Parkinson's disease. Parkinson's disease
Conditions
Interventions
Intervention 1: Intervention group: Lisdexamfetamine 30 mg, taken once daily for 6 weeks. Intervention 2: Control group: placebo taken once daily for 6.
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Diagnosis of idiopathic Parkinson’s disease confirmed by a movement disorders (Parkinson’s) fellowship. History of freezing of gait episodes, with a baseline FOG score = 10. Age between 40 and 80 years Stable treatment regimen with no medication changes within the past 1 month. Receiving a stable dose of levodopa for the past 4 weeks. Provision of written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Severe psychiatric disorders, such as schizophrenia or bipolar disorder Severe cardiovascular diseases, including uncontrolled heart failure. Use of other central nervous system stimulants Severe cognitive impairment, defined as MMSE < 24. Development of severe adverse events requiring discontinuation of the study medication History of hypersensitivity to psychostimulants. Presence of comorbid conditions that may impair gait, such as stroke or significant osteoarthritis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of freezing of gait (FOG score) as measured by the FOG Questionnaire;. Timepoint: The FOG questionnaire will be completed at baseline and again 6 weeks after initiating the study medication. Method of measurement: FOG questioner. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactneda sheikhinia
Iran University of Medical Sciences
Outcome results
None listed