Pregabalin in patients with central neuropathic pain: a randomised, double-blind, placebo-controlled trial of a flexible-dose regimen

ISRCTN	ISRCTN67414160
DOI	https://doi.org/10.1186/ISRCTN67414160
Secondary identifying numbers	NTR852; 1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M R Kruis
Scientific

Academic Medical Center (AMC)
Pijncentrum
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Study design	Randomised, triple blind, placebo controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	We tested, in a randomised, double-blind, placebo-controlled trial, the effects of pregabalin on pain relief, tolerability, health status, and quality of life in patients with central neuropathic pain.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Central neuropathic pain
Intervention	Pregabalin versus placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Pregabalin
Primary outcome measure	The primary efficacy parameter is a pain intensity score recorded by patients (at baseline, and four weeks following treatment), using a Visual Analog Scale (VAS).
Secondary outcome measures	Health status and Quality of Life (QOL) questionnaires (secondary outcomes) were completed before start of treatment and four weeks following start of treatment. Health status and QOL measurements included the Pain Disability Index (PDI), the EuroQoL questionnaire (EQ-5D), and the Medical Outcomes Short-Form Health Survey questionnaire 36 (SF 36).
Overall study start date	01/01/2006
Completion date	30/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	40
Key inclusion criteria	1. Age 18 years or older 2. Written informed consent 3. Patients suffering from severe neuropathic pain caused by lesion or dysfunction in the central nervous system. Neuropathic pain was described by at least one of the following: a. burning pain b. paroxysmal episodes of shooting pain c. pain on light touch Additionally, patients had to score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS)
Key exclusion criteria	1. Pregnant 2. Had a history of intolerance, hypersensitivity, or known allergy to pregabalin 3. Had a known history of significant hepatic, renal, or psychiatric disorder 4. Had a history of galactose-intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome 5. Subjects with a calculated creatinine clearance rate below 60 mL/m (estimated from serum creatinine using Cockroft-Gault equation) were specifically excluded 6. No new analgesic therapies were to be initiated at any time during the trial 7. Patients who had been exposed previously to gabapentin, regardless of dose and treatment duration, were permitted to enter the study. However, treatment with gabapentin was to be discontinued at least three days before receiving study medication
Date of first enrolment	01/01/2006
Date of final enrolment	30/12/2006

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Academic Medical Center (AMC) (Netherlands)
Hospital/treatment centre

Department of Anesthesiology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Hospital/treatment centre

Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2008		Yes	No