Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT01538329
• Date of registration: 20/02/2012
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Toulouse
• Public title: Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease PREMANDYSK
• Scientific title: Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study)
• Date of first enrolment: March 4, 2012
• Target sample size: 210
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01538329
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Olivier Rascol, MD
• Affiliation: University Hospital, Toulouse

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age over 35 years,

- Patients having signed an informed consent before any specific study procedures,

- Patients having a health Insurance Coverage (according to local regulatory
requirements),

- Patients suffering from idiopathic Parkinson's disease meeting the definition criteria
of the UKPD Brain Bank (Gibb and Lees, 1988),

- Parkinson's disease diagnosed for <3 years,

- Patients receiving treatment with L-DOPA from <1year,

- Lack of complications of levodopa therapy

- Patients receiving a stable antiparkinsonian treatment that may involve, in addition
to L-DOPA, a dopamine agonist, a monoamine oxidase-B (MAO-B) or a catecholamine
O-methyl transferase (COMT) inhibitor, an anti-cholinergic for at least 2 months
before enrollment and in whom we presume it will be possible to maintain this
treatment unchanged during the study period (except the dose of L-dopa which can be
adjusted during the study after the third month of Phase 1).

Exclusion Criteria:

- Atypical parkinsonian syndromes,

- Drug-induced Parkinsonism,

- Juvenile Parkinson,

- Patients with complications of levodopa therapy

- Inability to keep the current stable antiparkinsonian treatment during the study
period, apart from L-DOPA,

- Pretreatment with amantadine,

- amantadine counter-indication

- Neuroleptic treatment,

- Patients with dementia, Mini Mental Status (MMS) <26,

- Patient with behavioral disorder, ECMP item = 3

- Female subjects of childbearing potential without effective contraception



Age minimum: 35 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: placebo

Drug: Amantadine

Primary Outcome(s)

after 18 months of Phase 1 of the study [Time Frame: after 18 months of follow-up]

Secondary Outcome(s)

motor fluctuations after 18 months of Phase 1 of the study [Time Frame: 18 months after inclusion]

Time to onset of dyskinesias [Time Frame: each visits]

abnormal involuntary dyskinetic movements at the end of phase 3 of the study (wash out) [Time Frame: 22 months after inclusion]

Secondary ID(s)

11 253 01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors