Zileuton therapy for Sjogren-Larsson syndrome

Randomised crossover trial to evaluate the effects of Zileuton in patients with Sjogren-Larsson syndrome assessing potential benefit in terms of symptoms (itch), biochemical and neuropsychological indices

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000320550

Enrollment

Registered

2006-07-26

Start date

2006-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is find out whether zileuton helps to improve the symptoms of children with SLS in terms of skin symptoms (itch), neurology and motor function. patients, parents, investigators and asessors blinded - only central pharmacy will be aware of whether the patient is on placebo or treatment at the time (open label period excepted).

Interventions

Zileuton treatment, orally, dosage by weight: 12.5-18.75 kg: 300 mg twice a day 18.75-25 kg: 300 mg three times a day 25-37.5 kg: 300 mg four times a day 37.5-50 kg: 600 mg hree times a day >50 kg: 600 mg qds Patients provide their own internal control as crossover trial with treatment/placebo periods of 3 months separated by a one month wash out period.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 16 Years

Healthy volunteers

Inclusion criteria

Paediatric patients with a clinical diagnosis and biochemically confirmed Sjogren-Larsson syndrome.

Exclusion criteria

Adult patients.

Outcome results