Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT01652534
Eligibility Criteria:
Inclusion Criteria:
1. Subjects with idiopathic PD as determined by UK brain bank diagnostic criteria
2. H\&Y stage 2.5-3
3. Presence of freezing of gait (FOG) as determined by UPDRS Part I score \> 2
4. Ability to walk for 2 minutes in the ON and OFF state
5. Stable regimen of PD medications for 30 days prior to screening
6. Ability to comply with the study procedures
7. If female, be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.10 for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
8. Willing and able to provide informed consent.
Exclusion Criteria:
1. Presence of other co morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
2. Presence of freezing of gait (FOG) ONLY in medications ON state
3. Presence of freezing of gait (FOG) ONLY in medications OFF state
4. Presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MoCA) \<20
5. Presence of clinically significant depression as determined by geriatric depression scale (GDS)- 15\>5
6. Presence of clinically significant hallucinations
7. Inability to sign informed consent
8. Participation in the physical therapy aimed at management of PD for the duration of the study (PT for orthopedic issues will be allowed)
9. Contraindications for use of Amantadine ( prior history of allergic reaction, history of known renal insufficiency with Cr \> 2)
10. If female, be pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01652534
Study Brief:
Protocol Section:
NCT01652534