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
Evaluation of the Effect of Lisdexamfetamine on Freezing of Gait in Patients with Parkinson’s Disease”
Design
Randomized, controlled clinical trial with parallel groups, single-blind
Settings and conduct
A total of 90 patients with idiopathic Parkinson’s disease who attend the Movement Disorders Clinic of Rasoul Akram Hospital and experience varying degrees of freezing of gait (FOG) during the ON phase will be included.The sampling method will be convenience sampling, and patients will be randomly assigned to two study groups.completion of the FOG questionnaire before and after the intervention will be performed by a movement disorders fellowship.
Participants/Inclusion and exclusion criteria
1.Diagnosis of idiopathic Parkinson’s disease confirmed by a movement disorders (Parkinson’s) fellowship-trained neurologist.2.History of freezing of gait episodes, with a baseline FOG score ≥ 10.3.Age between 40 and 80 years.
4.Stable treatment regimen with no medication changes within the past 1 month.5.Receiving a stable dose of levodopa for the past 4 weeks.
6.Provision of written informed consent to participate in the study.
1.Severe psychiatric disorders2.Severe cardiovascular diseases 3.Use of other central nervous system stimulants.4.Severe cognitive impairment, defined as MMSE < 24.5.Development of severe adverse events requiring discontinuation of the study medication.6.History of hypersensitivity to psychostimulants.
Intervention groups
Group 1 (45 patients): will receive Lisdexamfetamine 30 mg once daily for a duration of 6 weeks. Outcome questionnaires will be completed again at the end of the 6-week treatment period. Group 2 (45 patients): will receive a placebo for 6 weeks, and the same questionnaires will be completed before and after the 6-week placebo period.
Main outcome variables
severity of freezing of gait (FOG score);Change in FOG score after 6 weeks of
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251122068081N1
Registration date:2025-12-16, 1404/09/25
Registration timing:prospective
Last update:2025-12-16, 1404/09/25
Update count:0
Registration date
2025-12-16, 1404/09/25
Registrant information
Name
neda sheikhinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 0667
Email address
neda.sheikhinia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the Effect of Lisdexamfetamine on Freezing of Gait in Patients with Parkinson’s Disease
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of iran University of Medical Sciences
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information related to the primary outcome can be shared
When the data will become available and for how long
Access period starts 6 months after the publication of results
To whom data/document is available
Researchers affiliated with academic and scientific institutions
Under which criteria data/document could be used
Use of data for completing clinical studies
From where data/document is obtainable
Rasoul Akram Hospital
What processes are involved for a request to access data/document
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