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Official Study Title: Phase 2, randomized, double-blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. of ADX48621 in the treatment of levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. induced dyskinesia  DyskinesiaTwisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa. in patients with Parkinson's disease
Sponsor: Addex Pharma SA
Clinicaltrials.gov ID: NCT01336088
Study ID: ADX48621-201

Summary

ADX48621 is a novel compound that is being developed for the treatment of uncontrolled movements which can occur when levodopa is taken. The compound works by reducing the activity in the brain of a chemical messenger called glutamate. The jerking (chorea) and writhing (dystonia) movements that can occur after taking levodopa, known as levodopa-induced dyskinesias, are believed to result from over activity of glutamate in certain pathways in the brain, which are affected by PD. In non-clinical models of levodopa-induced dyskinesias, ADX48621 has been shown to be effective in reducing both chorea and dystonia. In initial studies in men and women without PD aged 18 to 70 years, ADX48621 was well tolerated, with no safety concerns.

The principal objective of this study is to evaluate the safety and tolerability of four weeks treatment with ADX48621 in people with PD.  The secondary aim is to evaluate whether ADX48621 could be effective for treating levodopa-induced dyskinesias.

Study measures will include observation of abnormal movement following levodopa dosing, using the modified Abnormal Involuntary Movement Scale (mAIMs), assessment of effects on parkinsonian symptoms using Unified Parkinson’s Disease rating Scale (UPDRS) and effects on “on” and “off” time using participant diary information.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Movement Symptoms

Uncontrollable movements (Dyskinesia)

Time Commitment

• Less than six months
• Weekly for seven weeks

Eligibility

• Minimum Age: 30
• Maximum Age: 75
• Gender(s) Accepted: Either

Inclusion Criteria

• Experiences moderately disabling dyskinesia

Exclusion Criteria

• Has undergone surgical treatment for PD (e.g. deep brain stimulation)  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. within the last year or planned during the study)
• Has an unstable co-existing psychiatric disease, including cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. impairment
• Has other serious medical conditions, for example uncontrolled heart disease or uncontrolled diabetes
• Is pregnant or breast-feeding. Women who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive)

Enrollment

Expected Enrollment: 90 (US)
Date Enrollment Began: Apr 2011
Date Enrollment Ends: Oct 2011
Last Updated Date: Aug 04 2011
Trial Post Date: Aug 04 2011
Website: http://clinicaltrials.gov/ct2/show/NCT01336088

Contacts Based on Your Current Location Search

California

• Anna Woods
  Parkinson's Institute
  awoods@parkinsonsinstitute.org
  Phone: (408) 734-2800
  675 Almanor Avenue
  Sunnyvale, CA 94085
  USA
  

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