Huntington's ChoreaPhase 2NCT03575676
Efficacy and Safety of SOM3355 in Huntington's Disease Chorea
A Phase 2 study testing SOM3355 100mg BID and SOM3355 200mg BID in people with Huntington's Chorea, run by SOM Innovation Biotech SA at 4 sites in Spain.
Trial summary
Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington's Chorea
- What is being tested?
- SOM3355 100mg BID and SOM3355 200mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesSpain
- Study dates
- 8 Aug 2018to 22 Aug 2019
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age at time of consent.
- Diagnosis of HD definite by a movement disorders expert and confirmed by a number of HTT gene CAG repeats equal or greater than 36.
- Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control.
- Ability to walk independently or with minimal assistance.
- UHDRS TMC score equal or greater than 8.
- UHDRS TFC equal or greater than 4.
- Subject has provided written informed consent or through his/her legally authorized representative.
Who cannot join
- Onset of HD symptoms prior to age 18 (Juvenile forms of HD).
- Non-ambulatory patients.
- A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome.
- Pregnant or breastfeeding female patients, including those planning to conceive during the period of the trial.
- Patients with psychiatric symptoms, or other impairments, that would interfere with their full compliance with the Investigator instructions and testing, unless there is an identified caregiver to support the patient.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject's medical history and/or clinical laboratory test results at screening and baseline.
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- Known allergy/sensitivity/intolerance to the study drugs or their excipients.
- Any significant laboratory results which, in the Investigator's opinion, would not be compatible with study participation or represent a risk for the subject while in the study.
- Prescribed anti-hypertensive medication, tetrabenazine, deutetrabenazine or valbenazine within 15 days prior starting the investigational treatment.
- Excluded concomitant medications: any anti-hypertensive medication, tetrabenazine, deutetrabenazine or valbenazine, all typical neuroleptics and all MAO inhibitors
- Subject has a history of alcohol or substance abuse in the previous 12 months.
- Patients with diabetic ketoacidosis or metabolic acidosis.
- Patients with cardiogenic shock, congestive heart failure, pulmonary hypertension due to right-sided heart failure, severe sinus bradycardia, atrioventricular block (grades II and III) or sinoatrial block.
- Subject has participated in an investigational drug or device trial within 30 days prior starting the investigational treatment.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Clínic de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
About this study
Official title: Phase IIa, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of SOM3355 in Huntington's Disease (HD) Patients With Chorea Movements.
Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease
- Conditions
- Huntington's Chorea
- Being tested
- SOM3355 100mg BID, SOM3355 200mg BID, Placebo BID
- Keywords
- Huntington, Chorea, SOM3355
- Medical subject headings
- Huntington Disease, Chorea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOM3355 100mg BIDDrug
Oral
SOM3355 200mg BIDDrug
Oral
Placebo BIDDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Administration of SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks, SOM3355 100mg BID for 6 weeks and placebo BID for 6 weeks. Receives: Drug: SOM3355 100mg BID; Drug: SOM3355 200mg BID; Drug: Placebo BID |
| Group B | Experimental | Administration of placebo BID for 6 weeks, SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks and SOM3355 100mg BID for 6 weeks. Receives: Drug: SOM3355 100mg BID; Drug: SOM3355 200mg BID; Drug: Placebo BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
UHDRS (Unified Huntington's Disease Rating Scale) Total Maximal Chorea (TMC) score
UHDRS subscore used to measure the effectiveness of SOM3355 on HD chorea.
Measured: 6 months
Secondary outcomes (8)
Clinical Global Impression of Change (CGIC) scale
PGIC reflects clinician's belief about the efficacy of treatment.
Measured: 6 months
Patient Global Impression of Change (PGIC) scale
PGIC reflects a patient's belief about the efficacy of treatment.
Measured: 6 months
UHDRS Total Functional Capacity (TFC)
A standardized rating scale used to assess capacity to work, handle finances, perform domestic chores and self-care tasks.
Measured: 6 months
UHDRS Functional Assessment
Functional Assessment should be judged according to the investigator's opinion of capacity to perform the activity rather than the actual performance of this activity.
Measured: 6 months
UHDRS Gait score
UHDRS subscore used to assess patient's gait.
Measured: 6 months
UHDRS Total Motor Score (TMS)
Categoric clinical rating scale assessing multiple domains of motor disability in HD.
Measured: 6 months
Columbia Suicide Severity Rating Scale (C-SSRS)
International validated questionnaire used for suicide assessment.
