A Phase 2 interventional study of SOM3355 100mg BID and SOM3355 200mg BID in Huntington's Chorea, sponsored by SOM Innovation Biotech SA. Completed at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-16.
Sponsored by SOM Innovation Biotech SA · Phase 2, Interventional, and Treatment
Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease
293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 207 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →SOM Innovation Biotech SA is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: SOM3355 100mg BID · Drug: SOM3355 200mg BID · Drug: Placebo BID
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.
Drug: SOM3355 100mg BID · Drug: SOM3355 200mg BID · Drug: Placebo BID
Oral
Oral
Oral
UHDRS (Unified Huntington's Disease Rating Scale) Total Maximal Chorea (TMC) score
UHDRS subscore used to measure the effectiveness of SOM3355 on HD chorea.
Time frame: 6 months
Clinical Global Impression of Change (CGIC) scale
PGIC reflects clinician's belief about the efficacy of treatment.
Time frame: 6 months
Patient Global Impression of Change (PGIC) scale
PGIC reflects a patient's belief about the efficacy of treatment.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
UHDRS Gait score
UHDRS subscore used to assess patient's gait.
Time frame: 6 months
UHDRS Total Motor Score (TMS)
Categoric clinical rating scale assessing multiple domains of motor disability in HD.
Time frame: 6 months
Columbia Suicide Severity Rating Scale (C-SSRS)
International validated questionnaire used for suicide assessment.
Time frame: 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.
Time frame: 6 months
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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SOM Innovation Biotech SA