pregabalin and Muscle-Spasticity

The prospective observational MObility ImproVEment (MOVE) 2 study is collecting real-life clinical outcomes data on patients with treatment-resistant multiple sclerosis (MS) spasticity treated with THC:CBD oromucosal spray in routine clinical practice. The MOVE 2 study has been ongoing in Italy, involving more than 30 MS centres across the country, since 2013.. Web-based real-time data collection techniques are combined with traditional patients' diaries to capture a wide spectrum of outcomes associated with this innovative cannabis-based medication. After surpassing the recruitment threshold of 300 patients, an interim analysis was performed to determine whether the data collected to date align with those from MOVE 2-Germany and the largest phase III randomized controlled trial (RCT) of THC:CBD oromucosal spray.. In the Italian cohort, THC:CBD oromucosal spray was added mainly to oral baclofen. Similar to MOVE 2-Germany, during 3 months' observation, treatment discontinuations were limited and patients recorded meaningful improvements on the patient-based 0-10 numerical rating scale and physician-rated modified Ashworth scale at mean daily doses that were about one-third lower than those used in the RCT. Also, similar to MOVE 2-Germany, the proportion of patients reporting adverse events was about one-third of the rate recorded in the RCT.. While MOVE 2-Italy continues, this interim analysis has enabled us to better define the place in therapy of THC:CBD oromucosal spray within the context of daily management of our patients with MS spasticity.

Topics: Adult; Amines; Baclofen; Calcium Channel Blockers; Cannabidiol; Cohort Studies; Cyclohexanecarboxylic Acids; Dronabinol; Drug Combinations; Drug Therapy, Combination; Female; Gabapentin; gamma-Aminobutyric Acid; Germany; Humans; Italy; Male; Medical Marijuana; Middle Aged; Multiple Sclerosis; Muscle Relaxants, Central; Muscle Spasticity; Observational Studies as Topic; Oral Sprays; Plant Extracts; Pregabalin; Prospective Studies; Treatment Outcome

To determine whether pregabalin produces long-term spasticity reduction in subjects previously identified as responding in short-term trials.. Prospective service evaluation of patients taking pregabalin for spasticity management for at least 1 year through a tertiary referral rehabilitation clinic. A graduated pregabalin withdrawal was undertaken as part of routine clinical management.. Twelve of 19 potential subjects agreed to participate. The primary outcome measures were visual analogue pain and spasticity scores at lowest dose of pregabalin compared to baseline and their choice to resume pregabalin therapy.. Mean pre-withdrawal pregabalin dosage was 386 mg/day, decreasing to 70 mg/day at mean lowest dosage. Median subjective spasticity scores increased from 4 at baseline to 6 at lowest dose (p < 0.01) without a significant increase in median pain scores. Two patients with epilepsy, whose other anti-convulsants were not altered, had seizures. Following the evaluation, five subjects chose to return to the original dose, five recommenced pregabalin at a lower dose and two subjects no longer required the drug.. Pregabalin withdrawal resulted in self-reports of increased spasticity without a concomitant increase in pain, with 91% choosing to continue pregabalin at the conclusion of the evaluation.

Topics: Analgesics; Anticonvulsants; Brain Injuries; Cerebral Palsy; Drug Administration Schedule; Female; gamma-Aminobutyric Acid; Humans; Male; Middle Aged; Multiple Sclerosis; Muscle Spasticity; Pain Measurement; Pregabalin; Prospective Studies; Spinal Cord Injuries; Treatment Outcome; Withholding Treatment

To evaluate the therapeutic effects of the GABA analogue, pregabalin, on patients with conditions producing spasticity who had not responded to, or experienced problems with side-effects of the available anti-spasticity agents.. A retrospective case series review of 22 patients who were prescribed open label Pregabalin as monotherapy for spasticity, starting with 75 mg bd and increasing to 300 mg bd. Twenty one of these patients had previously tried gabapentin, 19 had tried baclofen, 7 had tried tizanidine and 3 had tried dantrolene.. Twelve patients perceived a definite reduction in symptoms of spasticity with pregabalin, and 9 continued to take it. Eight patients experienced significant side-effects which limited its use, 5 experienced no beneficial or adverse effects.. Pregabalin may be of value as a systemic agent in the treatment of spasticity, although properly controlled studies with clearly defined outcome measures are required to confirm this finding. This is relevant to the study of disability and rehabilitation because of the difficulties encountered in the management of spasticity and the impact that this can have on the rehabilitation of individuals with neurological conditions.

Topics: Adult; Aged; Anticonvulsants; Cohort Studies; Female; gamma-Aminobutyric Acid; Humans; Male; Middle Aged; Muscle Spasticity; Pregabalin; Retrospective Studies; Treatment Outcome; Young Adult

Pregabalin is a novel anticonvulsive and analgesic drug that has been marketed in Europe for more than a year. The typical side effects are dizziness, somnolence and weight gain. We present a patient who, after unintended rapid up-titration of pregabalin, experienced psychotic symptoms associated with rhythmic EEG-changes resolving completely after discontinuation of pregabalin and benzodiazepine administration.

Topics: Acute Disease; Adult; Anticonvulsants; Dose-Response Relationship, Drug; Electroencephalography; Female; gamma-Aminobutyric Acid; Humans; Muscle Spasticity; Pregabalin; Psychoses, Substance-Induced