Skip to content

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251122068081N2
Enrollment
90
Registered
2025-12-20
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease. Parkinson's disease

Interventions

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 Dalfy

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh mohaghegh

Iran University of Medical Sciences

fahmoh2013@gmail.com+98 21 6435 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026