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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 : Active, not recruiting
First Posted : July 2, 2018
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
SOM Biotech SL

Brief Summary:
Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease

Condition or disease Intervention/treatment Phase
Huntington's Chorea Drug: SOM3355 100mg BID Drug: SOM3355 200mg BID Drug: Placebo BID Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
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.
Drug: SOM3355 100mg BID
Oral

Drug: SOM3355 200mg BID
Oral

Drug: Placebo BID
Oral

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.
Drug: SOM3355 100mg BID
Oral

Drug: SOM3355 200mg BID
Oral

Drug: Placebo BID
Oral




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical Global Impression of Change (CGIC) scale [ Time Frame: 6 months ]
    PGIC reflects clinician's belief about the efficacy of treatment.

  2. Patient Global Impression of Change (PGIC) scale [ Time Frame: 6 months ]
    PGIC reflects a patient's belief about the efficacy of treatment.

  3. 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.

  4. 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.

  5. UHDRS Gait score [ Time Frame: 6 months ]
    UHDRS subscore used to assess patient's gait.

  6. UHDRS Total Motor Score (TMS) [ Time Frame: 6 months ]
    Categoric clinical rating scale assessing multiple domains of motor disability in HD.

  7. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ]
    International validated questionnaire used for suicide assessment.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575676


Locations
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Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Sponsors and Collaborators
SOM Biotech SL

Additional Information:
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Responsible Party: SOM Biotech SL
ClinicalTrials.gov Identifier: NCT03575676     History of Changes
Other Study ID Numbers: SOMCT02
2018-000203-16 ( EudraCT Number )
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SOM Biotech SL:
Huntington
Chorea
SOM3355

Additional relevant MeSH terms:
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Huntington Disease
Chorea
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms