- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00914095
Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II) (PARKGAIT-II)
Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentric Trial
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Overall study duration: 2 years. Planned inclusion period: 12 months. Study duration for individual patients: 4 months and 2 weeks(2 weeks between screening and randomization, 3 months of double-blind treatment and then a 4-week wash-out period).
Primary objective (V1 and V4):
To assess efficacy of methylphenidate treatment on severe gait disorders including freezing assessed by the Stand Walk Sit Test in patients with advanced Parkinson's disease without dementia or depression and under subthalamic stimulation
Additional Efficacy Endpoints (V1 and V4):
- Gait and motor symptoms: the "Freezing Of Gait trajectory", RGSE scale, the UPDRS scores (partI, II, III, IV), the dyskinesia rating scale
- auto-questionnaires of Giladi, ABC scale and PDQ 39
- Attention: simple and complex reactions times
- Drowsiness: Epworth and Parkinson's disease Sleep Scales
- Apathy Lille Apathy Rating Scale
- Depression and other psychiatric disorders: MADRS, BPRS, MINI and psychiatric interview
Safety and Tolerability Endpoints (V1, V2, V3 and V4):
Tolerability Number of subjects (%) who discontinue the study Number of subjects (%) who discontinue the study due to AEs Safety Measures AE incidence Safety laboratory values Vital signs Blood pressure monitoring ECG Physical and neurological examination
Study Design:
Multicentric study: 12-week double blind, placebo-controlled phase. After being found eligible to participate in the study, subjects will be allocated in a 1:1 ratio into one of the following two treatment groups based on a randomization scheme with blocks stratified:
one methylphenidate
- 1st week: 1/2cp 3 times a day (morning, at noon and at 16h)
- 2nd week: 1cp 3 times a day
- 3rd week: 1cp + 1/2cp 3 times a day
- 4th week: depending on the weight: 2 to 3 cp 3 times a day (1 mg/kg/day)
During the 2 following month: 2 to 3 cp 3 times a day (1 mg/kg/day) one placebo during 3 months same as methylphenidate
Schedule: 10 visits Six short consultations: screening (V0), safety visits every 15 days (V2, V3, V4, V5, V6) and two last consultation for the decrease titration (V8, V9) Two long visits during an hospitalization of two days: randomization (V1, 15 days after V0) and visit of termination (V7, 3 months after randomization)
Patients 76 subjects with Parkinson's disease duration of more than 5 years, without dementia (Mattis Dementia Rating Scale ≥ 130, MMSE ≥ 27 and DSM IV), without major depression (MADRS < 18) who have severe gait disorders including freezing of gait (defined by an answer 2 or 3 at the 3rd question of the autoquestionnaire of Giladi: Do your gait disorders impede your daily living activities and your independence: answer: yes, moderately or severely. But the patient requires no physical assistance to walk) despite an optimal dopaminergic treatment and optimal and if present stable subthalamic stimulation parameters. No additional therapy will be permitted during the study.
Centres :
LILLE :
Neurological department, CHU de Lille, EA 2683, IFR 114 : Pr L. Defebvre, Pr K. Dujardin, Dr D. Devos, Pr Destee, Mme Delliaux. Dr A Kreisler, Dr C Simonin, Dr C. Moreau, Dr A. Delval Department of Pharmacology, Faculté de Médecine, Lille II, EA 1046, IFR 114 : R. Bordet.
CHU AMIENS :Pr. P. KRYSTKOWIAK Place Victor PAUCHET - 80054 AMIENS Cedex 1. CH AIX EN PROVENCE : Dr F. VIALLET Avenue Tamaris - 13616 AIX-en-PROVENCE. APHP - HOPITAL DE LA PITIE SALPETRIERE : Pr M. VIDAILHET 47-83, Boulevard de l'Hôpital - 75 PARIS 13ème CHU BORDEAUX : Pr. F. TISON 1, Avenue Magellan - 33600 PESSAC CHU CLERMONT-FERRANT : Pr. F. DURIF 58, Rue Montalambert - 63000 CLERMONT-FERRRAND CHU CRETEIL : Pr. P. CESARO 51, Avenue du Maréchal de Lattre de Tassigny - 94000 CRETEIL CHU GRENOBLE : Pr P. POLLAK Bd de la Chantourne - BP 217 - 38700 La Tronche. CHU MARSEILLE : Pr. JP AZULAY Hôpital de la Timone - 13385 MARSEILLE cedex 05 CHU NANTES : Pr PH. DAMIER Hôtel-Dieu - Place Alexis Ricordeau - 44093 Nantes cedex 1 CHU POITIERS : Dr JL HOUETO 2, Rue de la Milétrie - 86000 POITIERS. CHU RENNES : Pr. M. VERIN CHU Pontchaillou , Rue H. Le Guilloux - 35033 Cedex 9. CHU ROUEN :DR D. MALTETE
1, Rue Germont - 76000 ROUEN. CHU TOULOUSE : Pr. O. RASCOL Hôpital Purpan - Place du Docteur Baylac - TSA 40031 - 31059 Toulouse cedex 9. CHU STRASBOURG : Pr. C. TRANCHANT Hôpital civil - 1 place de l'hôpital BP 426 - 67091 Strasbourg cedex CHU CAEN : Pr. G. DEFER Avenue Côte de Nacre - 14000 CAEN. CHU NICE : M. BORG Hôpital Pasteur - 30, Avenue de la Voie Romaine - 06000 NICE Promoteur de l'étude : CHRU de Lille
