Effect of propentofylline in children with autism

Effect of propentofylline add on therapy to risperidon in children with autism: a randomized double-blind placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090117001556N113

Enrollment

Registered

2018-11-15

Start date

2018-11-22

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

Autistic disorder. Autistic disorder

Interventions

Intervention 1: Intervention group: Intervention group: intervention group: Cap. of propentofylline ?(300 mg BID) plus Risperidone ( 1 to 3.5 mg per day) for 12 weeks. Intervention 2: Control group:

Eligibility

Sex/Gender

All

Age

4 Years to 11 Years

Inclusion criteria

Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder Children between the ages of 4 and 11 years old score 12 or more inirritability subscale of ABC-C

Exclusion criteria

Exclusion criteria: Presence of any active medical problem Receiving any psychotropic medications except for risperidone during 2 weeks prior to the trial Severe hepatic disease History of allergy to risperidone and intolerance of it History of seizure requiring change of antiepileptic dose during the last month Seizure during the last 6 months

Design outcomes

Primary

Measure	Time frame
Severity of autism. Timepoint: Baseline and weeks 4, 8 and 12. Method of measurement: By Aberrant Behavior Checklist-Community( ABC-C) and Childhood Autism Rating scale( CARS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026