NCT01806896

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Huntington's Disease

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-03-07
• Last updated: 2017-12-14
• Results posted: 2017-12-14

Locations

1 site across 1 country: France