Ataxia TelangiectasiaPhase 1/2NCT07215416
Safety and Efficacy of Mutation-targeted Precision Genetic Therapy for Ataxia-Telangiectasia (A-T)
A Phase 1/2 study testing Antisense oligonucleotide targeting the ATM gene in people with Ataxia Telangiectasia, run by Timothy Yu at 1 site in United States.
Trial summary
This project aims to evaluate the safety and efficacy of precision genetic therapy for patients with Ataxia-telangiectasia (A-T), a rare neurodegenerative disease caused by mutations in the ATM gene. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Ataxia Telangiectasia
- What is being tested?
- Antisense oligonucleotide targeting the ATM gene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Dec 2036
- Phase
- Phase 1/2
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Who can take part:
- People with classic A-T confirmed by genetic testing
- Must have a specific ATM gene change (c.7865C>T)
- Must also have another ATM change that causes A-T
- Who cannot take part:
- People with health problems that make lumbar puncture unsafe:
Show all 15Show fewer
- Blood clotting or bleeding problems
- Brain conditions raising pressure inside the head
- Serious heart or breathing problems
- Infection near the lower back
- Other things doctors will check:
- Overall health and stability
- Any medicines that might cause problems
- Past difficulties with lumbar punctures
- Any other safety concerns
Who cannot join
None listed.
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, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Arya Newington, 617-919-7499, arya.newington@childrens.harvard.edu
About this study
Official title: A Phase 1/2 Study of Antisense Oligonucleotide Therapy for Treatment of Ataxia-Telangiectasia
This project aims to evaluate the safety and efficacy of precision genetic therapy for patients with Ataxia-telangiectasia (A-T), a rare neurodegenerative disease caused by mutations in the ATM gene. The investigators will conduct a clinical trial to study the safety and efficacy of intrathecal administration of atipeksen, a targeted genetic therapy that restores ATM gene function in A-T individuals bearing the recurrent ATM c.7865C>T variant. The aim of this study is to delay or forestall progression of neurologic symptoms in A-T and improving quality of life. Success will provide an empirical foundation for advancing additional precision genetic therapies for A-T and other neurodegenerative conditions.
Read the detailed description
The goal of this protocol is to study the safety and efficacy of the investigational drug atipeksen, a mutation-specific antisense oligonucleotide (ASO), in individuals with ataxia telangiectasia (A-T). The first objective is to evaluate the safety of therapy with atipeksen, a 22-nucleotide oligonucleotide designed to ameliorate the effects of mis-splicing caused by a mutation in the ATM gene(NM_000051.3), c.7865C>T (p.Ala2622Val), when administered via intrathecal injection. The second objective is to determine if administration of intrathecal atipeksen can reduce or stabilize neurological decline using clinical and physiological biomarkers. The primary endpoint will be serial clinical neurologic assessments using the Ataxia-Telangiectasia Neurological Examination Toolkit (A-T NEST) and a structured version of the Ataxia-Telangiectasia Clinical Global Impression of Change (A-T CGI). Secondary endpoints will include videotaped clinical neurological examinations, movement pattern analyses using wearable actigraphy, and standard scales administered by PT, OT, and neuropsychology. Exploratory endpoints include serial brain imaging with volumetric analyses, neurofilament light chain, alpha-fetoprotein, and growth parameters.
- Conditions
- Ataxia Telangiectasia
- Being tested
- Antisense oligonucleotide targeting the ATM gene
- Keywords
- Ataxia Telangiectasia, A-T, ASO, Intrathecal administration, ATM, ATIPEKSEN
- Medical subject headings
- Ataxia Telangiectasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antisense oligonucleotide targeting the ATM geneDrug
Atipeksen is a fully modified PS-2'MOE splice-switching antisense oligonucleotide that is designed to restore normal splicing patterns in patients with the ATM c.7865C>T mutation.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1/2 Study of Antisense Oligonucleotide Therapy for Treatment of Ataxia - Telangiectasia | Experimental | Individuals with genetically confirmed, classic ataxia telangiectasia with at least one copy of the ASO-amenable ATM variant NM_000051.3:c.7865C>T;p.Ala2622Val, will receive the ASO at the same dose. Receives: Drug: Antisense oligonucleotide targeting the ATM gene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological function as measured by the AT-NEST scale
The Ataxia-Telangiectasia Neurological Examination Toolkit (AT-NEST) is a test designed specifically for people with Ataxia-Telangiectasia (A-T). It helps doctors and researchers understand how the brain and nerves are working. The test looks at six main areas:
- Communication
- Eye movements Ataxia (problems with balance and coordination)
- Movement disorders
- Muscle strength (Power)
- Nerve function (Neuropathy) These six areas make up the "pure neuro" score, which ranges from 0 (lowest) to 100 (highest). The test also includes growth and nutrition. When these are added to the six main areas, a total "neuro-related" score is calculated, with a maximum of 114. Higher scores mean better overall performance.This test is not painful and is carried out by trained specialists who will guide you through each step.
