Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Intervention1: Safinamide: Administered orally, under double blind conditions. For the first two weeks safinamide 50 mg tablets given and participants to take one tablet daily. From the third week par
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed with IPD(Idiopathic parkinsons disease) 2. Patients with IPD with age 30 years and above with a minimum KPPS score greater than and equal to 4 as well as moderate pain in one of the seven subdomains of the KPSS. Pain must be related to PD and not explained by any other health problem, like Eg: peripheral neuropathy, organ disease, pain related to arthritis etc. Patients can be included if the intensity of these PD unrelated pains are aggravated by PD. 3. Receiving treatment with a stable dose of oral levodopa which includes controlled release, immediate release or a combination of controlled release and immediate release medication or dopamine agonists for at least 4 weeks before randomization.
Exclusion criteria
Exclusion criteria: 1. Patients with other types of parkinsonism, atypical and drug induced. 2. Patients with a diagnosis of or those meeting DSM-V criteria for major depression disorder, Schizophrenia, Bipolar disorder, Substance abuse disorder, other psychotic disorder which requires treatment with anti-psychotic medication. 3. Patients with history of dementia, and cognitive dysfunction 4. Known chronic headache disorder such as chronic migraine more than 15 days a month or cancer related pain. 5. Ophthalmologic diseases like severe hypertensive diabetic/hypertensive retinopathy, inherited or familial retinopathies. 6. Patients with child-pugh score moderate or severe liver failure 7. Contraindications, drug allergy/sensitivity, or intolerance to safinamide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in change of pain scores at 12 weeks using the Kings Parkinsons disease Pain Scale between patients with IPD using safinamide and placeboTimepoint: baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in change of pain scores using the KPPS at 6 weeks between patients with Idiopathic Parkinsons disease using Safinamide and placeboTimepoint: baseline and 6 weeks;The difference in change of scores in motor symptoms using Unified Parkinson disease rating scale- UPDRS III between patients with IPD using Safinamide and placeboTimepoint: baseline, 6 weeks and 12 weeks;The difference in change of scores in quality of life using Parkinsons disease quality of life questionnaire (PDQ-39) between patients with IPD using Safinamide and placebo.Timepoint: baseline, 6 weeks and 12 weeks;The difference in change of scores of clinical global impression of improvement (CGI-I) between patients with IPD using Safinamide and placebo.Timepoint: baseline, 6 weeks and 12 weeks;The difference in change of scores of Non-motor symptoms using Non motor symptoms scale [NMSS] between patients with IPD using Safinamide and placebo.Timepoint: baseline, 6 weeks and 12 weeks;The difference in change of scores of patient global impression of change (PGI-C) between patients with IPD using Safinamide and placebo.Timepoint: baseline, 6 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Ramkumar S
Jipmer
Outcome results
None listed