PARKINSON DISNCT07613112
Longitudinal Natural History Protocol for PRKN- and PINK1-Linked PD
An observational study of PARKINSON DIS, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Parkinson s disease is a neurologic disorder that affects movement. Its cause is unknown, and it usually begins later in life. Gene changes (PRKN and PINK1) can also cause rare types of Parkinson s disease that start at a young age. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- PARKINSON DIS
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2026to 30 May 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There will be a total of up to 50 male or female participants 18- 80 years of age and older in 5 cohorts. Target number of completers for each cohort are listed below: - PD mito-biallelic (PD participants carrying two pathogenic variants in PRKN or PINK1): up to 15 - PD mito-monoallelic (PD participants carrying one pathogenic mono-allelic variant in PRKN and/or PINK1): up to 10 - PD idiopathic: up to 5 - Non-manifesting mito (participants who carry one or two pathogenic variants in PRKN and/or PINK1 but do not have a diagnosis of PD): up to 15 - Healthy controls: up to 5
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- All participants:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female between the ages of 18-80 years old
- Ability of subject to understand and the willingness to sign an informed consent document
- Ability of subject to travel to the NIH Clinical Center
Show all 22Show fewer
- Additional inclusion criteria for each cohort as below:
- PD Mito - Biallelic:
- Established clinical diagnosis of Parkinson's disease
- Two Pathogenic or likely pathogenic variants in PRKN or PINK1
- PD Mito - Monoallelic:
- Established clinical diagnosis of Parkinson's disease
- One Pathogenic or likely pathogenic variant in PRKN and/or PINK1
- Idiopathic Parkinson's Disease (PD):
- Established clinical diagnosis of Parkinson's disease
- Etiology of PD is idiopathic/sporadic based on investigator determination
- Non-manifesting mito:
- One or two pathogenic or likely pathogenic variant in PRKN and/or PINK1
- Lack of clinical diagnosis of Parkinson's disease
- Lack of current or clinically significant neurological disorder (based on investigator determination)
- Healthy Volunteer
- -Lack of current or clinically significant neurological disorder (based on investigator determination)
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- All participants:
- Symptomatic PD syndromes due to drugs (e.g., metoclopramide, flunarizine, neuroleptics), metabolic disorders (e.g., Wilson's disease hypothyroidism), encephalitis, brain lesion, atypical parkinsonism, other monogenic forms of PD (e.g., GBA1, LRRK2, SNCA, VPS35, CHCHD2, DJ1, ATP13A2) other genetic disorders that may cause parkinsonism (e.g., spinocerebellar ataxia, X-linked dystonia parkinsonism)
- Pregnancy at time of study enrollment
- Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment
- Unwilling to allow samples or data to be shared with other researchers or institutions.
Show all 29Show fewer
- NIH staff or family members of study team members
- Healthy Volunteer:
- -Participants who become pregnant during the study will be withdrawn from further study procedures at the time pregnancy is identified.
- Procedural Exclusions:
- Subjects may still be enrolled if they cannot participate in certain procedures due to not meeting the inclusion requirements for that specific procedure. Subjects who meet exclusion criteria for procedures listed below may still undergo the procedure at a later time if the reason of exclusion is no longer present.
- Brain MRI:
- Contraindications to MRI such as a contraindicated non-removable metal device (i.e., pacemaker, defibrillator, insulin pump, metal clips, non-removable jewelry)
- Pregnancy
- Accelerometer:
- -Non ambulatory
- Lumbar puncture procedure:
- PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)
- INR greater than 1.4, thrombocytopenia (<70,000), or abnormal bleeding time or platelet dysfunction
- History of a bleeding disorder
- Use of anticoagulants or antiplatelets
- Pregnancy
- History of headache requiring blood patch after a previous LP
- Needle muscle biopsy:
- PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)
- INR greater than 1.4, thrombocytopenia (<70,000), or abnormal bleeding time or platelet dysfunction
- History of a bleeding disorder
- Use of anticoagulants or antiplatelets
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Longitudinal Natural History Protocol for PRKN- and PINK1-linked PD
Background:
Parkinson s disease is a neurologic disorder that affects movement. Its cause is unknown, and it usually begins later in life. Gene changes (PRKN and PINK1) can also cause rare types of Parkinson s disease that start at a young age. Researchers want to conduct a natural history study to learn more about how genes play a role in Parkinson s disease.
Read more
Objective:
To collect data and biological samples from people with different types of Parkinson s disease.