Measured: At Baseline and every 12 weeks up to ten years
Ataxia-Telangiectasia Structured Clinical Global Impression of Change (A-T CGI)
The Ataxia-Telangiectasia Clinical Global Impression of Change (AT-CGI) is a tool used to track how A-T progresses over time. It looks at five main areas of the disease:
Ataxia (balance and coordination problems) Dysarthria (difficulty speaking) Repetitive movements / Dysmetria (trouble controlling movements) Movement disorders Eye movements
Each area is scored from 0 to 4, for a total of 20 points. Higher scores mean more severe symptoms, while lower scores indicate better function.
Measured: At Baseline and every 12 weeks up to ten years
Secondary outcomes (8)
Motor performance as measured by the Bruininks-Oseretsky Test of Motor Proficiency 2nd edition
The Bruininks-Oseretsky Test of Motor Proficiency 2nd edition (BOT-2) is a simple way for therapists to check how your child is developing movement skills. It looks at:
- Small hand and finger movements (fine motor)
- How quickly and accurately hands are used (dexterity)
- Big movements like running or jumping (gross motor)
- How well the body works together (coordination) During the test, the child does different activities, and each one is scored. These scores are added up to give both an overall score (out of 200 points) and separate scores for each skill area. The results are then compared to what is typical for children of the same age.
Measured: Baseline and every 6 months up to 10 years
Performance and goal satisfaction as measured by the Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) is a test done by an occupational therapist to understand what daily activities are most important to a person and how well they feel they can do them. During the test, the person picks up to five activities they find difficult or want to improve. For each activity, they rate:
- How well they can do it
- How satisfied they are with their performance Both scores range from 1 to 10 (higher numbers mean better performance or more satisfaction). The scores are then averaged to see overall progress. The main goal is to track improvements over time, especially before and after a therapy or intervention.
Measured: Baseline and every 6 months up to 10 years
Performance in activities of daily living as measured by the Pediatric Evaluation of Disability Inventory Computer Adaptive Test
The Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) is a questionnaire filled out by parents or caregivers. It helps us understand how a child is doing in everyday life. It looks at four areas:
- Daily activities (like eating, dressing, and personal care)
- Mobility (how a child moves around)
- Social/cognitive (how a child plays, communicates, and learns)
- Responsibility (how much a child can manage tasks at home or in the community) The test is "adaptive," meaning the questions change depending on how you answer, so it fits your child's abilities. Each area gets a score from 0 to 100, with higher scores meaning better functional ability.
Measured: Baseline and every 6 months up to 10 years
Visual-motor function as measured by the Beery-Buktenica Developmental Test of Visual Motor Integration
The Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery-VMI) is a test often given by occupational therapists to see how well a child's eyes and hands work together. During the test, the child copies shapes and designs that get harder as the test goes on. Sometimes the child may also be asked to find differences between pictures or match patterns. The results show:
- A standard score with a range of 45 to 155; higher scores indicate a better performance
- A percentile score, which shows what percentage of children the same age scored lower.
This helps parents and therapists see how the child's coordination and fine motor skills are compared to others their age.
Measured: Baseline and every 6 months up to 10 years
Neurodevelopmental function, as measured by the Leiter International Performance, third edition
The Leiter International Performance Scale-3 (Leiter-3) is a test that measures thinking and problem-solving skills. It is especially helpful for children or adults who have speech, language, or learning difficulties, or for those who do not speak English. The test looks at areas such as:
- Problem-solving and reasoning
- Attention and memory Visual and spatial skills (understanding shapes, patterns, and space) The results include an IQ score (higher scores mean stronger skills). Subtest scores range from 0 to 20 and composite scores range from 30 to 170; higher scores indicate a better outcome.
This helps show how a person's thinking skills compare to others their age.
Measured: Baseline and yearly up to 10 years
Neurodevelopmental function, as measured Wechsler Intelligence Scale for Children, fifth edition
he Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V) is a test that measures different areas of a child's thinking and learning. It looks at skills such as:
- Understanding and using language (verbal comprehension)
- Solving puzzles and understanding visual information (visual-spatial)
- Problem-solving and reasoning (fluid reasoning)
- Remembering information (working memory)
- How quickly the brain processes information (processing speed) Subtests have scaled scores with a range of 1 to 19 and composites have standard scores with a range from 45 to 155; higher scores indicate a better outcome.
