Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.

• Register: EUCTR
• Last refreshed on: 29 January 2018
• Main ID: EUCTR2011-005839-91-ES
• Date of registration: 11/01/2012
• Prospective Registration: Yes
• Primary sponsor: ASOCIACIÓN INSTITUTO BIODONOSTIA
• Public title: Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.
• Scientific title: Gabapentin int he disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo. - IMULPARK
• Date of first enrolment: 02/04/2012
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005839-91
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: UNIDAD DE ENSAYOS CLINICOS
• Affiliation: ASOCIACION INSTITUTO BIODONOSTIA

• Name: UNIDAD DE ENSAYOS CLINICOS
• Affiliation: ASOCIACION INSTITUTO BIODONOSTIA

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

PARKINSON´S DISEASE
MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: EVERY VISIT

Primary end point(s): Score in the Questionnaire for Impulsive-Compulsive Disorders in Parkinson´s Disease- Rating Scale.

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.

Secondary Outcome(s)

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

Secondary ID(s)

IMPULPARK

Source(s) of Monetary Support

MINISTERIO DE SANIDAD Y POLITICA SOCIAL