Huntington DiseasePRO-MH2NCT01696708
Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease
A study testing 31-Phosphorus RMN Spectroscopy in people with Huntington Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- 31-Phosphorus RMN Spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2012to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- UHDRS < 50
- Age > 18 years
- Ability to undergo MR scanning
- Covered by french social security
Who cannot join
- Evidence of psychiatric disorder
- Attendant neurological disorder
- Contraindications to MRI (claustrophobia, metallic or material implants)
- Severe head injury
- Unable to understand the protocol
- Pregnancy
Show all 9Show fewer
- Failure to give informed consent
- Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent)
- Unwillingness to be informed in case of abnormal MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.
- Conditions
- Huntington Disease
- Being tested
- 31-Phosphorus RMN Spectroscopy
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
31-Phosphorus RMN SpectroscopyOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | 31-Phosphorus RMN Spectroscopy Receives: Other: 31-Phosphorus RMN Spectroscopy |
| Volunteers | Other | 31-Phosphorus RMN Spectroscopy Receives: Other: 31-Phosphorus RMN Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr
31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate
Measured: 2 years
Secondary outcomes (2)
Correlation between primary outcome measure and clinical parameters
Correlating a brain energy deficit with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).
Measured: 2 years
Study of longitudinal changes in Pi/PCr ratio over time.
Patients will be retested after one month.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study start6 Dec 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fanny Mochel, MD, PhD, Principal investigator, INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696708
- Sponsor's protocol ID
- C12-49
- Other IDs
- 2012-A01063-40
- Acronym
- PRO-MH2
- Status last verified
- Sep 2012
- First submitted
- 20 Sep 2012
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adanyeguh IM, Monin ML, Rinaldi D, Freeman L, Durr A, Lehericy S, Henry PG, Mochel F. Expanded neurochemical profile in the early stage of Huntington disease using proton magnetic resonance spectroscopy. NMR Biomed. 2018 Mar;31(3):10.1002/nbm.3880. doi: 10.1002/nbm.3880. Epub 2018 Jan 9.
PubMed 29315899Adanyeguh IM, Rinaldi D, Henry PG, Caillet S, Valabregue R, Durr A, Mochel F. Triheptanoin improves brain energy metabolism in patients with Huntington disease. Neurology. 2015 Feb 3;84(5):490-5. doi: 10.1212/WNL.0000000000001214. Epub 2015 Jan 7.
PubMed 25568297
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease
- ClinicalTrials.gov ID
- NCT01696708
- Acronym / sponsor ID
- PRO-MH2 / C12-49
- Conditions
- Huntington Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Dec 2012 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Oct 2012 (estimated)
- 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.
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: 31-Phosphorus RMN Spectroscopy31-Phosphorus RMN Spectroscopy |
| Volunteers | Other | Other: 31-Phosphorus RMN Spectroscopy31-Phosphorus RMN Spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- UHDRS < 50
- Age > 18 years
- Ability to undergo MR scanning
- Covered by french social security
Key exclusion criteria (9 listed)
- Evidence of psychiatric disorder
- Attendant neurological disorder
- Contraindications to MRI (claustrophobia, metallic or material implants)
- Severe head injury
- Unable to understand the protocol
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 |
|---|---|---|
| 31-Phosphorus RMN Spectroscopy | Other | Patients, Volunteers |
Primary outcome
Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr
Time frame: 2 years
31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate
2 secondary outcomes
Correlation between primary outcome measure and clinical parameters
Time frame: 2 years
Study of longitudinal changes in Pi/PCr ratio over time.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 29315899Adanyeguh IM, Monin ML, Rinaldi D, Freeman L, Durr A, Lehericy S, Henry PG, Mochel F. Expanded neurochemical profile in the early stage of Huntington disease using proton magnetic resonance spectroscopy. NMR Biomed. 2018 Mar;31(3):10.1002/nbm.3880. doi: 10.1002/nbm.3880. Epub 2018 Jan 9.
- Results publication: PubMed 25568297Adanyeguh IM, Rinaldi D, Henry PG, Caillet S, Valabregue R, Durr A, Mochel F. Triheptanoin improves brain energy metabolism in patients with Huntington disease. Neurology. 2015 Feb 3;84(5):490-5. doi: 10.1212/WNL.0000000000001214. Epub 2015 Jan 7.
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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. This study is not recruiting at the moment.
Fanny Mochel, MD, PhD principal investigator
INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 31-Phosphorus RMN Spectroscopy in people with Huntington Disease, run by Institut National de la Santé Et de la Recherche Médicale, France 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 10 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr (time frame: 2 years). 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 NCT01696708, which also lists 2 linked publications.
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 10 Dec 2025.