A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-010193-38-LT
• Date of registration: 26/03/2009
• Prospective Registration: Yes
• Primary sponsor: IMPAX Pharmaceuticals a Division of IMPAX Laboratories, Inc.
• Public title: A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease
• Scientific title: A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease
• Date of first enrolment: 02/06/2009
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010193-38
• 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

Countries of recruitment

Estonia, Latvia, Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
1. Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.

2. Diagnosed with idiopathic PD as defined by meeting United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria without any known cause for Parkinsonism.

3. Male or female at least 30 years old at the time of PD diagnosis.

4. Hoehn and Yahr Staging I, II, or III.

5. Mini-Mental State Exam (MMSE) = 26 at Screening.

6. LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.

7. The sum of UPDRS Parts II and III scores = 18 at Screening and Baseline.

8. If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.

9. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study. Medically acceptable methods of contraception that may be used by the subject and/or partner include, but are not limited to, abstinence, oral contraception, NuvaRing® or transdermal systems, diaphragm with vaginal spermicide, intra-uterine device, condom and partner using vaginal spermicide, surgical sterilization (>6 months), progestin implant or injection, or postmenopausal female (no menstrual period for > 2 years) or vasectomy (>6 months).

10. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnant or breastfeeding.

2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome (e.g., vascular, toxin or medication-induced, metabolic, or infectious) or other neurodegenerative disorder with Parkinsonism (i.e.,progressive supranuclear palsy, corticobasal degeneration, multiple-system atrophy).

3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.

4. Use of nonselective MAO inhibitors.

5. Use of dopamine agonists within 30 days prior to Screening.

6. Unable to tolerate a placebo regimen, in the Investigator’s opinion.

7. Sensitivity to CD-LD or to IPX066 or its excipients.
8. Treatment of psychosis with any antipsychotic, including atypical antipsychotics within the 2 years prior to Screening. Treatment for conditions other than psychosis, such as sleep aid, is allowed.

9. History of seizure or epilepsy, or currently taking an anticonvulsant for treatment of seizure disorder.

10. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedure that would interfere with LD absorption.

11. History of narrow-angle glaucoma.

12. Subjects with a history of malignant melanoma or a suspicious undiagnosed skin lesion, which in the opinion of the Investigator could be melanoma.

13. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.

14. Abnormal kidney function (i.e., serum creatinine level = 1.5 times the upper limit of normal (ULN) at Screening or requires dialysis.

15. Liver transaminase values = 2 times the ULN at Screening.

16. Received any investigational medications during the 30 days prior to Screening.

17. Subjects who, in the opinion of the clinical Investigator, should not participate in the study.

18. Employees or family members of the Investigator, study site or the sponsor.


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

Health Condition(s) or Problem(s) studied

Idiopathic Parkinson's disease (paralysis agitans)
MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease

Intervention(s)

Product Name: IPX066
Product Code: IPX066-95
Pharmaceutical Form: Capsule*
INN or Proposed INN: LEVODOPA
CAS Number: 59927
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 95-
INN or Proposed INN: CARBIDOPA
CAS Number: 28860959
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 23.75-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: IPX066
Product Code: IPX066-145
Pharmaceutical Form: Capsule*
INN or Proposed INN: LEVODOPA
CAS Number: 59927
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 145-
INN or Proposed INN: CARBIDOPA
CAS Number: 28860959
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 36.25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: IPX066
Product Code: IPX066-195
Pharmaceutical Form: Capsule*
INN or Proposed INN: LEVODOPA
CAS Number: 59927
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 195-
INN or Proposed INN: CARBIDOPA
CAS Number: 28860959
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48.75-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: IPX066
Product Code: IPX066-245
Pharmaceutical Form: Capsule*
INN or Proposed INN: LEVODOPA
CAS Number: 59927
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 245-
INN or Proposed INN: CARBIDOPA
CAS Number: 28860959
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 61.25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: An additional objective is to evaluate the impact of IPX066 on the quality of life in subjects with early Parkinson´s disease.

Primary end point(s): Change from Baseline in the sum of Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II and III score at Week 30.

Main Objective: The objective of this study is to evaluate the safety and efficacy of IPX066 in the treatment of subjects with early Parkinson´s disease.

Secondary ID(s)

IPX066-B08-05