Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03368170
• Date of registration: 05/12/2017
• Prospective Registration: Yes
• Primary sponsor: Integrative Research Laboratories AB
• Public title: Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
• Scientific title: A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
• Date of first enrolment: April 12, 2018
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03368170
• 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

Sweden, United Kingdom

Contacts

• Name: Camille Carroll, MD
• Affiliation: Plymouth University Peninsula Schools of Medicine and Dentistry

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female =18 and =79 years of age.

2. Signed a current Ethics Committee approved informed consent form.

3. Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical
Diagnostic Criteria.

4. Waking day dyskinesia of =25% determined as a score of =2 as per Question 4.1 of the
MDS-UPDRS.

5. On a stable regimen of antiparkinson medications for at least 30 days prior to
screening, including a levodopa preparation administered not less than three times
daily and willing to continue the same doses and regimens during study participation.
Rescue medication such as Madopar dispersable and Apomorphine injections are allowed.

6. Taking a maximum of eight regular levodopa intakes per day, excluding bedtime and
night time levodopa.

7. Any other current and allowed prescription/non-prescription medications and/or
nutritional supplements taken regularly must have been at a stable dose and regimen
for at least 30 days prior to screening and the patient must be willing to continue
the same doses and regimens during study participation (this criterion does not apply
to medications that are being taken pre-study only on an as-needed basis).

8. Patient must be willing and able to avoid direct exposure to sunlight from day 1 to
day 28.

9. Able to complete at least one valid 24-hour patient diary at Visit 1.

Exclusion Criteria:

1. History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain
stimulation).

2. Treatment with pump delivered antiparkinsonian therapy (i.e. subcutaneous apomorphine
or levodopa/carbidopa intestinal infusion).

3. History of seizures within two years prior to screening.

4. History of stroke or transient ischemic attack (TIA) within two years prior to
screening.

5. History of cancer within five years prior to screening, with the following exceptions:
adequately treated non-melanomatous skin cancers, localised bladder cancer,
non-metastatic prostate cancer or in situ cervical cancer.

6. Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination
(MMSE) score of less than 24 during screening.

7. A Hoehn and Yahr score of five when "off" as per Question 3.18 of the MDS-UPDRS,
assessed during screening.

8. Any history of a significant heart condition or cardiac arrhythmias within the past 5
years, any repolarisation deficits or any other clinically significant abnormal ECG as
judged by the Investigator

9. Severe or ongoing unstable medical condition including a history of poorly controlled
diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension;
cerebrovascular disease, or any form of clinically significant cardiac disease;
clinically significant symptomatic orthostatic hypotension; clinically significant
hepatic disease, renal failure or abnormal renal function.

10. Any history of a neurological other than Parkinson's disease or a psychiatric
disorder, including history of DSM IV diagnosed major depression or psychosis.
Patients with illusions or hallucinations with no loss of insight will be eligible.
Patients with mild depression who are well controlled on a stable dose of an
antidepressant medication for at least 4 weeks before screening will be eligible.

11. Enrolment in any other clinical study involving medication, medical devices or
surgical procedures, current or within three months prior to screening visit, or
previous participation in the present study. Patients enrolled in non-interventional
clinical trials will be eligible.

12. Drug and/or alcohol abuse.

13. History of severe drug allergy or hypersensitivity.

14. If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose.

15. Patients unwilling to use two forms of contraception 90 days for men and 30 days for
women after last IMP dose

16. Any planned major surgery within the duration of the study.

17. Any other condition or symptoms preventing the patient from entering the study,
according to the Investigator's judgement.



Age minimum: 18 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Mesdopetam (IRL790)

Primary Outcome(s)

Unified Dyskinesia Rating Scale (UDysRS) [Time Frame: Baseline and 4 weeks]

Secondary Outcome(s)

Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part II and III [Time Frame: Baseline and 4 weeks]

Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, Question 4.1 and 4.2 [Time Frame: Baseline and 4 weeks]

Secondary ID(s)

IRL790C003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Clinical Trial Company

Results

• Results available: Yes
• Date Posted: 24/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03368170