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
-
Lille, Frankrike, 59037
- Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Parkinson's disease of more than 5 years
- Subthalamic nucleus stimulation
- Gait disorders impeding moderately to severely the activities of daily living
- gait disorders including freezing of gait
- able to walk without physical assistance
Exclusion Criteria:
- Dementia (MMSE < 27 et score de Mattis < 130)
- Requiring dopatherapie modification
- Requiring subthalamic stimulation parameters adaptation
- Psychiatric disorders: hallucinations, unstable thymic disorders, psychosis)
- Cardiac disorders: dysrhythmia or unstable arterial hypertension
- Unstable or severe medical illness
- intolerance or contraindication to methylphenidate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: methylphenidate
methylphenidate 10 mg tablets (1 mg /kg /day) 3 time a day
|
10 mg tablet of methylphenidate 3 times a day (1 mg/kg/day)
Andre navn:
|
Placebo komparator: placebo
tablets of placebo 3 time a day
|
tablets of placebo 3 times a day
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of steps on the Stand Walk Sit Test
Tidsramme: 3 months
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
UPDRS
Tidsramme: 3 måneder
|
3 måneder
|
time on the stand walk sit test
Tidsramme: 3 months
|
3 months
|
number of freezing on the FOG trajectory
Tidsramme: 3 months
|
3 months
|
RGSE
Tidsramme: 3 months
|
3 months
|
psychiatric interview
Tidsramme: 3 months
|
3 months
|
Cardiac examination with ECG and blood pressure
Tidsramme: 3 months
|
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: David Devos, MD, PhD, Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114, IMPRT
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Devos D, Krystkowiak P, Clement F, Dujardin K, Cottencin O, Waucquier N, Ajebbar K, Thielemans B, Kroumova M, Duhamel A, Destee A, Bordet R, Defebvre L. Improvement of gait by chronic, high doses of methylphenidate in patients with advanced Parkinson's disease. J Neurol Neurosurg Psychiatry. 2007 May;78(5):470-5. doi: 10.1136/jnnp.2006.100016. Epub 2006 Nov 10.
- Moreau C, Meguig S, Corvol JC, Labreuche J, Vasseur F, Duhamel A, Delval A, Bardyn T, Devedjian JC, Rouaix N, Petyt G, Brefel-Courbon C, Ory-Magne F, Guehl D, Eusebio A, Fraix V, Saulnier PJ, Lagha-Boukbiza O, Durif F, Faighel M, Giordana C, Drapier S, Maltete D, Tranchant C, Houeto JL, Debu B, Azulay JP, Tison F, Destee A, Vidailhet M, Rascol O, Dujardin K, Defebvre L, Bordet R, Sablonniere B, Devos D; Parkgait-II Study Group. Polymorphism of the dopamine transporter type 1 gene modifies the treatment response in Parkinson's disease. Brain. 2015 May;138(Pt 5):1271-83. doi: 10.1093/brain/awv063. Epub 2015 Mar 23.
- Dujardin K, Tard C, Duhamel A, Delval A, Moreau C, Devos D, Defebvre L. The pattern of attentional deficits in Parkinson's disease. Parkinsonism Relat Disord. 2013 Mar;19(3):300-5. doi: 10.1016/j.parkreldis.2012.11.001. Epub 2012 Nov 27.
- Moreau C, Delval A, Defebvre L, Dujardin K, Duhamel A, Petyt G, Vuillaume I, Corvol JC, Brefel-Courbon C, Ory-Magne F, Guehl D, Eusebio A, Fraix V, Saulnier PJ, Lagha-Boukbiza O, Durif F, Faighel M, Giordana C, Drapier S, Maltete D, Tranchant C, Houeto JL, Debu B, Sablonniere B, Azulay JP, Tison F, Rascol O, Vidailhet M, Destee A, Bloem BR, Bordet R, Devos D; Parkgait-II study group. Methylphenidate for gait hypokinesia and freezing in patients with Parkinson's disease undergoing subthalamic stimulation: a multicentre, parallel, randomised, placebo-controlled trial. Lancet Neurol. 2012 Jul;11(7):589-96. doi: 10.1016/S1474-4422(12)70106-0. Epub 2012 Jun 1. Erratum In: Lancet Neurol. 2012 Aug;11(8):658. Lancet Neurol. 2016 Mar;15(3):241. Lancet Neurol. 2016 Mar;15(3):241.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Nevrologiske manifestasjoner
- Parkinsonlidelser
- Basal ganglia sykdommer
- Bevegelsesforstyrrelser
- Synukleinopatier
- Nevrodegenerative sykdommer
- Parkinsons sykdom
- Sykdommer i nervesystemet
- Gangforstyrrelser, nevrologisk
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Nevrotransmitter opptakshemmere
- Membrantransportmodulatorer
- Dopaminmidler
- Dopaminopptakshemmere
- Sentralnervesystemstimulerende midler
- Metylfenidat
Andre studie-ID-numre
- 2008-005801-20
- 2008_25/0832 (Annen identifikator: sponsor)
- PHRC 2008/1918 (Annen identifikator: DHOS)
- A90135-48 (Annen identifikator: AFSSAPS)
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