The test gives a Full Scale IQ (FSIQ) score, which shows a child's overall level of thinking skills. Higher scores mean stronger abilities.
Measured: Baseline and yearly up to 10 years
Neurodevelopmental function, as measured by the Vineland Adaptive Behavior Scale
The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is a test that measures how a child or adult manages everyday life skills, also called adaptive behaviors.It looks at areas such as:
- Communication (understanding and using language)
- Daily living skills (self-care, getting dressed, eating)
- Socialization (interacting with others)
- Motor skills (movement and coordination) Subtests are calculated as v-Scale scores with a possible range of 1 to 19. Composite scores are Standard Scores with a range of 20 to 140. Higher scores indicate a better outcome Growth scale values (GSVs) describe the participant's absolute level of performance on a test. Range is 10 to 220. Higher scores indicate better performance The results are turned into scores that show how well a person is functioning in daily life. Higher scores mean stronger everyday skills.
Measured: Baseline and yearly up to 10 years
Motor performance through digital wearable actigraphs
Digital actigraphs are small motion sensors that track how a person moves during daily life. They are often used in people with movement disorders, like ataxia and ataxia-telangiectasia.
In this study, participants will wear one sensor on the wrist and one on the ankle for one week at a time. The information collected will show how a person moves during everyday activities. These results will then be compared to others with ataxia-telangiectasia who are not receiving treatment.
Measured: Baseline and every 12 weeks up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study startAug 2026 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ataxia TelangiectasiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Timothy Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Yu, Boston Children's Hospital
- Investigators
- Timothy Yu, MD, PhD, Study director, Boston Childrens HostpitalChristelle Achkar, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215416
- Sponsor's protocol ID
- IRB P00050954
- Status last verified
- May 2026
- First submitted
- 10 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim J, Woo S, de Gusmao CM, Zhao B, Chin DH, DiDonato RL, Nguyen MA, Nakayama T, Hu CA, Soucy A, Kuniholm A, Thornton JK, Riccardi O, Friedman DA, El Achkar CM, Dash Z, Cornelissen L, Donado C, Faour KNW, Bush LW, Suslovitch V, Lentucci C, Park PJ, Lee EA, Patterson A, Philippakis AA, Margus B, Berde CB, Yu TW. A framework for individualized splice-switching oligonucleotide therapy. Nature. 2023 Jul;619(7971):828-836. doi: 10.1038/s41586-023-06277-0. Epub 2023 Jul 12.
PubMed 37438524
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Antisense Oligonucleotide Therapy for Treatment of Ataxia-Telangiectasia
- ClinicalTrials.gov ID
- NCT07215416
- Acronym / sponsor ID
- IRB P00050954
- Conditions
- Ataxia Telangiectasia
- Keywords
- Ataxia Telangiectasia, A-T, ASO, Intrathecal administration, ATM, ATIPEKSEN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Timothy YuUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 10 Oct 2025 (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.
This project aims to evaluate the safety and efficacy of precision genetic therapy for patients with Ataxia-telangiectasia (A-T), a rare neurodegenerative disease caused by mutations in the ATM gene. The investigators will conduct a clinical trial to study the safety and efficacy of intrathecal administration of atipeksen, a targeted genetic therapy that restores ATM gene function in A-T individuals bearing the recurrent ATM c.7865C>T variant. The aim of this study is to delay or forestall progression of neurologic symptoms in A-T and improving quality of life. Success will provide an empirical foundation for advancing additional precision genetic therapies for A-T and other neurodegenerative conditions.