Eligibility:
People aged 18 to 80 years with either Parkinson s disease or PRKN- and PINK1-linked Parkinson s disease. Healthy volunteers are also needed.
Design:
Participants will have 6 clinic visits over 5 years. Each visit may take 1 to 3 days.
During each visit:
Participants will have a physical exam. The exam will be videotaped.
They will answer questions about their movement, thinking, mood, and sense of smell. The extent of any symptoms of Parkinson s disease will be evaluated: Participants movements may be assessed with a finger tapping test. They may be asked to scratch and sniff different scented strips to identify odors.
They will wear motion sensors on their arms, legs, chest, and back at the clinic. They will wear motion sensor devices on their wrists at home for 1 week.
Blood and urine samples will be collected.
Other tests are optional:
Magnetic resonance imaging (MRI) scan of the brain. Participants will lie on a table that slides into a tube.
Lumbar puncture (spinal tap). A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.
Muscle biopsy. A small sample of tissue will be taken from the leg.
Read the detailed description
Study Description:
This is a longitudinal, observational study that aims to assess progression of clinical features, imaging, and biologic markers of PD in study participants with and without manifest PD who are bi-allelic or mono-allelic carriers of pathogenic variants in the recessively inherited genes PRKN and PINK1 that represent prototypes of mitochondrial- associated PD.
Objectives:
Primary Objective: To characterize the natural history of motor symptoms in PRKN- and PINK1-linked PD.
Secondary Objectives: To comprehensively characterize other clinical features of PRKN- and PINK1-linked PD over time
Tertiary Objectives:
- To characterize structural brain changes over time
- To identify molecular signatures that differ between PRKN and PINK1-associated PD, non-manifesting mutation carriers, wildtype PD, and healthy controls.
- To generate a repository of longitudinal data and samples for future studies aimed at developing targeted therapies.
- To characterize in-home assessment of movements
- To evaluate for mitochondrial changes in the muscle
Endpoints:
Primary Endpoint: Annual change in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Secondary Endpoints:
- Annual change in MDS-UPDRS parts I, II, IV
- Annual change in Montreal Cognitive Assessment (MoCA)
- Annual change in Timed up and go (TUG)
- Annual change in 10-meter walk
- Annual change in 360 degree turn
- Annual change in Unified Dyskinesia Rating Scale (UDysRS)
- Annual change in University of Pennsylvania Smell Identification Test (UPSIT)
- Annual change in REM-Sleep-Behavior Disorder Screening Questionnaire (RBD-SQ)
- Annual change in Questionnaire for Impulsive-Compulsive Disorders (QUIP)
- Annual change in Epworth Sleepiness Scale (ESS)
- Annual change in Geriatric Depression Scale (GDS)
- Annual change in State-Trait Anxiety Inventory (STAI)
- Annual change in Scales for Outcomes in Parkinson s Disease - Autonomic Dysfunction (SCOPA AUT)
- Annual change in 39-item Parkinson s Disease Questionnaire (PDQ-39)- quality of life measurement
- Annual change in Schwab and England Activities of Daily Living (SE-ADL) scale
- Annual change in Hoehn and Yahr scale assessment Tertiary endpoints:
- Annual change of brain MRI measurement of overall brain, striatum and substantia nigra volumes
- Annual change of brain MRI measurement of iron deposition
- Annual change in studies from blood
- Annual change in studies from CSF
- Annual change in studies from urine
- Annual change in Wearable Accelerometry data
- Evidence of mitochondrial cytopathy on muscle biopsy
- Conditions
- PARKINSON DIS
- Keywords
- PINK1, PRKN, PARKINSON
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Lack of current or clinically significant neurological disorder (based on investigator determination). | |
| Non-manifesting mito | participants who carry one or two pathogenic variants in PRKN and/or PINK1 but do not have a diagnosis of PD | |
| PD idiopathic | PD participants with idiopathic PD | |
| PD mito - monoallelic | Monoallelic: PD participants carrying one pathogenic mono-allelic variant in PRKN and/or PINK1 | |
| PD mito - biallelic | Biallelic: PD participants carrying two pathogenic variants in PRKN or PINK1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of progression of motor symptoms across cohorts
Measured by annual change in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Measured: When final patient completes their last visit
Secondary outcomes (16)
Annual change in MDS-UPDRS parts I, II, IV
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Montreal Cognitive Assessment (MoCA)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Timed up and go (TUG)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in 10-meter walk
