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IRCT20251122068081N1 IRCT 2025-12-16 Iran University of Medical Sciences Evaluation of the Effect of Lisdexamfetamine on Freezing of Gait in Patients with Parkinson’s Disease Evaluation of the Effect of Lisdexamfetamine versus Placebo on the Severity and Frequency of Freezing of Gait (FOG) in the ON Phase in Patients with Parkinson’s Disease 2025-12-22 anticipated 90 Complete https://irct.ir/trial/87911 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: placebo group using block randomization with variable block sizes of 4 and 6 to ensure balanced allocation. Individual randomization will be applied, and stratified randomization based on baseline FOG severity (FOG score 10–20 vs. >20) will be used to minimize imbalance between groups.The randomization sequence will be generated by an independent statistician using IBM SPSS. Allocation assignments will be placed in sealed, opaque, sequentially numbered envelopes, which will be opened by the study coordinator only after enrollment and consent.The medication and placebo will be prepared in identical packaging so that only the participant remains blinded to group allocation. Investigators and outcome assessors will be aware of the assigned intervention; therefore, the study will follow a single-blind (participant-blind) design, Blinding description: This study is designed as a single-blind (Single-Blind) trial, meaning that only the participants are unaware of their assignment to either the 4-aminopyridine or placebo group. Participants: Blinded; the study drug and placebo are provided in identical packaging to prevent any discernible differences. Principal investigator and treating physicians: Not blinded, due to the need for monitoring potential drug-related adverse effects. Nurses, physiotherapists, and pharmacist: Not blinded; they are responsible for administering the study medication or patient care, but the allocation information is not disclosed to the participants. Outcome assessors and data collectors: Not blinded, but they follow standardized protocols to minimize bias. Data Safety and Monitoring Committee (DSMC): Not blinded, as they are responsible for reviewing patient safety. Data analysts and manuscript writers: Analysts remain blinded until the completion of the analysis, with groups coded as A and B. 2-3 Parkinson's disease. Intervention 1: Intervention group: Lisdexamfetamine 30 mg, taken once daily for 6 weeks. Intervention 2: Control group: placebo taken once daily for 6. Yes - There is a plan to make this available What will be shared: Information related to the primary outcome can be shared When: Access period starts 6 months after the publication of results To whom: Researchers affiliated with academic and scientific institutions Conditions: Use of data for completing clinical studies Where to obtain: Rasoul Akram Hospital How to obtain: Upon review of the researcher’s request and submission of sufficient documentation about their study and the rationale for using the data, access may be granted Comments:
public neda sheikhinia
Hazrat Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6435 1000 neda.sheikhinia@yahoo.com Iran University of Medical Sciences scientific neda sheikhinia
Hazrat Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6435 1000 neda.sheikhinia@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 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. 40 years 80 years Both 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. G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: Lisdexamfetamine 30 mg, taken once daily for 6 weeks Control group: placebo taken once daily for 6 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. Iran University of Medical Sciences Approved 2025-10-13 Ethics committee of iran University of Medical Sciences Hazrat Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)