Double-bllind, randomised, placebo-controlled trial of levetiracetam in painful polyneuropathy - levetiraetam in painful polyneuropathy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003046-33-DK

Enrollment

Registered

2005-07-18

Start date

2005-09-02

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Painful polyneuropathy (idiopathic, diabetic, alcoholic, drug-induced and other etiologies)

Interventions

Trade Name: keppra Product Name: levetiracetam Product Code: ucb L059 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. age 20-80 years 2. polyneuropathy pain symptoms for at least 6 months 3. polyneuropathy diagnosis confirmed by nerve conduction studies 4. average baseline pain score of at least 4 on a 0 to 10 numeric rating scale 5. informed consent 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. additional cause of pain 2. allergic reactions towards levetiracetam 3. pregnancy or breast feeding period 4. severe illness 5. lack of ability to follow study protocol 6. treatment with antidepressants, anticonvulsants or opioids

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if Levetiracetam will relieve painful polyneuropathy;Secondary Objective: In patients with painful polyneuropathy to determine the effects of levetiracetam on 1. specific pain symptoms 2. on quality of life 3. pain related sleep disturbance;Primary end point(s): Patient verbal score of pain relief (complete, good, moderate, slight, no, worse) at the end of each treatment period	—

Measure

Time frame

Main Objective: To determine if Levetiracetam will relieve painful polyneuropathy;Secondary Objective: In patients with painful polyneuropathy to determine the effects of levetiracetam on 1. specific pain symptoms 2. on quality of life 3. pain related sleep disturbance;Primary end point(s): Patient verbal score of pain relief (complete, good, moderate, slight, no, worse) at the end of each treatment period

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Countries

Denmark

Outcome results

None listed

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