: The Role of Keppra in the Treatment of Tremor in Multiple Sclerosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003903-35-GB

Enrollment

Registered

2005-12-19

Start date

2006-01-19

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

Multiple Sclerosis

Interventions

Trade Name: Keppra 250mg Pharmaceutical Form: INN or Proposed INN: Levetiracetam Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. McDonald criteria for diagnosis of MS (McDonald, 2001)16 2. Clinical evidence of Cerebellar Tremor. 3. Aged 18-60 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. There is evidence of a further significant MS relapse during the trial 2. Evidence of resting tremor, or Holmes (rubral) tremor 3. Patients already on specific anti-tremor medication 4. Pregnant or breast feeding mothers

Design outcomes

Primary

Measure	Time frame
Primary end point(s): An objective measure of tremor will be performed using an accelerometer which will be attached to the limb under investigation, providing a sensitive measure of oscillatory movement. EMG will be recorded from muscles using adhesive surface electrodes, allowing direct measurement of oscillatory patterns of muscle activation. The amplitude of power spectral peaks in EMG and acceleration will provide an objective measure of the extent of tremor. The assessment will be carried out by a clinician, who will be blinded to the treatment group. At each assessment during the trial the patient will be required to perform 4 physiologically relevant manual tasks which will distinguish action tremor from resting tremor: 1. Rest (no voluntary EMG activity) 2. Holding task (finger in a fixed posture pointing at a stationary target) 3. Slow finger movement task (arm fixed and finger tracking a moving sinusoidal target) 4. Precision grip task 5. Targeted whole-arm reaching movements ;Main Objective: To determine whether Keppra can be used to reduce tremor in patients suffering from Multiple Sclerosis.;Secondary Objective:	—

Measure

Time frame

Primary end point(s): An objective measure of tremor will be performed using an accelerometer which will be attached to the limb under investigation, providing a sensitive measure of oscillatory movement. EMG will be recorded from muscles using adhesive surface electrodes, allowing direct measurement of oscillatory patterns of muscle activation. The amplitude of power spectral peaks in EMG and acceleration will provide an objective measure of the extent of tremor. The assessment will be carried out by a clinician, who will be blinded to the treatment group. At each assessment during the trial the patient will be required to perform 4 physiologically relevant manual tasks which will distinguish action tremor from resting tremor: 1. Rest (no voluntary EMG activity) 2. Holding task (finger in a fixed posture pointing at a stationary target) 3. Slow finger movement task (arm fixed and finger tracking a moving sinusoidal target) 4. Precision grip task 5. Targeted whole-arm reaching movements ;Main Objective: To determine whether Keppra can be used to reduce tremor in patients suffering from Multiple Sclerosis.;Secondary Objective:

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Countries

United Kingdom

Outcome results

None listed

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