Idiopathic Parkinson's Disease MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Safinamide
CAS Number: 202825-46-5
Current Sponsor code: NW-1015
Concentration unit: mg milligram
Sponsors
Merck Serono SA - Geneva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria: 1. The subject completed 24 weeks of treatment in trial 27919. 2. The subject successfully completed all trial requirements in trial 27919. 3. If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.9 of the protocol for four weeks prior to, during and four weeks after the last dose of study 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”. 4. Subject is willing and able to participate in the trial and has provided written, informed consent. 5. Be able to maintain an accurate and complete diary (18-hour), with the help of a caregiver, recording “on” time, “on” time with minor dyskinesia, “on” time with troublesome dyskinesia, “off” time and time asleep. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for inclusion in this trial the subjects must not meet any of the following criteria: 1. If female, the subject is pregnant or lactating. 2. The subject experienced a clinically significant adverse effect during trial 27919 that could put the subject at risk according to the investigator’s opinion. 3. The subject has shown clinically significant deterioration during participation in trial 27919. 4. Motor deterioration during trial 27919 that requires upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication. 5. The investigator deems it is not in the subject’s best interest to participate to trial 27937. 6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the change from baseline to W78 in dyskinesia using the Dyskinesia Rating Scale during the “on” phase, comparing safinamide (50-100 mg/day) to placebo.;Secondary Objective: The secondary objectives are to evaluate the changes from baseline to W78 in motor fluctuations, motor function, activities of daily living, quality of life, change in global clinical status, change in levodopa dose, and cognition. Evaluate the changes from baseline to W78 in depression, disease staging, cognition and Health Resource Utilization.;Primary end point(s): Dyskinesia Rating Scale score during the “on” phase change from baseline to W78 | — |
Countries
Austria, Estonia, Hungary, United Kingdom
Outcome results
None listed