Health Condition 1: G476- Sleep related movement disorders
Conditions
Interventions
Intervention1: Amantadine
: Patients visiting General Neurology OPD, Movement disorder OPD, General Psychiatry or Sleep OPD or in-patients of Neurology/Psychiatry wards will be screened for RLS (by IR
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: Subjects willing to provide informed written consent and meeting the following criteria will be included in the study: 1. Patients diagnosed to have RLS by IRLSSG diagnostic criteria with chronic persistent symptoms and IRLS total score >=10 2. Patient who are not on treatment for RLS within past 1 month 3. Adult patients >18 years and below 60 years of age.
Exclusion criteria
Exclusion criteria: Subjects will not participate in the study if they meet any of the following criteria: 1. Any symptomatic neuropathies or current diagnosis of clinically relevant concomitant conditions that may confound clinical assessments of RLS and/or severe enough to disturb sleep. 2. Pregnancy 3. Presence of neurodegenerative diseases interfering with administering the questionnaire or interviewing the patient. 4. Use of medications likely to influence sleep architecture or interacting with dopaminergic system: Dopaminergics, sedatives, hypnotics, antipsychotics, cannabis, opioids, opiates 5. Glomerular filtration rate calculated by formula- eGFR 6. Hemoglobin 7. Known hypersensitivity to any components of the trial medication or similar drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in IRLS scale from baseline to 12 weeks in both groups after treatmentTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in RLS-QOL 2. Change in CGI at 12 week 3. Change in ISI: insomnia index 4. Change in sleep architecture: PLMS 5. Any Adverse events Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactGovind madhaw
AIIMS Rishikesh
Outcome results
None listed