PARKINSON´S DISEASE MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: GABAPENTINA KERN PHARMA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: GABAPENTINA
CAS Number: 60142-96-3
Other descriptive name: GABAPENTIN
Concentration unit: mg milligram(s)
Co
Sponsors
ASOCIACIÓN INSTITUTO BIODONOSTIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with Parkinson´s disease treated with dopaminergic drugs. 2.Subjects that present disorder of impulse control according to the validated diagnostic criteria (parkinson´s Disease Impulsive-compulsive Disorders diagnostic interview; Weintraub et al, Mov Disror 2009;30:1461-7) who after the gradual reduction of the dopaminergic treatment continue presenting disrorder of the impulse control. 3.Older than 18 years old. 4.Signed informed content. 5.Women of childbearing age should get a negative pregnancy test in serum or urine at the screening visit, and accept the use of adequate contraception for at least 14 days before the first dose of study drug to the 14 days after the last. Postmenopause is defined as the absence of menstruation during the year prior to study entry. 6.In men with couples of childbearing age, accept the use of contraceptive methods. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1.Subjects with psycosis (hallucination, delirium, etc). 2.Subjects with dementia. 3.Subjects treated through deep cerebral stimulation for the Parkinson´s Disease or any other cerebral intervention. 4.Subjects with renal failure. 5.Patients treated with antiepileptic drugs. 6.Patients treated with atypical neuroleptic drugs. 7.Subjects with physical or psychical inability to participate in the study. 8.Pregnant women or under lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficay of gabapentin versus placebo in the disorder of impulse control in the Parkinson´s disease, using for its evaluation the Questionnaire for Impulsive-Compulsive Disorder in Parkinson´s Disease.;Secondary Objective: 1.To verify if the treatment with gabapentin leads to changes in the Parkinson´s motor state. 2.To evaluate if gabapentin modifies the anxiety and depression associated to the disorder of impulse control in the Parkinson´s disease. 3.To analyze if gabapentin has any other effect on the motor aspects related to the Parkinson´s Disease. 4.To study if the treatment with gabapentin associates to apathy. 5.To determine the effect of gabapentin versus placebo in the patient´s quality of life. 6.To verify the security and tolerability of gabapentin, evaluated by the presence of secondary effects. ;Primary end point(s): Score in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson´s Disease- Rating Scale. ;Timepoint(s) of evaluation of this end point: EVERY VISIT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Score in the Unified Parkinson´s Disease Rating Scale, motor section that evaluates the degree of parkinsonism (UPDRS-III). 2. Score in the Unified Parkinson´s Disease Rating Scale, motor complications section, which evaluates motor fluctuations and dischinesia (UPDRS-IV). 3. Score in the PDQ39 (quality of live). 4. Score in the Parkinson´s Disease Rating Scale daily life activities section (UPDRS-II). 5. Score in the Starkstein apathy scale and impulsivity in the Barrat scale. 6. Score in the Hamilton ansiety and depression scale (HADS). 7. Presence of motor symptom detected in the scale of Parkinson´s Disease Nonmotor Symptoms Questionnaire (NMSQ). 8. Score in the sleepiness scale of Epworth. 9. Incidence of secondary effects in patients treated with gabapentin and placebo. ;Timepoint(s) of evaluation of this end point: EVERY VISIT | — |
Countries
Spain
Contacts
Public ContactUNIDAD DE ENSAYOS CLINICOS
ASOCIACION INSTITUTO BIODONOSTIA
Outcome results
None listed