Measured: 6 months
Safety (number of participants with adverse events)
The maximum grade for each type of AE will be recorded for each subject, and frequency tables will be presented and reviewed to determine patterns. The relationship of the AE to the study treatment will be taken into consideration. Hypotension and cardiovascular events will be specifically analyzed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start8 Aug 2018
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
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 Huntington's ChoreaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOM Innovation Biotech SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575676
- Sponsor's protocol ID
- SOMCT02
- Other IDs
- 2018-000203-16, 2018
- Status last verified
- Sep 2019
- First submitted
- 11 Jun 2018
- Last updated
- 16 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gamez J, Calopa M, Munoz E, Ferre A, Huertas O, McAllister K, Reig N, Scart-Gres C, Insa R, Kulisevsky J. A proof-of-concept study with SOM3355 (bevantolol hydrochloride) for reducing chorea in Huntington's disease. Br J Clin Pharmacol. 2023 May;89(5):1656-1664. doi: 10.1111/bcp.15635. Epub 2022 Dec 28.
PubMed 36494329
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of SOM3355 in Huntington's Disease (HD) Patients With Chorea Movements.
- ClinicalTrials.gov ID
- NCT03575676
- Acronym / sponsor ID
- SOMCT02
- Conditions
- Huntington's Chorea
- Keywords
- Huntington, Chorea, SOM3355
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SOM Innovation Biotech SAIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 2 Jul 2018 (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.
Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: SOM3355 100mg BID, Drug: SOM3355 200mg BID, Drug: Placebo BIDAdministration of SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks, SOM3355 100mg BID for 6 weeks and placebo BID for 6 weeks. |
| Group B | Experimental | Drug: SOM3355 100mg BID, Drug: SOM3355 200mg BID, Drug: Placebo BIDAdministration of placebo BID for 6 weeks, SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks and SOM3355 100mg BID for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is at least 18 years of age at time of consent.
- Diagnosis of HD definite by a movement disorders expert and confirmed by a number of HTT gene CAG repeats equal or greater than 36.
- Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control.
- Ability to walk independently or with minimal assistance.
- UHDRS TMC score equal or greater than 8.
Key exclusion criteria (14 listed)
- Onset of HD symptoms prior to age 18 (Juvenile forms of HD).
- Non-ambulatory patients.
- A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome.
- Pregnant or breastfeeding female patients, including those planning to conceive during the period of the trial.
- Patients with psychiatric symptoms, or other impairments, that would interfere with their full compliance with the Investigator instructions and testing, unless there is an identified caregiver to support the patient.
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 |
|---|---|---|
| SOM3355 100mg BIDOral | Drug | Group A, Group B |
| SOM3355 200mg BIDOral | Drug | Group A, Group B |
| Placebo BIDOral | Drug | Group A, Group B |
Primary outcome
UHDRS (Unified Huntington's Disease Rating Scale) Total Maximal Chorea (TMC) score
Time frame: 6 months
UHDRS subscore used to measure the effectiveness of SOM3355 on HD chorea.
8 secondary outcomes
Clinical Global Impression of Change (CGIC) scale
Time frame: 6 months
Patient Global Impression of Change (PGIC) scale
Time frame: 6 months
UHDRS Total Functional Capacity (TFC)
Time frame: 6 months
UHDRS Functional Assessment
Time frame: 6 months
UHDRS Gait score
Time frame: 6 months
UHDRS Total Motor Score (TMS)
Time frame: 6 months
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 6 months
Safety (number of participants with adverse events)
Time frame: 6 months
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 16 Sep 2019.
- Derived from this study: PubMed 36494329Gamez J, Calopa M, Munoz E, Ferre A, Huertas O, McAllister K, Reig N, Scart-Gres C, Insa R, Kulisevsky J. A proof-of-concept study with SOM3355 (bevantolol hydrochloride) for reducing chorea in Huntington's disease. Br J Clin Pharmacol. 2023 May;89(5):1656-1664. doi: 10.1111/bcp.15635. Epub 2022 Dec 28.
- SOM Biotech websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOM3355 100mg BID and SOM3355 200mg BID in people with Huntington's Chorea, run by SOM Innovation Biotech SA at 4 sites in Spain.
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 7 inclusion and 14 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 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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 phase mean?
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?
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?
UHDRS (Unified Huntington's Disease Rating Scale) Total Maximal Chorea (TMC) score (time frame: 6 months). 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 NCT03575676, 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 16 Sep 2019.