The effect of methylphenidate (Ritalin®) on the severity of stuttering.

The effect of methylphenidate (Ritalin®) on the severity of stuttering. - The effect of methylphenidate (Ritalin®) on the severity of stuttering.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005146-55-BE

Enrollment

Registered

2015-12-10

Start date

2016-01-27

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

Stuttering

Interventions

Trade Name: Rilatine Product Name: Rilatine Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Men Developmental stuttering 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Psychological disorders: depression, psychosis, bipolar disorder. Psychogenic of neurogenic stuttering Adhd. Narcolepsy. Use of methylphenidate (now or in the past). AHT (blood pressure above 140/90). Use of benzodiazepines, neuroleptics such as haloperidol, amphetamines, anti- emetics such as metoclopramide and domperidone, L-dopa, MAO inhibitors. Stroke or TIA. Hyperthyroidism. Cocaine or other drug use (now or in the past). Drug addiction (now or in the past). Glaucoma. Alcoholism. Known liver disease. Epilepsy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does methylphenidate effect on the severity of developmental stuttering in adults?;Secondary Objective: not applicable;Primary end point(s): Measuring the number of: repeats, sounds, syllables, words, middle positions, blockades, audible, silences, stress;Timepoint(s) of evaluation of this end point: Before start administration, and after 2 weeks administration of 20 mg methylphenidate per day. Before start placebo and after 2 weeks of placebo.	—

Measure

Time frame

Main Objective: Does methylphenidate effect on the severity of developmental stuttering in adults?;Secondary Objective: not applicable;Primary end point(s): Measuring the number of: repeats, sounds, syllables, words, middle positions, blockades, audible, silences, stress;Timepoint(s) of evaluation of this end point: Before start administration, and after 2 weeks administration of 20 mg methylphenidate per day. Before start placebo and after 2 weeks of placebo.

—

Secondary

Measure	Time frame
Secondary end point(s): Subjective effect of methylphenidate on stuttering.;Timepoint(s) of evaluation of this end point: Before start administration, and after 2 weeks administration of 20 mg methylphenidate per day. Before start placebo and after 2 weeks of placebo.	—

Countries

Belgium

Contacts

Public ContactVakgroep huisartsgeneeskunde

Vrije Universiteit Brussel

huisarts@vub.ac.be003224774311

Outcome results

None listed

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