Health Condition 1: null- Parkinsons Disease
Conditions
Interventions
Intervention1: Safinamide: 50 - 100mg p.o./day
Control Intervention1: Nil: Nil
Sponsors
Merck Serono
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject has completed a previous clinical study with safinamide in PD, and; 2. The subject successfully completed all trial requirements of the antecedent trial, and; 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 for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive, and; 4. Subjects must be willing and able to participate in the trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. The subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with safinamide. 2. If female, the subject is pregnant or lactating. 3. Any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject?s ability to participate in this open-label trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical and neurological examinations, vital signs, laboratory evaluations, electrocardiograms, AEs, UPDRS, dermatologic examinations, and ophthalmological examinationsTimepoint: Change from baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactMr Suneela Thatte
Outcome results
None listed