Status:
COMPLETED
A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels
Lead Sponsor:
BioMarin Pharmaceutical
Conditions:
Phenylketonurias
Eligibility:
All Genders
8+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to evaluate the safety and tolerability of long-term Phenoptin treatment in subjects with PKU.
Eligibility Criteria
Inclusion
- 8 years of age and older
- Prior successful participation in Study PKU-003
- Willing and able to provide written informed consent or assent and written informed consent (if required) by a parent or legal guardian
- For females of child-bearing potential only: Negative urine pregnancy test within 24 hours prior to enrollment. Women using acceptable birth control measures must agree to continue to use those measures while participating in the study
- Willing and able to comply with study procedures
- Willing to continue current diet unchanged while participating in the study
Exclusion
- Perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable
- Withdrew from, or otherwise did not successfully complete, study PKU-003, except for subjects who were removed from the study because their blood Phe exceeded the alert level
- Expected to require any investigational agent or vaccine prior to completion of all scheduled study assessments
- Pregnant or breastfeeding, or planning pregnancy
- Concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes)
- Requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate)
- Concurrent use of levodopa
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00225615
Start Date
November 1 2005
End Date
June 1 2006
Last Update
August 20 2009
Active Locations (14)
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1
Los Angeles, California, United States
2
Oakland, California, United States
3
Sacramento, California, United States
4
San Jose, California, United States