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Trial record 1 of 1 for:    ipsen huntington
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Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02231580
First Posted: September 4, 2014
Last Update Posted: December 1, 2016
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.
Information provided by (Responsible Party):
Ipsen
  Purpose
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BN82451B versus placebo after oral administration twice daily (bid) for 28 days in patients with Huntington's Disease (HD).

Condition Intervention Phase
Huntington's Disease Drug: BN82451B Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Escalation, Proof of Concept, Phase IIa Study to Investigate the Safety and Tolerability, the Pharmacokinetic and the Pharmacodynamic of BN82451B, Administered Twice Daily Over 4 Weeks, in Male Patients With Huntington's Disease

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 28 days ]

Secondary Outcome Measures:
  • Area Under the Plasma Concentration-Time Curve (AUC 0-12h) [ Time Frame: Days 1, 14 and 28 post-dose ]
  • Change from Baseline in Q-Motor tests at Day 28 [ Time Frame: Baseline, Day 28 ]
    Q-Motor tests is the quantitative measure of motor function.


Enrollment: 25
Study Start Date: September 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BN82451B
BN82451B capsule: Up to 3 dose levels (40, 60 or 80 mg) twice daily administered orally.
Drug: BN82451B
BN82451B capsule
Placebo Comparator: Placebo
Placebo capsule: Up to 3 dose levels (40, 60 or 80 mg) twice daily administered orally.
Drug: Placebo
Placebo capsule

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects 20 to 70 years old (inclusive).
  • Provision of written informed consent prior to any study related procedures. In this study consent may be provided by the legal guardian or carer.
  • Confirmed symptomatic Huntington's Disease diagnosed based on clinical features (i.e. Diagnostic Confidence Level equal to 4) and presence of at least 36 cytosine adenine guanine (CAG) repeats in the Huntington gene as documented by a copy of a previous genetic test report.
  • Unified Huntington's Disease Rated Scale-Total Motor Score (UDHRS-TMS) greater than or equal to 15.
  • Ambulatory.
  • UDHRS-Total Functional Capacity (TFC) greater than or equal to 3 (i.e. Shoulson & Fahn Scale stages 1-3 inclusive.
  • Subjects on antipsychotic, antidepressant, anxiolytic and hypnotic therapy must have been on stable treatment 4 weeks prior to study drug start and during the study period.
  • Able to swallow study medication.
  • Able to perform Q-Motor tests.
  • If his partner is at risk of pregnancy, the subject agrees to use a condom or be abstinent for 14 days after the last intake of study drug.

Exclusion Criteria:

  • Juvenile forms of Huntington's Disease.
  • Any form of chorea other than Huntington's Disease.
  • History of seizure, epilepsy or other convulsive disorder, with the exception of febrile seizures in childhood.
  • History of conditions susceptible to induce seizures such as severe traumatic brain injury, brain tumours, stroke.
  • History of neurosurgical procedure.
  • Current evidence or history (within 1 year of Baseline) of psychosis, hallucinations or delusions, including major depression with psychotic features, as defined in the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR). Patients currently experiencing mild depression, or moderate depression which is adequately and appropriately treated in the judgement of the investigator, can participate if depression is not expected to interfere with study participation.
  • History of drug and/or alcohol abuse as per the DSM IV-TR criteria within 12 months prior to Baseline.
  • At imminent risk of self harm based on investigator's clinical judgment, with a "yes" answer on item 4 or 5 on the Columbia-Suicide Severity Rating Scale (CSSRS) questionnaire.
  • Mini Mental State Exam (MMSE) total score less than or equal to 23.
  • Used any investigational drugs within 30 days prior to Screening or 5 half lives, whichever is the longest.
  • Known allergy/sensitivity to the study drugs or their excipients.
  • A severe or ongoing unstable medical condition (e.g. cardiac, hepatic, renal, metabolic or endocrine).
  • Any clinically significant condition which, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
  • Any significant laboratory results which, in the investigator's opinion, would not be compatible with study participation or represent a risk for subjects while in the study.
  • History of malignant disease within the 5 years prior to Screening (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised, in situ prostate cancer with a normal prostate specific antigen).
  • An estimated Creatinine Clearance (CrCl) of less than 60 mL/minute (using the Cockcroft-Gault formula).
  • Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) values greater than or equal to 2 times the Upper Limit of Normal range (ULN) or both GGT and ALT values greater than three times the ULN.
  • Known history of hepatitis B or C or Human Immunodeficiency Virus (HIV) or positive serology at Screening.
  • Corrected QT interval using Bazett's correction (QTcB) greater than 450 ms or other clinically significant ECG findings.
  • Receiving tetrabenazine within 4 weeks prior to Baseline.
  • Taking the following prohibited medications/substances: Strong Cytochrome (CYP) 3A4 inhibitors and Strong CYP3A4 inducers (Wash out prior to Baseline 30 days or 5 half lives,whichever is the longest), CYP2B6 substrates, CYP1A2 substrates, CYP3A4 substrates, CYP2C19 substrates (assessed on a case by case basis)
  Contacts and Locations
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): NCT02231580


Locations
Germany
Monchengladbach, Germany
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Philippe Picaut Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02231580     History of Changes
Other Study ID Numbers: 8-55-52966-005
2013-002899-41 ( EudraCT Number )
First Submitted: September 2, 2014
First Posted: September 4, 2014
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Ipsen:
Neurodegenerative genetic disorder

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