No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
127 (estimated)
Sponsor
AskBio Inc · Industry
Who this trial is looking for
This trial is looking for adults aged 45-75 with moderate Parkinson's disease. Participants will receive a treatment involving a surgical procedure and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 45 and 75 years old.
I have been diagnosed with Parkinson's disease in the past 4-10 years.
I experience slowness of movement and at least one other symptom.
I have motor fluctuations as measured by a diary.
I have been stable on my anti-parkinsonian medications for at least 4 weeks.
I respond to levodopa therapy.
You may not be able to join if
I have a medical, genetic, or neurological condition that may explain my symptoms.
I have significant heart or blood vessel problems.
I have significant cognitive issues or severe depression/anxiety.
I have a history of psychosis or impulse control disorders.
I have had cancer, except for treated skin cancers.
I have conditions that could affect my safety during surgery.
I cannot have an MRI or use gadolinium contrast agents.
I have had brain surgery before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
Age
1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
1. Presence of bradykines…
Inclusion Criteria:
Age
1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
1. Presence of bradykinesia PLUS any of the following:
* Rigidity
* Rest tremor
* Postural instability
2. Presence of motor fluctuations as measured by the PD Motor Diary
3. Stable anti-parkinsonian medication regimen for \>/= 4 weeks prior to screening
4. Must demonstrate responsiveness to levodopa therapy
Exclusion Criteria:
* Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
* Presence or history of significant vascular and/or cardiovascular disease
* Presence of significant cognitive impairment, poorly controlled depression/anxiety
* Presence or history of psychosis or impulse control disorder
* History of malignancy other than treated cutaneous squamous or basal cell carcinomas
* Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
* Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
* Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
* Chronic immunosuppressive therapy
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.