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IRCT20251122068081N2 IRCT 2025-12-20 Iran University of Medical Sciences Evaluation of the effect of 4-aminopyridine on freezing of gait in patients with Parkinson’s disease Determining and comparing the effect of 4-aminopyridine 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/87906 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), 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: 4-Aminopyridine 10 mg (Dalfyra®, Arvand Pharmed) is prescribed at a dose of one tablet every 12 hours for 6 weeks. Each patient is provided with 84 tablets of Dalfyra® 10 mg to be taken over a period of 6 weeks, at a dosage of two tablets per day, administered at 12-hour intervals. Intervention 2: Control group :Placebo(vit b1300) taken Q12 h for 6 weeks. Each patient is provided with 84 tablets of Placebo over a period of 6 weeks, at a dosage of two tablets per day, administered at 12-hour intervals. 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: You may request an appointment by visiting the Movement Disorders Clinic at Rasoul Akram Hospital or by emailing: fahmoh2013@gmail.com 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 Fahimeh mohaghegh
Hazrat Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6435 1000 fahmoh2013@gmail.com Iran University of Medical Sciences scientific Fahimeh mohaghegh
Hazrat Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6435 1000 fahmoh2013@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of idiopathic Parkinson’s disease confirmed by a Parkinson’s disease fellowship-trained neurologist History of experiencing episodes of freezing of gait, with a baseline FOG score ≥ 10 Age between 40 and 80 years Stable treatment regimen with no medication changes during the past month Receiving a stable dose of levodopa for the past 4 weeks Providing written informed consent to participate in the study. 40 years 80 years Both History of hypersensitivity to 4-aminopyridine. History of seizures for any reason. Presence of severe cognitive impairment (MMSE < 24). Presence of another comorbidity that can impair gait, such as stroke or osteoarthritis Occurrence of severe adverse effects requiring discontinuation of the medication. G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: 4-Aminopyridine 10 mg (Dalfyra®, Arvand Pharmed) is prescribed at a dose of one tablet every 12 hours for 6 weeks. Each patient is provided with 84 tablets of Dalfyra® 10 mg to be taken over a period of 6 weeks, at a dosage of two tablets per day, administered at 12-hour intervals. Control group :Placebo(vit b1300) taken Q12 h for 6 weeks. Each patient is provided with 84 tablets of Placebo over a period of 6 weeks, at a dosage of two tablets per day, administered at 12-hour intervals. Severity of freezing of gait (FOG score) as measured by the FOG Questionnaire.(this variable reflects the intensity of FOG episodes and will be used to assess the effect of 4-aminopyridine compared to placebo). Timepoint: questionnaire completed before and after the 6-week treatment. Method of measurement: freezing of gait (FOG )Questionnaire. Iran University of Medical Sciences Approved 2025-08-12 Ethics committee of IRAN University of Medical Sciences Niayesh St, Satarkhan St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)