CClinicalTrials.gg
CompletedNCT03269045Updated Jan 17, 2018

Study of ORL-1B in Patients With Biotinidase Deficiency

A Phase 1/2 interventional study of ORL-1B in Biotinidase Deficiency, sponsored by Orpha Labs. Completed. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Orpha Labs · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study summary

An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.

02

Conditions studied

  • Biotinidase Deficiency
03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of biotinidase deficiency.
  • Less than 18 years old.

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of any other disease that is not a manifestation of biotinidase deficiency.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Treatment with ORL-1B.

    Pediatric patients with biotinidase deficiency.

    Drug: ORL-1B

Interventions

  • DrugORL-1B

    Oral ORL-1B

05

What researchers measure

Primary outcomes

  1. Improvement in seizure frequency

    Statistically significant improvement in seizure frequency after the ORL-1B treatment.

    Time frame: 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03269045
Lead sponsor
Orpha Labs
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Aug 31, 2013
Primary completion
Jan 1, 2018
Completion
Jan 1, 2018
Last update
Jan 17, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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