Trial of lactose supplementation in CDG
Phase 2
- Conditions
- Congenital disorder of glycosylation
- Registration Number
- JPRN-jRCTs061200059
- Lead Sponsor
- Maegaki Yoshihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Patients with
1) CDG having the mutation in one of the genes of SLC35A2, PGM1, SLC39A8, or TMEM165.
2) At least one epileptic seizure 28 days prior to the drug administration.
Exclusion Criteria
Patients with
1) Dairy allergies.
2) Lactose intolerance.
3) Diabetes mellitus.
4) Severe liver, renal, or cardiac dysfunction.
5) Pregnancy or nursing.
6) Participating in other clinical trials or stidies within three months before enrollment.
7) Judgement to be ineligible for trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences of frequencies of epileptic seizures between baseline and 52 weeks later.
- Secondary Outcome Measures
Name Time Method Variabilities of<br>1) Epileptic seizures<br>2) Scores of Nijmegen Pediatric CDG Rating Scale<br>3) Interictal epileptiform discarges in EEG<br>4) Serum galactosylglycan