
8. The subject has participated successfully in a diary-card training session.
9. 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).
10. 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.
11. The dose of levodopa and all PD drugs used during the trial must remain unchanged throughout the trial.
12. Female subjects must be neither pregnant or breast-feeding and must lack child-bearing potential, as defined either by:
1. be either post menopausal for at least 2 years , surgically sterilised or have undergone hysterectomy, or
2. 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.
13. The subject shows adequate compliance with the schedule for intake of trial medication and the completion of the diaries.
Exclusion Criteria
2. The subject is experiencing exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesias without peak dose dyskinesia.
3. (For female subjects) The subject is pregnant or lactating.
4. Treatment with a MAO-B inhibitor within the eight weeks prior to the screening visit.
5. Treatment with amantadine in the four weeks prior to the screening visit or budipine in the eight weeks prior to the screening visit.
6. 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.
7. 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.
8. 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.
9. Neoplastic disorder, which is either currently active or has been in remission for less than one year.
10. Diagnosis of HIV, or positive test for Hepatitis C antibodies, or Hepatitis B surface antigen.
11. Concomitant disease likely to interfere with trial medication (e.g. capable of altering absorption, metabolism, or elimination of the trial drug).
12. 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.
13. 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.
14. 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
15. 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.
16. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
17. Known hypersensitivity to the trial treatment(s), including placebo or other comparator drug(s).
18. The subject has legal incapacity or limited legal capacity.
19. The subject is participating in another clinical trial or has done so within the past 30 days
20. 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.
21. Subjects with current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past three months.
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Newron Pharmaceuticals SPA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan Willmer, MD
Role: STUDY_DIRECTOR
Merck Serono S.A., Geneva
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University Graz, Klinische Abteilung für Spezielle Neurologie
Graz, , Austria
Medical University Innsbruck, Dept. of Neurology
Innsbruck, , Austria
Quebec Memory and Motor Skills Disorders
Québec, , Canada
Hôpital Roger Sallengro
Lille, , France
CIC-Hospital Purpan
Toulouse, , France
Neurologie Berlin Praxen
Berlin, , Germany
St. Josef Hospital, Klinik für Neurologie
Bochum, , Germany
Facharzt für Neurologie und Psychiatrie
Düsseldorf, , Germany
Medical and Dental center (ZAF)
Johannesburg, , South Africa
Sunninghill Hospital
Johannesburg, , South Africa
Willows Medical Centre
Pretoria, , South Africa
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EMR701165_023
Identifier Type: -
Identifier Source: org_study_id