Study identification

EU PAS number

EUPAS41367

Study ID

41368

Official title and acronym

Retrospective registry study evaluating the safety of melatonin use in children and adolescents with attention deficit hyperactivity disorder (ADHD) in Sweden (Safety of melatonin in children with ADHD)

DARWIN EU® study

No

Study countries

Sweden

Study description

AGB-Pharma was provided a post-authorisation commitment by the Medical Products Agency (MPA) to conduct a PASS-study (Category 3) in connection to the approval of Melatonin AGB via a National procedure for the indication: Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient. The background for this commitment was the theoretical concern on the effect of melatonin on sexual maturation in children and adolescents with ADHD. The retrospective aspect of this study was proposed by the MPA, and a feasibility assessment was undertaken by AGB-Pharma, supported by LINK Medical Research. After the feasibility assessment it was found that it is possible to design a retrospective registry study on safety, concerning height development, in children with ADHD. However, it is not feasible to evaluate the safety of long-term treatment with melatonin on sexual maturation, as no data on pubertal timing exists in any central registry in Sweden. The objective of this PASS study is to study the height development in children and adolescents with ADHD, which are prescribed melatonin. The primary objective is to determine whether long-term treatment of melatonin (30≥ days) influences height development in children and adolescence with ADHD. As a secondary reference PC PAL national standard growth chart will be used, which follows growth in relation to age. The exploratory objective of this study is to describe melatonin use in the population of interest, including medicine adherence, duration of treatment and dosing. Also, the study aims to compare the growth of children and adolescents with ADHD and prescribed melatonin with national Swedish growth charts

Study status

Finalised

Contact details

Peik Gustafsson

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AGB-Pharma AB
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)