Detailed description
The goal of this protocol is to study the safety and efficacy of the investigational drug atipeksen, a mutation-specific antisense oligonucleotide (ASO), in individuals with ataxia telangiectasia (A-T). The first objective is to evaluate the safety of therapy with atipeksen, a 22-nucleotide oligonucleotide designed to ameliorate the effects of mis-splicing caused by a mutation in the ATM gene(NM_000051.3), c.7865C>T (p.Ala2622Val), when administered via intrathecal injection. The second objective is to determine if administration of intrathecal atipeksen can reduce or stabilize neurological decline using clinical and physiological biomarkers. The primary endpoint will be serial clinical neurologic assessments using the Ataxia-Telangiectasia Neurological Examination Toolkit (A-T NEST) and a structured version of the Ataxia-Telangiectasia Clinical Global Impression of Change (A-T CGI). Secondary endpoints will include videotaped clinical neurological examinations, movement pattern analyses using wearable actigraphy, and standard scales administered by PT, OT, and neuropsychology. Exploratory endpoints include serial brain imaging with volumetric analyses, neurofilament light chain, alpha-fetoprotein, and growth parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1/2 Study of Antisense Oligonucleotide Therapy for Treatment of Ataxia - Telangiectasia | Experimental | Drug: Antisense oligonucleotide targeting the ATM geneIndividuals with genetically confirmed, classic ataxia telangiectasia with at least one copy of the ASO-amenable ATM variant NM_000051.3:c.7865C>T;p.Ala2622Val, will receive the ASO at the same dose. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- People with classic A-T confirmed by genetic testing
- Must have a specific ATM gene change (c.7865C>T)
- Must also have another ATM change that causes A-T
- Blood clotting or bleeding problems
- Brain conditions raising pressure inside the head
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antisense oligonucleotide targeting the ATM geneAtipeksen is a fully modified PS-2'MOE splice-switching antisense oligonucleotide that is designed to restore normal splicing patterns in patients with the ATM c.7865C>T mutation. | Drug | Phase 1/2 Study of Antisense Oligonucleotide Therapy for Treatment of Ataxia - Telangiectasia |
Primary outcome
Neurological function as measured by the AT-NEST scale
Time frame: At Baseline and every 12 weeks up to ten years
The Ataxia-Telangiectasia Neurological Examination Toolkit (AT-NEST) is a test designed specifically for people with Ataxia-Telangiectasia (A-T). It helps doctors and researchers understand how the brain and nerves are working. The test looks at six main areas: * Communication * Eye movements Ataxia (problems with balance and coordination) * Movement disorders * Muscle strength (Power) * Nerve function (Neuropathy) These six areas make up the "pure neuro" score, which ranges from 0 (lowest) to 100 (highest). The test also includes growth and nutrition. When these are added to the six main areas, a total "neuro-related" score is calculated, with a maximum of 114. Higher scores mean better overall performance.This test is not painful and is carried out by trained specialists who will guide you through each step.
Ataxia-Telangiectasia Structured Clinical Global Impression of Change (A-T CGI)
Time frame: At Baseline and every 12 weeks up to ten years
The Ataxia-Telangiectasia Clinical Global Impression of Change (AT-CGI) is a tool used to track how A-T progresses over time. It looks at five main areas of the disease: Ataxia (balance and coordination problems) Dysarthria (difficulty speaking) Repetitive movements / Dysmetria (trouble controlling movements) Movement disorders Eye movements Each area is scored from 0 to 4, for a total of 20 points. Higher scores mean more severe symptoms, while lower scores indicate better function.
8 secondary outcomes
Motor performance as measured by the Bruininks-Oseretsky Test of Motor Proficiency 2nd edition
Time frame: Baseline and every 6 months up to 10 years
Performance and goal satisfaction as measured by the Canadian Occupational Performance Measure (COPM)
Time frame: Baseline and every 6 months up to 10 years
Performance in activities of daily living as measured by the Pediatric Evaluation of Disability Inventory Computer Adaptive Test
Time frame: Baseline and every 6 months up to 10 years
Visual-motor function as measured by the Beery-Buktenica Developmental Test of Visual Motor Integration
Time frame: Baseline and every 6 months up to 10 years
Neurodevelopmental function, as measured by the Leiter International Performance, third edition
Time frame: Baseline and yearly up to 10 years
Neurodevelopmental function, as measured Wechsler Intelligence Scale for Children, fifth edition
Time frame: Baseline and yearly up to 10 years
Neurodevelopmental function, as measured by the Vineland Adaptive Behavior Scale
Time frame: Baseline and yearly up to 10 years
Motor performance through digital wearable actigraphs
Time frame: Baseline and every 12 weeks up to 10 years
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 28 May 2026.
- Background: PubMed 37438524Kim J, Woo S, de Gusmao CM, Zhao B, Chin DH, DiDonato RL, Nguyen MA, Nakayama T, Hu CA, Soucy A, Kuniholm A, Thornton JK, Riccardi O, Friedman DA, El Achkar CM, Dash Z, Cornelissen L, Donado C, Faour KNW, Bush LW, Suslovitch V, Lentucci C, Park PJ, Lee EA, Patterson A, Philippakis AA, Margus B, Berde CB, Yu TW. A framework for individualized splice-switching oligonucleotide therapy. Nature. 2023 Jul;619(7971):828-836. doi: 10.1038/s41586-023-06277-0. Epub 2023 Jul 12.
- 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.
Timothy Yu, MD, PhD study director
Boston Childrens Hostpital
Christelle Achkar, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Antisense oligonucleotide targeting the ATM gene in people with Ataxia Telangiectasia, run by Timothy Yu 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 15 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 28 May 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Arya Newington (617-919-7499, Arya.Newingham@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological function as measured by the AT-NEST scale (time frame: At Baseline and every 12 weeks up to ten years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07215416, which also lists 1 linked publication.
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 28 May 2026.