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in 360 degree turn
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Unified Dyskinesia Rating Scale (UDysRS)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in University of Pennsylvania Smell Identification Test (UPSIT)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in REM-Sleep-Behavior Disorder Screening Questionnaire (RBD-SQ)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Questionnaire for Impulsive-Compulsive Disorders (QUIP)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Epworth Sleepiness Scale (ESS)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Geriatric Depression Scale (GDS)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in State-Trait Anxiety Inventory (STAI)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA AUT)
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in 39-item Parkinson's Disease Questionnaire (PDQ-39) - quality of life measurement
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Schwab and England Activities of Daily Living (SE-ADL) scale
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Annual change in Hoehn and Yahr scale assessment
Characterization of other clinical features of PRKN- and PINK1- linked PD over time
Measured: When final patient completes their last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start11 Nov 2026 (estimated)
- Primary completion30 May 2036 (estimated)
- Study completion30 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra J Ehrlich, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613112
- Sponsor's protocol ID
- 10002619
- Other IDs
- 002619-N
- Status last verified
- 9 Oct 2026
- First submitted
- 28 May 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Natural History Protocol for PRKN- and PINK1-linked PD
- ClinicalTrials.gov ID
- NCT07613112
- Acronym / sponsor ID
- 10002619
- Conditions
- PARKINSON DIS
- Keywords
- PINK1, PRKN, PARKINSON
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 30 May 2036 (estimated)
- Study completion
- 30 May 2036 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Parkinson s disease is a neurologic disorder that affects movement. Its cause is unknown, and it usually begins later in life. Gene changes (PRKN and PINK1) can also cause rare types of Parkinson s disease that start at a young age. Researchers want to conduct a natural history study to learn more about how genes play a role in Parkinson s disease.
Objective:
To collect data and biological samples from people with different types of Parkinson s disease.
Eligibility:
People aged 18 to 80 years with either Parkinson s disease or PRKN- and PINK1-linked Parkinson s disease. Healthy volunteers are also needed.
Design:
Participants will have 6 clinic visits over 5 years. Each visit may take 1 to 3 days.
During each visit:
Participants will have a physical exam. The exam will be videotaped.
They will answer questions about their movement, thinking, mood, and sense of smell. The extent of any symptoms of Parkinson s disease will be evaluated: Participants movements may be assessed with a finger tapping test. They may be asked to scratch and sniff different scented strips to identify odors.
They will wear motion sensors on their arms, legs, chest, and back at the clinic. They will wear motion sensor devices on their wrists at home for 1 week.
Blood and urine samples will be collected.
Other tests are optional:
Magnetic resonance imaging (MRI) scan of the brain. Participants will lie on a table that slides into a tube.
Lumbar puncture (spinal tap). A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.
Muscle biopsy. A small sample of tissue will be taken from the leg.
Detailed description
Study Description:
This is a longitudinal, observational study that aims to assess progression of clinical features, imaging, and biologic markers of PD in study participants with and without manifest PD who are bi-allelic or mono-allelic carriers of pathogenic variants in the recessively inherited genes PRKN and PINK1 that represent prototypes of mitochondrial- associated PD.
Objectives:
Primary Objective: To characterize the natural history of motor symptoms in PRKN- and PINK1-linked PD.
Secondary Objectives: To comprehensively characterize other clinical features of PRKN- and PINK1-linked PD over time
Tertiary Objectives:
- To characterize structural brain changes over time
- To identify molecular signatures that differ between PRKN and PINK1-associated PD, non-manifesting mutation carriers, wildtype PD, and healthy controls.
- To generate a repository of longitudinal data and samples for future studies aimed at developing targeted therapies.
