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Efficacy and Safety of SOM3355 in Huntington's Disease Chorea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575676
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
SOM Biotech SL

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE July 2, 2018
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE August 8, 2018
Actual Primary Completion Date August 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • Clinical Global Impression of Change (CGIC) scale [ Time Frame: 6 months ]
    PGIC reflects clinician's belief about the efficacy of treatment.
  • Patient Global Impression of Change (PGIC) scale [ Time Frame: 6 months ]
    PGIC reflects a patient's belief about the efficacy of treatment.
  • UHDRS Total Functional Capacity (TFC) [ Time Frame: 6 months ]
    A standardized rating scale used to assess capacity to work, handle finances, perform domestic chores and self-care tasks.
  • UHDRS Functional Assessment [ Time Frame: 6 months ]
    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.
  • UHDRS Gait score [ Time Frame: 6 months ]
    UHDRS subscore used to assess patient's gait.
  • UHDRS Total Motor Score (TMS) [ Time Frame: 6 months ]
    Categoric clinical rating scale assessing multiple domains of motor disability in HD.
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ]
    International validated questionnaire used for suicide assessment.
  • Safety (number of participants with adverse events) [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of SOM3355 in Huntington's Disease Chorea
Official Title  ICMJE Phase IIa, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of SOM3355 in Huntington's Disease (HD) Patients With Chorea Movements.
Brief Summary Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Chorea
Intervention  ICMJE
  • Drug: SOM3355 100mg BID
    Oral
  • Drug: SOM3355 200mg BID
    Oral
  • Drug: Placebo BID
    Oral
Study Arms  ICMJE
  • Experimental: Group A
    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.
    Interventions:
    • Drug: SOM3355 100mg BID
    • Drug: SOM3355 200mg BID
    • Drug: Placebo BID
  • Experimental: Group B
    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.
    Interventions:
    • Drug: SOM3355 100mg BID
    • Drug: SOM3355 200mg BID
    • Drug: Placebo BID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
30
Actual Study Completion Date  ICMJE August 22, 2019
Actual Primary Completion Date August 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03575676
Other Study ID Numbers  ICMJE SOMCT02
2018-000203-16 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SOM Biotech SL
Study Sponsor  ICMJE SOM Biotech SL
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SOM Biotech SL
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP