Huntington DiseasePost-MIGHDNCT06194006
Long Term Follow-up Grafted Huntington's Disease Patients
A study testing Follow-up in people with Huntington Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Long-term follow-up of Huntington's disease patients treated with intrastriatal allografts is essential to assess the benefit/risk ratio of grafts as well as their effectiveness. Indeed, some patients are likely to develop adverse effects and the impact of alloimmunisation phenomena remains to be explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Jan 2034
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients transplanted under the MIG-HD protocol
- Information and informed consent from patients or their representative
- Affiliation with a social security scheme or beneficiary
Who cannot join
- Patient under AME
- Patient unable to express consent and not subject to legal protection
- Knowned pregnancy or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne-Catherine BACHOUD-LEVI, MD, PhD contact
France1 site
Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor
Créteil, 94010
About this study
Official title: Long-term Follow-up of Huntington's Disease Patients Treated With Intrastriatal Fetal Neuron Allograft
Long-term follow-up of Huntington's disease patients treated with intrastriatal allografts is essential to assess the benefit/risk ratio of grafts as well as their effectiveness. Indeed, some patients are likely to develop adverse effects and the impact of alloimmunisation phenomena remains to be explored.
Read the detailed description
The aim is to create a specific cohort of transplant patients, to homogenise their follow-up methods, to collect all the patient data (medical, paramedical, imaging, biological) acquired from the end of their participation in MIG-HD'study (Foetal Striatal allografting in Huntington's disease: a multicentre, randomised, delayed start, phase 2 open-label cell therapy trial) until the last possible follow-up of the last patient in the study
- Conditions
- Huntington Disease
- Being tested
- Follow-up
- Keywords
- Grafted patients, Long term follow-up
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Follow-up grafted patients as long as their condition allows
| Study group | Role | What they receive |
|---|---|---|
| Long term follow-up | Other | * Formalized and standardized follow-up
* Retrospective data collection
* Biological collections
* Biological collections's centralisation Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of the Unified Huntington's Disease Rating Scale (UHDRS) motor score
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Progression of the Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP) motor score
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Secondary outcomes (12)
Slopes comparison of neurological scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Slopes comparison of cognitive scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Slopes comparison of psychiatric scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Slopes comparison of neuropsychologic scores (Mattis Dementia Rating Scale/Trail Making test/Hopkins Verbal Learning Test/Categorical fluency/Sign barrier test/Montgomery-Åsberg Depression Rating Scale (MADRS)) before and after transplantation
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Comparison of the clinical evolution (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) of transplanted patients with that of non-transplanted patients in the BioHD cohort
Grafted patients and cohort patients (BIOHD)
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Events and adverse reactions recording since the transplantation
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Research and identification of anti-MHC Ab from samples acquired under the MIG-HD and Post-MIGHD protocols as well as in care
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Correlation between graft activity measured by imaging and patient performance
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Correlation between post-mortem observations of the brains of deceased patients and measurements obtained by MRI and PET-SCAN in studies MIG-HD and BioHD
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Correlation between post-mortem brain observations and patient performance before death
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Analysis of brains collected as part of MIG-HD and POST-MIGHD i) to quantify neuropathological lesions ii) to search for markers of inflammatory reactions
For all patients whose brains have been recovered
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Research into predictive factors (relationships between fetal haplotypes, patient haplotypes and appearance of alloimmunization phenomena) of the evolution of transplanted patients
For each patient
Measured: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2034 (estimated)
- Study completion1 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Catherine BACHOUD-LEVI, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194006
- Sponsor's protocol ID
- K140601J
- Other IDs
- 2018-A02569-46
- Acronym
- Post-MIGHD
- Status last verified
- May 2023
- First submitted
- 9 Mar 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Huntington's Disease Patients Treated With Intrastriatal Fetal Neuron Allograft
- ClinicalTrials.gov ID
- NCT06194006
- Acronym / sponsor ID
- Post-MIGHD / K140601J
- Conditions
- Huntington Disease
- Keywords
- Grafted patients, Long term follow-up
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2034 (estimated)
- Study completion
- 1 Jan 2034 (estimated)
- First posted
- 8 Jan 2024 (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.
Long-term follow-up of Huntington's disease patients treated with intrastriatal allografts is essential to assess the benefit/risk ratio of grafts as well as their effectiveness. Indeed, some patients are likely to develop adverse effects and the impact of alloimmunisation phenomena remains to be explored.
Detailed description
The aim is to create a specific cohort of transplant patients, to homogenise their follow-up methods, to collect all the patient data (medical, paramedical, imaging, biological) acquired from the end of their participation in MIG-HD'study (Foetal Striatal allografting in Huntington's disease: a multicentre, randomised, delayed start, phase 2 open-label cell therapy trial) until the last possible follow-up of the last patient in the study
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long term follow-up | Other | Other: Follow-up* Formalized and standardized follow-up * Retrospective data collection * Biological collections * Biological collections's centralisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients transplanted under the MIG-HD protocol
- Information and informed consent from patients or their representative
- Affiliation with a social security scheme or beneficiary
Key exclusion criteria (3 listed)
- Patient under AME
- Patient unable to express consent and not subject to legal protection
- Knowned pregnancy or breastfeeding woman
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 |
|---|---|---|
| Follow-upFollow-up grafted patients as long as their condition allows | Other | Long term follow-up |
Primary outcome
Progression of the Unified Huntington's Disease Rating Scale (UHDRS) motor score
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
For each patient
Progression of the Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP) motor score
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
For each patient
12 secondary outcomes
Slopes comparison of neurological scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Slopes comparison of cognitive scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Slopes comparison of psychiatric scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Slopes comparison of neuropsychologic scores (Mattis Dementia Rating Scale/Trail Making test/Hopkins Verbal Learning Test/Categorical fluency/Sign barrier test/Montgomery-Åsberg Depression Rating Scale (MADRS)) before and after transplantation
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Comparison of the clinical evolution (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) of transplanted patients with that of non-transplanted patients in the BioHD cohort
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Events and adverse reactions recording since the transplantation
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Research and identification of anti-MHC Ab from samples acquired under the MIG-HD and Post-MIGHD protocols as well as in care
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Correlation between graft activity measured by imaging and patient performance
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Correlation between post-mortem observations of the brains of deceased patients and measurements obtained by MRI and PET-SCAN in studies MIG-HD and BioHD
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Correlation between post-mortem brain observations and patient performance before death
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Analysis of brains collected as part of MIG-HD and POST-MIGHD i) to quantify neuropathological lesions ii) to search for markers of inflammatory reactions
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
Research into predictive factors (relationships between fetal haplotypes, patient haplotypes and appearance of alloimmunization phenomena) of the evolution of transplanted patients
Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed
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 8 Jan 2024.
- Individual participant dataSharing planned: No. DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Anne-Catherine BACHOUD-LEVI, MD, PhD contact
Anne-Catherine BACHOUD-LEVI, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up in people with Huntington Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 3 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 8 Jan 2024. 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 France. 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 Anne-Catherine BACHOUD-LEVI, MD, PhD (1 49 81 43 01 ext. +33, anne-catherine.bachoud-levi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of the Unified Huntington's Disease Rating Scale (UHDRS) motor score (time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed). 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?
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 8 Jan 2024.