- To characterize in-home assessment of movements
- To evaluate for mitochondrial changes in the muscle
Endpoints:
Primary Endpoint: Annual change in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Secondary Endpoints:
- Annual change in MDS-UPDRS parts I, II, IV
- Annual change in Montreal Cognitive Assessment (MoCA)
- Annual change in Timed up and go (TUG)
- Annual change in 10-meter walk
- Annual change in 360 degree turn
- Annual change in Unified Dyskinesia Rating Scale (UDysRS)
- Annual change in University of Pennsylvania Smell Identification Test (UPSIT)
- Annual change in REM-Sleep-Behavior Disorder Screening Questionnaire (RBD-SQ)
- Annual change in Questionnaire for Impulsive-Compulsive Disorders (QUIP)
- Annual change in Epworth Sleepiness Scale (ESS)
- Annual change in Geriatric Depression Scale (GDS)
- Annual change in State-Trait Anxiety Inventory (STAI)
- Annual change in Scales for Outcomes in Parkinson s Disease - Autonomic Dysfunction (SCOPA AUT)
- Annual change in 39-item Parkinson s Disease Questionnaire (PDQ-39)- quality of life measurement
- Annual change in Schwab and England Activities of Daily Living (SE-ADL) scale
- Annual change in Hoehn and Yahr scale assessment Tertiary endpoints:
- Annual change of brain MRI measurement of overall brain, striatum and substantia nigra volumes
- Annual change of brain MRI measurement of iron deposition
- Annual change in studies from blood
- Annual change in studies from CSF
- Annual change in studies from urine
- Annual change in Wearable Accelerometry data
- Evidence of mitochondrial cytopathy on muscle biopsy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –Lack of current or clinically significant neurological disorder (based on investigator determination). |
| Non-manifesting mito | – | –participants who carry one or two pathogenic variants in PRKN and/or PINK1 but do not have a diagnosis of PD |
| PD idiopathic | – | –PD participants with idiopathic PD |
| PD mito - monoallelic | – | –Monoallelic: PD participants carrying one pathogenic mono-allelic variant in PRKN and/or PINK1 |
| PD mito - biallelic | – | –Biallelic: PD participants carrying two pathogenic variants in PRKN or PINK1 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There will be a total of up to 50 male or female participants 18- 80 years of age and older in 5 cohorts. Target number of completers for each cohort are listed below: - PD mito-biallelic (PD participants carrying two pathogenic variants in PRKN or PINK1): up to 15 - PD mito-monoallelic (PD participants carrying one pathogenic mono-allelic variant in PRKN and/or PINK1): up to 10 - PD idiopathic: up to 5 - Non-manifesting mito (participants who carry one or two pathogenic variants in PRKN and/or PINK1 but do not have a diagnosis of PD): up to 15 - Healthy controls: up to 5
Key inclusion criteria (22 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female between the ages of 18-80 years old
- Ability of subject to understand and the willingness to sign an informed consent document
- Ability of subject to travel to the NIH Clinical Center
Key exclusion criteria (29 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Symptomatic PD syndromes due to drugs (e.g., metoclopramide, flunarizine, neuroleptics), metabolic disorders (e.g., Wilson's disease hypothyroidism), encephalitis, brain lesion, atypical parkinsonism, other monogenic forms of PD (e.g., GBA1, LRRK2, SNCA, VPS35, CHCHD2, DJ1, ATP13A2) other genetic disorders that may cause parkinsonism (e.g., spinocerebellar ataxia, X-linked dystonia parkinsonism)
- Pregnancy at time of study enrollment
- Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment
- Unwilling to allow samples or data to be shared with other researchers or institutions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimation of progression of motor symptoms across cohorts
Time frame: When final patient completes their last visit
Measured by annual change in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
16 secondary outcomes
Annual change in MDS-UPDRS parts I, II, IV
Time frame: When final patient completes their last visit
Annual change in Montreal Cognitive Assessment (MoCA)
Time frame: When final patient completes their last visit
Annual change in Timed up and go (TUG)
Time frame: When final patient completes their last visit
Annual change in 10-meter walk
Time frame: When final patient completes their last visit
Annual change in 360 degree turn
Time frame: When final patient completes their last visit
Annual change in Unified Dyskinesia Rating Scale (UDysRS)
Time frame: When final patient completes their last visit
Annual change in University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: When final patient completes their last visit
Annual change in REM-Sleep-Behavior Disorder Screening Questionnaire (RBD-SQ)
Time frame: When final patient completes their last visit
Annual change in Questionnaire for Impulsive-Compulsive Disorders (QUIP)
Time frame: When final patient completes their last visit
Annual change in Epworth Sleepiness Scale (ESS)
Time frame: When final patient completes their last visit
Annual change in Geriatric Depression Scale (GDS)
Time frame: When final patient completes their last visit
Annual change in State-Trait Anxiety Inventory (STAI)
Time frame: When final patient completes their last visit
Annual change in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA AUT)
Time frame: When final patient completes their last visit
Annual change in 39-item Parkinson's Disease Questionnaire (PDQ-39) - quality of life measurement
Time frame: When final patient completes their last visit
Annual change in Schwab and England Activities of Daily Living (SE-ADL) scale
Time frame: When final patient completes their last visit
Annual change in Hoehn and Yahr scale assessment
Time frame: When final patient completes their last visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Debra J Ehrlich, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DIS, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oday K Halhouli, M.D. ((301) 402-7969, oday.halhouli@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of progression of motor symptoms across cohorts (time frame: When final patient completes their last visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.