Improving diagnosis and treatment of attention deficits in head injured patients - Pharmacological treatment for head injured patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004921-89-GB

Enrollment

Registered

2005-02-15

Start date

2005-05-25

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Attention difficulties after closed head injury

Interventions

Trade Name: Equasym Product Name: Equasym Pharmaceutical Form: Tablet INN or Proposed INN: Methylphenidate Hydrochloride Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 6+ months post closed head injury, persistent attention difficulties, good recovery (Glasgow Outcome Scale equal to 5) Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of neurological/psychiatric disorder, drug abuse, cardiac arrhytmia, high blood pressure

Design outcomes

Primary

Measure	Time frame
Main Objective: To provide an objective method to identify which head injured patients with attention deficits benefit from which drug in order to select the effective treatment;Secondary Objective: To improve the diagnosis and treatment of attention deficit after closed head injury, and throught it, the quality of life of these patients and their families. ;Primary end point(s): Normalisation of event-related brain potentials (ERPs), improved behavioural measures	—

Measure

Time frame

Main Objective: To provide an objective method to identify which head injured patients with attention deficits benefit from which drug in order to select the effective treatment;Secondary Objective: To improve the diagnosis and treatment of attention deficit after closed head injury, and throught it, the quality of life of these patients and their families. ;Primary end point(s): Normalisation of event-related brain potentials (ERPs), improved behavioural measures

—

Countries

United Kingdom

Outcome results

None listed

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