Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01806896
First received: March 6, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.


Condition Intervention Phase
Huntington's Disease
Drug: PF-02545920
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind Randomized, Sequential Treatment Group, Placebo-controlled Study To Evaluate The Safety, Tolerability And Brain Cortico-striatal Function Of 2 Doses Of Pf-02545920 In Subjects With Early Huntington's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from Baseline to Day 28 of Unified Huntington Disease Rating Scale -Total Motor Score (TMS) [ Time Frame: Screening, Day 1, Day 28 ] [ Designated as safety issue: Yes ]
    The UHDRS is a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. the Total Motor Score (TMS) is one of the six sub components of UHDRS.


Secondary Outcome Measures:
  • Change from Baseline to Day28 in fMRI parameter estimates and percent signal change during Monetary Incentive Delay [ Time Frame: Baseline, Day28 ] [ Designated as safety issue: No ]
    The monetary incentive delay (MID) task is established as a reliable method to elicit ventral striatal activity in relation to reward/punishment anticipation and tracked with dysfunctionalities across a range of conditions in which incentive motivation is thought to be abnormal (schizophrenia, depression, substance abuse, and pathological gambling). Pharmacological intervention has demonstrated reversal of observed deficit.

  • Change from Baseline to Day28 in Grip Strength Incentive Motivation task score [ Time Frame: Baseline predose, Baseline postdose, Day28 ] [ Designated as safety issue: No ]
    This incentive force task was developed to independently dissociate the degree to which a subject responds to reward motivation versus emotional motivation, as well as a subject's perception of difficulty level in performing a given task.


Estimated Enrollment: 56
Study Start Date: September 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20 mg Arm Cohort A Drug: PF-02545920
  • Dose will be titrated up every 2 days by 5mg increments: 5mg Days 1-2, 10mg days 3-4, 15mg days 5-6, and reach 20 mg from Days 7 to Day28.
  • Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
  • Treatment for 28 days.
Placebo Comparator: Placebo Arm Cohort A Drug: Placebo

- Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.

Dosing for 28 days.

Experimental: 5 mg Arm Cohort B Drug: PF-02545920
  • 5mg dose
  • Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
  • Dosing for 28 days.
Placebo Comparator: Placebo Arm Cohort B Drug: Placebo
  • Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
  • Dosing for 28 days.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a diagnosis of Huntington's Disease
  • a CAG repeat expansion equal or great than 39
  • a Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score equal or greater than 5 and less than 60
  • a UHDRS Total Functional Capacity equal or greater than 9

Exclusion Criteria:

  • Subjects with evidence or history of severe acute or chronic medical condition or laboratory abnormality, or significant neurological disorder other than HD.
  • Treatment with any antipsychotic medication within 5 weeks of enrollment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806896

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
France
Centre d'Investigation Clinique (CIC)/ Institut du Cerveau et de la Möelle Epinière (ICM) Recruiting
Paris Cedex 13, France, 75651
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01806896     History of Changes
Other Study ID Numbers: A8241016, 2012-004432-31
Study First Received: March 6, 2013
Last Updated: October 7, 2014
Health Authority: France: Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM)

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

ClinicalTrials.gov processed this record on October 23, 2014